Protocol

Study of Hyperkyphosis, Exercise and

Function (SHEAF) Protocol of a W.B. Katzman, PT, DPTSc, OCS,
Departm ent of Physical Therapy
Randomized Controlled Trial of and Rehabilitation Science, Uni
versity of California, San Francisco,
Multimodal Spine-Strengthening Exercise UCSF Box 0625, San Francisco, CA
94143-0625 (USA). Address all

in Older Adults With Hyperkyphosis correspondence to Dr Katzman at:

wendy.katzman@ ucsf.edu.

Wendy B. Katzman, Eric Vittinghoff, Deborah M. Kado, Anne L. Schafer, E. V itting ho ff, PhD, D epartm ent of
Shirley S. Wong, Amy Cladin, Nancy E. Lane Epidem iology and Biostatistics,
University of California, San
Francisco.
Background. Hyperkyphosis negatively affects health status, physical mobility, and qual
D.M . Kado, MD, MS, Depart
ity of life, but there is no standard protocol for treating people with hyperkyphosis. Treatment ments of Family M edicine and
options include targeted exercise. Public Health and Internal M ed i
cine, University of California, San
Objectives. This single-site randomized controlled trial (RCT) will determine the efficacy Diego, California.
of a targeted multimodal spine-strengthening exercise program, compared with no exercise
intervention, among community-dwelling men and women aged 2:60 years. A.L. Schafer, MD, D epartm ent of
Epidem iology and Biostatistics
Design. The RCT is a parallel-group design, with 1:1 randomization to exercise and atten- and Departm ent of Medicine, Uni
tional control groups. versity of California, San Francisco,
and Medical Service, San Fran
Setting. The study will be conducted at one primary site (one academic medical center cisco Veterans Affairs Medical
partnered with one local community medical center). Center, San Francisco, California.

Participants. One hundred men and women, aged &60 years, with thoracic kyphosis >40 S.S. W ong, BS, D epartm ent of
Physical Therapy and Rehabilita
degrees will be randomized.
tion Science, University of Califor
Intervention. The targeted multimodal spine-strengthening exercise intervention nia, San Francisco.
includes exercise and postural training delivered by a physical therapist in a group of 10 A. Gladin, PT, MPT, DPT, OCS,
participants, 3 times a week for 6 months. Controls receive monthly health education meetings Kaiser Permanente Northern Cali
in a group of 10 participants and monthly calls from the study coordinator to monitor physical fornia, San Francisco Medical Cen
activity and any adverse events. ter, San Francisco, California.

Measurements. The primary outcome is change in Cobb angle of kyphosis measured N.E. Lane, M D, D epartm ent of
Internal Medicine, University of
from lateral spine radiographs at baseline and 6 months. Secondary outcomes include change
California, Davis, Davis, California.
in physical function (assessed with the modified Physical Performance Test, Timed "Up & Go
Test, timed loaded standing, 4-m walk, and Six-Minute Walk Test) and health-related quality of [Katzman WB, V ittin g h o ff E, Kado
life (assessed with the modified Scoliosis Research Society instrument fSRS-30] self-image DM , et al. Study of Hyperkypho
domain and Patient Reported Outcomes Measurement Information System [PROMIS] global sis, Exercise and Function (SHEAF)
health and physical function indexes). Additional secondary outcomes include pain, physical protocol of a random ized con
trolled trial o f m ultim odal spine
activity level, spinal flexion and extension muscle strength, paraspinal extensor muscle den
strengthening exercise in older
sity, and adverse events.
adults w ith hyperkyphosis. P h ys
Limitations. Blinding of the participants and instructors providing the intervention is not T h e r. 20 16 ;9 6 :3 7 1 -3 8 1 .]

possible. 2016 American Physical Therapy

Association
Conclusions. The efficacy of a high-quality, adequately powered exercise intervention in
men and women with kyphosis >40 degrees will be evaluated to determine whether targeted Published Ahead of Print:
multimodal spine-strengthening exercise reduces hyperkyphosis in older adults and improves August 6, 2015
important secondary outcomes of physical function and health-related quality of life. Accepted: August 2, 2015
Submitted: March 25, 2015

P o s t a R a p id R e s p o n s e t o
t h is a r t ic le a t:
p tjo u rn a l.a p ta .o rg

March 2016 Volum e 96 Num ber 3 Physical Therapy 371

Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol

ge-related hyperkyphosis, an exercises designed to reduce kyphosis Trial Design

A abnormal forward curvature in will lead to improvement in physical This is a single-blinded RCT com
the thoracic spine, is a common function. Spinal orthoses reportedly paring a 3-times-per-week group exercise
progressive deformity of the spine reduce
that excessive kyphosis and improve intervention with a monthly health edu
affects up to 50% of older adults.1-3 spinal extensor muscle strength and cation group class (ClinicalTrials.gov
Hyperkyphosis can lead to significant physical performance, although Identifier NCTO1751685) with a 1:1 allo
deterioration in health status, physical they have only been tested in women cation ratio. Five waves of 20 partici
mobility, and quality of life. Women with with underlying spinal osteoporosis.18 pants are enrolled in the study, with 10
hyperkyphosis have slower walking participants randomized to the interven
speeds; difficulty' climbing stairs; Based on the results of our previous pilot tion group and 10 participants random
impaired balance; and greater risk for study, we designed an adequately pow ized to the control group in each wave
falls, fractures, and mortality.2-4-8 Risk ered. high-quality RCT to test the hypoth (Figure). Participants are randomized in
factors for hyperkyphosis include esis that a targeted multimodal spine equal proportions to intervention and
advanced age, low bone mass, degener strengthening exercise program will lead control groups using randomly per
ative disk disease, and prevalent verte to a clinically meaningful change in muted blocks of 2 and 4, stratified by age
bral fractures.9-11 Routine poor posture, kyphosis in community-dwelling adults and sex. Treatment assignments are gen
decreased spinal extension mobility, and with hyperkyphosis aged >60 years. erated prior to the study and placed in
reduced back extensor muscle strength The rationale underlying such an inter order in sealed, opaque envelopes with
are other commonly cited potential vention is that hyperkyphosis increases stratum-specific sequential ID numbers.
causes of age-related hyperkyphosis,12-14 with age, contributes to impaired physi Consenting participants fulfilling study
and these impairments may be modifi cal function, and will be improved by an eligibility criteria are assigned the next
able with exercise. exercise intervention targeting musculo available ID number for the appropriate
skeletal impairments associated with age and sex stratum by the study staff.
Despite the adverse effects on health, hyperkyphosis. The envelope is opened at the end of
physical function, and quality of life, their baseline study visit. The date and
hyperkyphosis has only recently started We are conducting a single-blinded RCT time each envelope is opened are
to be recognized by health care provid of a multimodal spine-strengthening recorded in a log along with participant
ers as a major health concern.15 There is exercise intervention: (1) to determine if ID to ensure integrity of the
no standard of care for treating hyperky the exercise intervention improves randomization.
phosis. Current treatment options kyphosis, measured as Cobb angle using
include exercise and bracing. We con lateral spine radiographs; (2) to deter Participants
ducted an uncontrolled pilot study of an mine if the exercise intervention Individuals are eligible who are age 60
exercise program targeting spinal muscle improves secondary outcome measures years and older with kyphosis angle >40
strength among older women with of physical function and health-related degrees, as measured with the Debrun-
hyperkyphosis that resulted in significant quality of life, measured using the mod ner kyphometer (Techmedica Inc, Cam
improvements in kyphosis, spinal muscle ified Physical Performance Test (modi arillo, California). After meeting prelimi
strength, and physical performance.16 A fied PPT), gait speed. Timed Up & Go nary study criteria, a study physician
recent systematic review, including 7 Test, timed loaded standing, modified reviews each participants medical his
randomized controlled trials (RCTs) to Scoliosis Research Society (SRS-30) tory, and a letter is sent to his or her
determine the effects of exercise on instrument self-image domain, and primary care provider for signed
kyphosis, showed that exercise targeting Patient Reported Outcomes Measure approval to participate in the planned
back extensor muscle strength may ment Information System (PROMIS) exercise intervention. Exclusion criteria
result in a modest improvement in global health and physical function include inability to extend the thoracic-
kyphosis.17 However, a clear recommen indexes; and (3) to determine if the exer spine at least 5 degrees, failure to adhere
dation for a treatment intervention was cise intervention improves spinal muscle to run-in procedures, non-English speak
not possible due to the small sample strength or spinal muscle density, or ing, and a disorder or disease likely to
sizes, heterogeneity of the study partici both, and if change in these factors is prevent or interfere with safe participa
pants, and different and nonvalidated associated with change in physical tion in a group-based exercise class,
measurements of the outcome variable function. including painful vertebral fractures in
of kyphosis. There is a need to perform a
high-quality RCT that is adequately pow Method
ered and uses validated outcome mea g v Available W ith
Study Setting
surements of kyphosis to determine Q l This Article at
The study is conducted at the University
whether targeted spine strengthening ptjournal.apta.org
of California San Francisco (UCSF), an
reduces hyperkyphosis in older adults.
academic medical center, with a second
Furthermore, few of the prior studies Video of Selected Exercises Used
intervention location at the Kaiser Per-
included outcome measures of physical in the Intervention
manente Northern California (KPNC)
function, and it is not known whether
San Francisco Medical Center.

372 Physical Therapy Volume 96 Number 3 March 201 6


Figure.
F lo w c h a rt o f th e ra n d o m iz e d
3 0 = m o d ifie d Scoliosis Research S ociety in s tru m e n t, PROMIS = P atient R eported O u tco m e s
M e a s u re m e n t In fo rm a tio n System,
m o n th s fo r in te rv e n tio n g ro u p o n ly (e x c lu d in g CT).
the previous 3 months, unexplained
weight loss >10 lb 11 lb=0.4536 kg] in
the previous year), 3 or more falls in the
previous year, advanced disability or end-
stage disease, major psychiatric illness,
cognitive impairment (failed Mini-Cog
test),19 alcohol or drug abuse (diagnosed
by primary care provider), narcotic pain
medications, diagnosed vestibular or pro
gressive neurologic disorder, total hip or
knee replacement or hip fracture within
the previous 6 months, or oral glucocor
ticoid medications for >3 months in the
previous year. Participants are excluded
if unable to pass safety' tests (gait speed
<0.6 m/s, inability to stand with feet
together for 30 seconds, inability to
actively flex shoulders to 90, and inabil
ity to move from standing to supine on a
mat and return to standing indepen
dently or with the use of a nearby chair).
M a rch 2 0 1 6
S tudy o f H yp erkyp h o sis, Exercise an d F unction (SHEAF) P rotocol
c o n tro lle d trial. PPT=Physical P erform ance Test,
C T = c o m p u te d to m o g ra p h y . Asterisk
In te rv e n tio n
The intervention is a multimodal, group-
based, kyphosis-specific exercise pro
gram that was developed and initially
tested during our previous pilot study.16
The exercise program targets multiple
musculoskeletal impairments that are
known to be associated with hyperky
phosis, including spinal extensor muscle
weakness, decreased spinal mobility, and
poor postural alignment (Tab. I). The
spinal strengthening component incor
porates high-intensity strengthening
exercise targeted to strengthen spinal
extensor muscles and stabilize the trunk
in neutral alignment. The spinal mobil
ity component incorporates foam rollers
and end-range exercises to increase spi
nal extension and rotation and reduce
mobility limitations in the anterior shoul
ders, chest, and spine. Participants lie
supine on foam rollers and perform side-
lying and standing end-range thoracic
extension and rotation to mobilize the
spine during exercise. The spinal align
ment component integrates spinal exten
sor strength and mobility into practice.
The instructor trains participants to rec
ognize neutral spinal alignment and
maintain their best spinal alignment dur
ing the group exercise program and dur
ing activities of daily living. Participants
are asked to practice good posture at
least 3 times during the day and to report
adherence to the study coordinator on a
weekly basis. Participants are instructed
not to change their usual level of activity
or exercise during study enrollment.
We standardized the protocol with a
written pamphlet/script and a video (see
video, available at ptjournal.apta.org).
Each exercise session begins with 10
minutes of warm-up activity and ends
with 5 minutes of cool-down and stretch
ing of the neck, chest, and all extremi
ties. A licensed physical therapist teaches
the intervention. A research assistant is
present during exercise class to assist the
physical therapist.
Setting and supervision. A group-
SRS-
based intervention led by a physical ther
indica tes 12
apist is implemented to ensure that par
ticipants learn from a professional skilled
at exercise instruction in an older popu
lation with multiple medical comorbidi
ties. The physical therapist is assisted by
a trained research assistant to ensure a
participant to instructor ratio of 5:1. The
instructors include (1) auditory, visual,
and tactile feedback to participants to
ensure safe performance of the exercises
and (2) instructions to integrate good
body mechanics and posture into the
exercises and activities of daily living.
Exercises are progressed in frequency
and intensity during the study as long as
participants are able to demonstrate
good-quality movement. If a participant
has pain >6/10, he or she is instructed
not to attend class, to contact his or her
medical provider, and to use analgesic
medications (Tylenol [McNeil Consumer
Healthcare, Div of McNeil-PPC Inc, Fort
Washington, Pennsylvania] 1.5 g, up to
3.0 g per day, or Voltaren gel [Novartis
Pharmaceuticals Corp, East Hanover,
New Jersey] applied over the painful
V o lu m e 9 6 Num ber 3 Physical T h e ra p y 373
 S tudy o f H yperkyphosis, Exercise an d Function (SHEAF) Protocol

Table 1.
M u ltim o d a l Spine S tre n g th e n in g Exercise In te rv e n tio n Fram ew ork

E x e rc is e T a rg e t R e p e t it io n s E q u ip m e n t

S p in a l s t r e n g t h e n in g : s t r e n g t h e n in g t r u n k m u s c le s ( 2 0 m in )
P ro g r e s s w e ig h t s a n d T h e r a - B a n d t o " s o m e w h a t h a r d t o h a r d ," 7 0 % - 8 0 % m a x i m u m

Supine transversus abdom inis on S tability o f tru n k w ith m o b ility o f extrem ities, 10 repetitions x 1 Roller
roller strengthen transversus abdom inis muscle

Q uadruped arm and leg lift Stability o f tru n k w ith m o b ility o f extrem ities; 8 repetitions X 2 C uff w eights
strengthen low er trapezius, spinal
extensor, m ultifidus, and transversus
abdom inis muscles

Prone tru n k lift to neutral Thoracic, lum bar, and hip extensor 8 repetitions x 2 Bolster, cuff
strengthening w eights
Side-lying thoracic Thoracic extension and ro ta tio n w ith 8 repetitions x 2 Thera-Band
rotation/extension scapulothoracic retraction/depression
stre n g th en ing and m o b ility in extension
and rota tio n

Side-lying h ip abductio n/e xte rna l Strengthen gluteus m edius muscle fo r 8 repetitions X 2 C uff w eights
rotation sta b ility in stance

S p in a l a lig n m e n t : w a r m - u p , i n t e g r a t e p o s t u r a l s t a b ili t y in t o m o b i l i t y t r a i n i n g ( 2 0 m in )

M arching on roller Increase heart rate and w arm -u p "core " 10 repetitions x 1 Roller
muscles

Unilateral overhead reaching on Increase heart rate and increase shoulder 10 repetitions x 1 Roller
roller fle xib ility

Bilateral p ull-do w n supine on Increase heart rate and im prove shoulder and 10 repetitions x 1 Thera-Band,
roller chest fle xib ility roller
Shoulder fle xio n /tho ra cic Stability o f tru n k w ith m o b ility in shoulders 10 repetitions x 1 Body w e ig h t
extension at wall and thoracic spine, strengthen low er
trapezius/serratus anterior muscles

Wall push-ups Stability o f tru n k w ith m o b ility in arms, 10 repetitions x 1 Body w e ig h t

scapular stabilization

Single-leg stance S tability o f tru n k d urin g unilateral stance 10 repetitions X 1 Body w e ig h t

S p in a l m o b i lit y : r a n g e o f m o t io n e x e r c is e s u s in g a s t r e t c h s t r a p as n e e d e d ( 1 5 m in )

Chest/spine stretching supine/ Lengthen pectoralis m ajor muscle, expand D uring w arm -u p Roller
roller rib cage and a nterior chest wall

Gluteal stretching Lengthen posterior hip capsule and gluteal Passive 30-s hold X 1
muscles

Supine straight-leg raise Lengthen ham string and gastrocnem ius- Passive 30-s hold X 1 Stretch strap
soieus muscles

Prone h ip/quadriceps stretch Lengthen iliopsoas and quadriceps muscles Passive 30-s hold x 1 Stretch strap
Q uadruped thoracic extension Increase tho ra cic spine extension and Passive 30-s hold X 2
stretch lengthen a nte rio r chest w all m usculature

N eck/chest stretch standing C ool-dow n, lengthen trapezius and anterior Passive 30-s hold X 3
chest wall m usculature positions

D ia p h r a g m a t i c b r e a t h in g : coordinated th ro u g h o u t, breathing into th e concavity, exhaling w ith pelvic-floor and deep a bdom inal muscle
contraction

P o s t u r a l c o r r e c t io n : practice at least 3 times a day d u rin g activities o f daily living

area) and ice. If a participant has pain attend a group exercise program for 1 ing visit, control participants meet with
<6/10, exercises may be modified to hour, 3 times per week for 6 months, the study physical therapist and receive
ensure the ability to complete the exer followed by 6 months of usual physical 1:1 instruction in the kyphosis-specific
cises without increasing pain. activity. Those assigned to the control exercise program, an exercise DVD of
group attend a group education program the study exercise program, handouts
Frequency and d u ratio n . Partici for 1 hour, once a month for 6 months. with pictures of the exercises and con
pants assigned to the intervention group After the 6-month postintervention test cepts of postural alignment, and exercise

37 4 Physical T h e ra p y V o lu m e 96 Num ber 3 M a rch 201 6


equipment (a roller and Thera-lland [The
Hygenic Corp, Akron, Ohio]). The inter
vention group participants receive the
same DVD, handouts, and exercise
equipment after their 6-month testing
visit.
Intensity. The strengthening regimen
incorporates high-intensity strengthen
ing exercise at a Borg scale intensity of 4
to 5, based on 70% to 80% of perceived
exertion,20-21 a stimulus recommended
to produce significant strength gains,
and often results in improved endurance
in the upper and lower extremity mus
cles in older adults.22 For all strengthen
ing exercises (quadruped arm and leg
lift, prone trunk lift, side-lying thoracic
rotation/extension, and side-lying leg
lifts), we implement a gradual, ramped
protocol for the first 6 weeks, beginning
without resistance, while participants
learn the exercises and gradually prog
ress the intensity of the exercise with
Thera-Band or resistance with weights to
light-intensity (30%- 40%), moderate-
intensity (50%-60%), and high-intensity
(70%-80%) resistance based on per
ceived exertion until a Borg scale inten
sity of 4 to 5 is reached.23 24 When exer
cising at a Borg scale intensity of 4 to 5,
within the first 2 repetitions, the partic
ipant typically rates the level of difficulty
as somewhat hard to hard. If the par
ticipant rates the difficulty as less than
somewhat hard, the resistance will be
increased. If the participant rates the
level of difficulty as more than hard,
resistance will be reduced. The goal is to
perform 2 sets of good-quality move
ments in the range of 70% to 80% of
maximum until momentary muscle
fatigue at 8 repetitions.23 24 Weights are
increased from 1 lb, in 1-lb increments,
and Thera-Band resistance is increased,
progressing from yellow to red to green
to blue Thera-Band (corresponding to
2-10 lb of force for each percentage of
Thera-Band strain).25 Resistance is
increased throughout the trial to main
tain a somewhat hard to hard level of
exertion.
Comparator. The control group was
designed to approximate the social inter
action and attention received during the
exercise intervention. Control group par
ticipants receive monthly health educa
March 2016
Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol
tion classes in a group class format to sequences, and study personnel are noti
provide social interaction. Sample topics fied to correct any errors. The data are
include bone health, managing urinary stored and accessible to the data analyst
incontinence, fall prevention, and stress for transfering to SAS software (SAS Insti
management. Additionally, the study tute Inc, Cary, North Carolina) for view
coordinator calls participants on a ing, reporting, and analyses.
monthly basis to record 7 days of pedom
eter reading and to collect safety log Primary O utcom e
information for monitoring adverse The primary outcome is change in
events. kyphosis from baseline to 6 months,
measured using the gold standard Cobb
Blinding. Participants and class angle of kyphosis derived from standing
instructors in this study cannot be lateral spine radiographs and a standard
blinded. However, the primary outcome ized protocol for thoracic kyphosis (T4 -
measurement of change in Cobb angle of T12).26 We will perform exploratory
kyphosis from lateral spine radiographs analyses using the centroid method for
will be made by an investigator blinded measuring Cobb angle from lateral spine
to group allocation. Furthermore, all radiograph and the Debrunner kyphom-
measurements of physical function are eter external measurement of
collected by an investigator blinded to kyphosis.27
group allocation.
Secondary Outcomes
Data Collection and Secondary outcomes are 3-, 6-, and
M an a g e m e n t 12-month changes of physical function
Operating procedures, informed con and health-related quality of life.
sent, scripts for telephone screening and
teaching the exercise intervention, data Physical function. The modified PPT
forms, and checklists for visits are in the
is a composite measure of several aspects
Study of Hyperkyphosis, Exercise and of physical function in aging adults.28
Function (SHEAF) study manual. The The modified PPT includes 7 timed stan
study schedule and the hypotheses and dardized tasks (50-ft [15.2-m] floor walk,
analyses are shown in Tables 2 and 3, putting on and removing a laboratory
respectively. A research assistant/coordi-
coat, picking up a penny from the floor,
nator initially screens participants for the
standing up 5 times from a 40.6-cm-high
study on the telephone or via an online 116-in-high] chair without the use of
screening tool, followed by a telephone arms, lifting a 7-lb book to a shelf, climb
screen. Study staff obtain informed ing one flight of stairs, and standing with
consent and perform an in-person clinic feet together) and 2 additional untimed
screen to ensure that participants meet tasks (climbing up and down 4 flights of
all study criteria. Study staff also collect
stairs and performing a 360 turn). A 4-m
baseline demographic and health infor walk test is administered to measure gait
mation. Once approval to participate is speed (in meters per second).29 The
obtained from the primary care provider, Tinted Up & Go Test measures the time
participants attend a run-in meeting, (in seconds) to rise from a 48-cm-high
where they receive a reference manual armchair, walk 3 m, turn, and return to a
with study contact information, time and fully seated position in the chair.30
location for testing and class visits, and a
Timed loading standing is a test of com
pedometer with instructions to wear for bined trunk and arm endurance that mea
7 days prior to their baseline testing. sures the time (in seconds) a person can
stand while holding a 2-lb dumbbell in
A UCSF Clinical Research Center exer each hand with the arms at 90 degrees of
cise physiologist performs the physical shoulder flexion and the elbows
performance tests. Data are entered via extended.31 The Six-Minute Walk Test is
Research Electronic Data Capture a measure of aerobic capacity and
(REDCap) forms into a secure database. records the distance (in feet) covered
Every' hour, preprogrammed error during walking for 6 minutes.32
checking programs scan incoming forms
for completeness, data ranges, and logic
Volume 96 N um ber 3 Physical Therapy 375
 Table 2.

376
Schedule o f Enrollm ent, Intervention, and Assessments'

T im e P o in t in S tu d y S c hedule

S c re e n in g / R u n -in B aseline S tu d y C lasses/ 3 -m o 6 -m o 1 2 -m o

A c tiv ity S ta ff M e m b e r C onsent P ro c e d u re s T e s tin g Lec tu res T e s tin g T e s tin g T e s tin g 6

R e c r u itm e n t a n d s cre e n in g

X
Telephone prescreening Recruiter

Physical Therapy
X
C linic screening, kyphosis m easurem ent Research assistant

X
C linic screening, g a it speed and safety Research assistant
exam inations

X
C linic screening, d em o g ra ph ic, m edical Research assistant

Volume 96
h istory and M in i-C o g questionnaires

X
Info rm e d consent Research assistant
__________________________________1
A ssessm ents

Number 3
X
X
X

Pedom eter alloca tion /re a d in g s

X
X

Research assistant

X
X

H e ig h t and w e ig h t m easurem ent

X
X

Research exercise p hysiologist

X
M o d ifie d Physical Perform ance Test
X
X
X

Research exercise p hysiologist

X
X

Tim ed loaded standing

X
X

Research exercise p hysiologist

X
X

T im ed "U p & G o " Test

X
X

Research exercise p hysiologist

X
X

6 -M in u te W alk Test
X
X

Research exercise p hysiologist

X
4 -m w alk
X
X
X

Research exercise p hysiologist

X
X

Biodex (isokinetic extension and

X
X

Research exercise physiologist

fle xio n )
Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol

X
X
X

D ebrunner kyphosis and lordosis

X

Research exercise physiologist

X

Lateral spine radiograph

X
X

R adiologist
X

C o m p u te d to m o g ra p h y at L4
X
X

R adiologist
X

DXA h ip and lu m b a r spine Research exercise p hysiologist

X

R andom ization Research assistant

X
X
X

PASE questionnaire
X

Participant
X
X

SRS-30, self-im age d om ain

X
X

Participant
X
X

PROMIS g lo b a l health and physical

X
X

Participant
fu n c tio n indexes

Adverse event p ro to co l Research c o o rd in a to r As needed th ro u g h o u t study

(Continued)

March 2016
 S tudy o f H yperkyphosis, Exercise an d F unction (SHEAF) P ro to co l

Health-related quality of life. We

administer the modified SRS-30 self-
image domain33 to measure self-image
and the PROM IS global health and phys
ical function indexes to measure overall
health and physical function quality of
life.34

Other measures. Questionnaires are

used to collect demographic data and
medical history (eg. current medications
and medical comorbidities in the previ
ous 5 years) at the screening and baseline
study visit. We measure height and
weight using standard methods and bone
density of the hip and spine using GE
Lunar Prodigy (GE Healthcare, Milwau
kee, Wisconsin) dual x-ray absorptiom
etry (DXA) at the baseline visit. We are
using a standardized protocol for spine
muscle flexor and extensor strength,16
with the Biodex 3 (Biodex Medical Sys
tems Inc, Shirley, New York) computer
ized dynamometer and the spine attach
ment to measure peak torque to body
weight muscle strength (RSI Systems,
Boulder, Colorado). We are obtaining
axial images from abdominal quantitative
computed tomography scans at the
L4-L5 disk space (GE9800 Advantage,
GE Healthcare) and calculating spinal
extensor muscle density (Hounsfield
units) using specialized proprietary soft
ware. Vertebral fractures will be calcu
lated from T4-L4 baseline standing lat
eral spine radiographs. Physical activity
level is measured at baseline, 3-month,
6-month, and 12-month study visits using
the Physical Activity Scale for the Elderly
(PASE) questionnaire35 and an Omron
step counter (OMRON Healthcare
Europe BV, Hoofddorp, the Netherlands)
for 7 days. Pain and pain interference
data are collected at each visit.

Harms. Participants are asked to

report adverse events to the study staff.
Safety logs are administered by the study
coordinator on a weekly basis in the
intervention group and monthly in the
control group. Participants complete an
event log documenting change in pain,
falls, and other injuries. Events are cate
gorized as occurring during a study visit,
occurring outside of a study visit, pre
existing, or new event. Serious adverse
events (death, life-threatening adverse
experiences, related inpatient hospital-

March 2016 Volume 96 Number 3 Physical Therapy 377

Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol

Table 3.
Variables, Hypotheses, Outcomes, and Methods of Analysis0

V a ria b le /O u tc o m e H yp othesis O u tc o m e M e as u re M e th o d o f A nalysis

P rim a ry

Kyphosis Improvement in intervention relative to Radiographic Cobb angle ANCOVA

control group
Secondary

Composite physical function Improvement in intervention relative to Modified Physical Performance Test ANCOVA
control group score (7 items)
Gait speed Improvement in intervention relative to 4-m walk test ANCOVA
control group

Mobility Improvement in intervention relative to Timed "Up & Go" Test ANCOVA
control group

Spine endurance Improvement in intervention relative to Timed loaded standing ANCOVA

control group

Aerobic capacity/endurance Improvement in intervention relative to Six-Minute Walk Test ANCOVA

control group

Spinal muscle strength Improvement in intervention relative to Biodex computerized dynamometer ANCOVA
control group

Spinal muscle density Improvement in intervention relative to Spinal extensor muscle attenuation ANCOVA
control group from CT scans (HU)
Spine-specific health-related Improvement in intervention relative to SRS-30 self-esteem domain ANCOVA
quality of life control group

General health-related quality of Improvement in intervention relative to PROMIS global health and physical ANCOVA
life control group function indexes
Kyphosis Improvement in intervention relative to Kyphosis derived from Debrunner ANCOVA
control group kyphometer
O th e r o u tco m e s

Enrollment We will recruit 100 participants Number recruited Descriptive statistics

Retention We will retain at least 75% of the
sample
Adherence Mean proportion of exercise sessions
completed will be 60%
Adverse events No difference between groups
S u b g ro u p o r s e n s itiv ity analyses
Number who completed the study Descriptive statistics
testing visit 2
Mean proportion of completed Estimates based on mean
exercise visits (95% Cl)
Self-report of adverse events Chi-square test

Level of baseline kyphosis (split
at 75th percentile)
Number of comorbidities
Presence or absence of vertebral
fracture on baseline lateral
spine radiographs
No difference in outcomes
No difference in outcomes
No difference in outcomes
=:75th vs < 75 th percentile of kyphosis Variable X treatment group
interaction
^ 2 vs 0-1 comorbidities Variable x treatment group
interaction
>1 or 0 vertebral fractures Variable X treatment group
interaction

Physical activity level at baseline No difference in outcomes Step count at testing visit 1 Variable X treatment group
interaction
Change in physical activity at 6 No difference in outcomes Change in step count from testing visit Variable X treatment group
mo 1 to testing visit 2 interaction

ANCOVA analysis of covariance, CTcomputed tomography, HU Hounsfield unit, SRS-30~modified Scoliosis Research Society instrument,
PROMIS=Patient Reported Outcomes Measurement Information System, CI=confidence interval.

ization) will be reported to the UCSF Recruitment. Participants are cisco Medical Center; flyers posted in the
Committee on Human Subjects Research recruited from community talks at local UCSF Department of Physical Therapy,
within 5 days. senior centers; communication with pri Department of Medicine-Division of
mary care physicians at KPNC San Fran General Internal Medicine, and Orthope-

378 Physical Therapy Volume 96 Number 3 March 2016


dies and Spine Clinic and the San Fran
cisco Veterans Affairs Medical Center
and KPNC San Francisco Medical Center;
and letters sent to people aged 60 years
and older in a UCSF registry of patients
who have previously agreed to be con
tacted about research and a KPNC San
Francisco Medical Center diagnosis-
unspecified database established for the
study.
Strategies to enhance re te n tio n . All
participants are remunerated $100 upon
completion of the study. All participants
also receive a copy of the study exercises
on DVD, an exercise manual with study
concepts and photographs of the exer
cises, a foam roller, and Thera-Band. Par
ticipants in the intervention group
receive up to seventy-two 1-hour group
exercise classes, and participants in the
control group receive four 1-hour health
education meetings and an individual
1-hour session with the study physical
therapist after their 6-month testing visit.
Both groups receive copies of their DXA
and x-ray reports upon completion of the
study. Throughout the study, parking is
reimbursed for study visits, or taxi
vouchers are provided for the testing
visits.
Sam ple size estim ation . We calcu
lated the minimal effects detectable with
80% power in 2-sided tests with a type I
error rate of 5% for a sample size of 100
participants, allowing for within-subject
correlation of the baseline and 6-month
outcomes and loss to follow-up of 20% of
participants. Results shown in Table 4
strongly suggest that the study is pow
ered to detect clinically meaningful
effects.
The minimum detectable effects for
kyphosis and PPT scores shown in Table
4 are consistent with our uncontrolled
pilot study results, even if regression to
the mean and spontaneous improvement
accounted for half of the mean improve
ment of 6 degrees in kyphosis and 2
points in PPT scores. Standard methods
for analysis of covariance, positing reduc
tions in residual variance by a factor of
1 r2 due to adjustment for the baseline
value of the outcome, were used to
obtain these estimates, with r represent
ing the within-subject correlation. Using
March 2016
Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol
T able 4.
Minimum Detectable Effects With Sample Size of 100 Participants
O u tc o m e M e a s u re
Kyphosis ()
M o difie d Physical Performance Test (points)
Gait speed (m /s)
data from the pilot study, w e estimated r
as .8 for kyphosis and PPT and .85 for
gait speed; w e also used pilot data to
obtain residual standard deviations (5,
2.6, and 0.18, respectively).
Analyses
Reporting will be in accordance with
SPIRIT (Standard Protocol Items: Recom
mendations for Interventional Trials)
guidelines. The primary analyses will be
by treatment assignment, without regard
to adherence to the intervention.
Changes in Cobb angle of kyphosis at 6
months will be the primary end point.
Given fiscal and feasibility limitations on
this single-site study, tests of treatment
effects on 6 additional physical function
measures and 3 health-related quality of
life measures (aim 2), as well as muscle
strength and density (aim 3) and all com
parisons at I year, will be regarded as
secondary and analyzed without penalty
for multiple comparisons but with
results clearly presented as hypothesis
generating. We will use t tests and Wil-
coxon, chi-square, and exact tests, as
appropriate, to compare the treatment
and control groups in terms of baseline
age, sex, comorbidities, vertebral frac
tures, degenerative disk disease, and
level of kyphosis. If between-group
imbalances are found, sensitivity' analy
ses will be conducted, adjusting for the
imbalanced covariates. However, the pri
mary analysis will be unadjusted to avoid
inflation of type I error and erosion of
confidence in the results due to model
selection. Analysis of covariance will be
used to assess effects of the intervention
on changes from baseline to 6 months in
the primary and secondary end points.
The models will include fixed effects for
treatment, the baseline value of the out
come, and wave of recruitment. Normal
ity' and equality of variance of the resid
uals will be checked and achieved using
transformation, if necessary. We also will
check for nonlinearity in the effect of
Volume 96
A b s o lu te V a lu e /P e r c e n ta g e
o f M e an C hange
1 .8 8 /3 .3 %
0 .9 8 /3 .3 %
0 .0 5 9 /4 .4 %
baseline value of the outcome and its
interaction with treatment assignment.
In the secondary analysis, the same
approach will be used for changes from
baseline to 1 year. In exploratory sub
group analyses, w e will assess differ
ences in the treatment effect by baseline
kyphosis, split at the 75th percentile;
number of comorbidities (S 2 versus
0-1); and presence of vertebral fracture.
Finally, w e will use the methods of Bland
and Altman to assess the agreement of
radiographic and Debrunner kyphosis
measurements and then assess treatment
effects using the Debrunner measure
ments. After w e assess intervention
effects on muscle strength and density,
w e will use structural equation modeling
to assess the pathways through which
the intervention affects physical
function. We hypothesize that the inter
vention will have direct effects on func
tion and indirect effects on function via
kyphosis, muscle strength, and density;
w e also hypothesize an indirect effect of
the intervention on kyphosis via strength
and density. These analyses will control
for potential confounders of the changes
in kyphosis and strength, including age,
baseline kyphosis severity, degenerative
disk disease, physical function, and ver
tebral fractures.
Trial m o n ito rin g .The principal inves
tigator (W.B.K.) has primary responsibil
ity' for the overall conduct of the study,
the study manual, and chairing study
meetings with the coinvestigators. The
principal investigator and lead investiga
tors meet after each wave of the study to
review the progress of the study and
address any' human subject issues that
occur. These discussions may involve
adverse event prevention measures, par
ticipant accrual issues, research staff
training on protection of human sub
jects, and occurrence of adverse events.
Lead investigators will contribute exper-
Number 3 Physical Therapy 379
S tu d y o f H yperkyphosis, Exercise an d F unction (SHEAF) Protocol
tise in design and analysis and contribute
to overall study progress.
Data Safety M onitoring Board. The
Data Safety Monitoring Plan provides for
an external, objective Data and Safety
Monitoring Board (DSMB) comprising 3
arms length members who review safety
of study participants after each wave of
the study. Blinded safety data are com
municated to all DSMB members. The
DSMB reviews annual reports prepared
by the principal investigator, statistician,
and data management staff on the prog
ress of the project, including data on
enrollment; comparison of target with
actual enrollment; overall status of the
study participants; adherence to the
study interventions; and information on
race and ethnicity, sex, and adverse
events. The DSMB determines whether
the study should continue, be termi
nated, or be modified based on observed
beneficial or adverse effects.
Ethics and C o n fid e n tiality
The study has received approval front
the UCSF and Kaiser Permanente North
ern California institutional review boards
(IRBs) and the Research Committee of
the San Francisco Veterans Affairs Medi
cal Center. Any study modifications are
approved by the IRBs before implemen
tation, consent forms are revised, and the
protocol revisions are reported on the
ClinicalTrials.gov site. Participants for
the current trial are assigned an identifier
to be used on all forms and in the data
base management system. De-identified
data are stored in a secure database and
are backed up daily. Hard copies of
records with personal identifiers are kept
separately from the data. Data are
entered into the data management sys
tem by a research assistant/coordinator.
Only the research assistant/coordinator
and the database service provider are
able to view participants data and iden
tifiers in the database. Trial investigators
have no relevant financial or competing
interests.
Discussion and
Dissem ination
We propose to evaluate the efficacy of a
single-site randomized controlled trial of
a targeted multimodal spine strengthen
ing exercise program in community
380 Physical T h era py V o lu m e 9 6
dwelling adults aged >60 years with
hyperkyphosis. A recent systematic
review of the effects of exercise on
hyperkyphosis supports the need for an
adequately designed RCT examining the
effect of exercise on hyperkyphosis.17
Furthermore, efforts to prevent or treat
osteoporosis-related spinal kyphosis
have identified the need for more com
prehensive assessment of health out
comes in older adults with excessive
kyphosis, including comprehensive
assessment of symptoms, impact, and
treatment benefit for kyphosis.15
The population is aging, although physi
cal function status is not keeping pace.36
Individuals are living longer with greater
impairments in physical mobility. There
is sparse high-quality evidence of the
effects of targeted spine strengthening
exercise on kyphosis. Few trials have
assessed the effects of a multimodal
spine strengthening exercise program on
physical function, specifically mobility
function, which is known to be impaired
in individuals with hyperkyphosis. We
are conducting a high-quality RCT that is
adequately powered and utilizes vali
dated outcome measurements of kypho
sis to investigate the effects of a multi
modal spine strengthening exercise
program on both our primary outcome
of kyphosis and secondary outcomes of
physical function. If the exercise inter
vention results in a change in kyphosis or
physical function, or both, we will exam
ine the pathways of change to determine
whether changes in kyphosis, spinal
muscle strength, or density are responsi
ble for the change in physical function.
Furthermore, if we find that hyperky pho
sis and physical function can be
improved by a hmltimodal spine
strengthening exercise program, this
evidence could enable providers to
recommend early intervention for
hyperkyphosis to prevent or delay
hyperkyphosis-associated physical
disability.
Our study has some limitations, includ
ing that we are recruiting a healthy
community-based group of adults >60
years of age and are excluding individu
als with comorbidities that could inter
fere with safe participation in a group
exercise class. Therefore, the results of
Num ber 3
this study will not be generalizable to
adults with frailty' aged >60 years with
hyperkyphosis. Another limitation is that
blinding the participants and the instruc
tors providing the intervention is not
possible. Although such blinding is not
uncommon in exercise trials, we have
ensured that the investigators measuring
kyphosis and performing the physical
function testing are blinded to group
allocation.
To ensure that the results of our study
will inform physical therapists in prac
tice and have an impact on patient care,
results will be presented at scientific con
ferences and published in academic jour
nals. We also will disseminate the results
of this clinical trial to professional
groups, including the American Physical
Therapy Association, American Society
of Bone and Mineral Research, and
National Osteoporosis Foundation.
These professional organizations may
incorporate findings from this research
into evidence-based exercise prescrip
tions and clinical practice guidelines for
older adults with hyperkyphosis.
Our goal is to conduct a clinical trial that
will provide clinicians with evidence of
the efficacy of a targeted multimodal
spine strengthening exercise program on
hyperkyphosis and physical function.
Exercise trials have often used lower
extremity strengthening exercise to
improve physical functlbn in older
adults. In contrast, we are focusing on
decreasing spinal hyperkyphosis. If our
exercise intervention is successful, our
approach to improving hyperkyphosis
could represent a fundamental paradigm
shift in exercise intervention strategies
to improve physical function for older
adults. Results from our trial may provide
new insights into the effects of exercise
on physical function and quality of life
that are important outcomes for patients
and, if successful, could assist providers
in individualized clinical decision
making.
D r K atzm an con ceived th e stud y. D r Katz
m an, D r V ittin g h o ff, D r Kado, and D r Lane
in itia te d th e stu d y design, and D r Lane, D r
Schafer, M s W o n g , and D r G lad in he lp ed
w ith im p le m e n ta tio n . D r K atzm an is th e
g ra n t h o ld e r. D r V ittin g h o ff p ro v id e d statis-
M a rc h 2 0 1 6

tical expertise in clinical trial design and con
ducted the primary statistical analysis. All
authors contributed to refinement of the
study protocol and approved the final man
uscript. The authors appreciate Dr Roger
Long's oversight reviewing participant med
ical histories and safety logs.
The study was funded by National Institute
of Aging grant R01-AG028. Additional sup
port was provided by the US Department of
Veterans Affairs, Veterans Health Administra
tion, Office of Clinical Science Research and
Development, under grant 5 IK2 CX000549
(to Dr Schafer).
ClinicalTrials.gov Identifier: NCT01751685
(issue date: December 3, 2012; protocol
amendment number: 05; author: Ms
Wong).
DOI: 10.2522/ptj.201 501 71
References
1 Takahashi T, Ishida K, Hirose D, et al.
Trunk deformity is associated with a
reduction in outdoor activites of daily liv
ing and life satisfaction in community-
dwelling older people. Osteoporos Int.
2005;16:273-279.
2 Kado DM, Huang MH, Karlamangla AS,
et al. Hyperkyphotic posture predicts mor
tality in older community-dwelling men
and women: a prospective study. J Am
Geriatr Soc. 2004;52:1662-1667.
3 Katzman WB, Cawthon P. Hicks GE, et al.
Association of spinal muscle composition
and prevalence of hyperkyphosis in
healthy community-dwelling older men
and w omen./ Gerontol A Biol Sci Med Sci.
2012;67:191-195.
4 Kado DM. Huang MH. Barrett-Connor E,
Greendale GA. Hyperkyphotic posture and
poor physical functional ability in older
community-dwelling men and women: the
Rancho Bernardo study. J Gerontol A Biol
Sci Med Sci. 2005;60:633-637.
5 Kado DM, Huang MH, Nguyen CB, et al.
Hyperkyphotic posture and risk of injuri
ous falls in older persons: the Rancho Ber
nardo Study./ Gerontol A Bio! Sci Med Sci.
2007;62:652-657.
6 Katzman WB, Harrison SL, Fink HA, et al.
Physical function in older men with hyper
kyphosis. / Gerontol A Biol Sci Med Sci.
2015;70:635-640.
7 Katzman WB, Huang MH, Lane NE, et al.
Kyphosis and decline in physical function
over 15 years in older community-dwelling
women: the study of osteoporotic frac
tures. / Gerontol A Biol Sci Med Sci. 2013;
68:976-983.
8 Huang Mil, Barrett-Connor E, Greendale
GA, Kado DM. Hyperkyphotic posture and
risk of future osteoporotic fractures: the
Rancho Bernardo study. / Bone Miner lies.
2006:21:419-423.
March 2016
Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol
9 Kado DM, Huang MI1, Karlamangla AS,
et al. Factors associated with kyphosis
progression in older women: 15 years'
experience in the study of osteoporotic
fractures. / Bone Miner Res. 2013:28:179-
187.
10 Ensrud KE. Black DM, Harris F, et al; for
the Fracture Intervention Trial Research
Group. Correlates of kyphosis in older
women:. J Am Geriatr Soc. 1997;45:682-
687.
11 Ettinger B, Black DM, Palermo I., et al.
Kyphosis in older women and its relation
to back pain, disability and osteopenia: the
study of osteoporotic fractures. Osteopo
ros int. 1994;4:55-60.
12 Hongo M, Miyakoshi N. Shimada Y, Sinaki
M. Association of spinal curve deformity
and back extensor strength in elderly
women with osteoporosis in Japan and the
United States. Osteoporos Int. 2012;23:
1029-1034.
13 Sinaki M, Itoi E, Rogers JW, et al. Correla
tion of back extensor strength with tho
racic kyphosis and lumbar lordosis in
estrogen-deficient women. Am JPhysMed
Rehabil. 1996;75:370-374.
14 Hinman MR. Comparison of thoracic
kyphosis and postural stiffness in younger
and older women. Spine J. 2004;4:413-
417.
15 Bayliss M, Miltenburger C, White M. Alva-
res L. A conceptual and disease model
framework for osteoporotic kyphosis.
Osteoporos Int. 2013;24:2423-2432.
16 Katzman WB, Sellmeyer DE, Stewart AL,
et al. Changes in flexed posture, musculo
skeletal impairments, and physical perfor
mance after group exercise in community
dwelling older women. Arch Phys Med
Rehabil. 2007;88:192-199.
17 Bansal S, Katzman WB, Giangregorio LM.
Exercise for improving age-related hyper
kyphotic posture: a systematic review.
Arch Phys Med Rehabil. 2014;95:129-
140.
18 Pfeifer M, Begerow B, Minne HW. Effects
of a new spinal orthosis on posture, trunk
strength, and quality of life in women with
postmenopausal osteoporosis: a random
ized trial. Am / Phys Med Rehabil. 2004;
83:177-186.
19 Borson S, Scanlan JM, Chen P, Ganguli M.
The Mini-Cog as a screen for dementia:
validation in a population-based sample.
J Am Geriatr Soc. 2003;51:1451 -1454.
20 Gearhart RF Jr, Goss FL, Lagally KM, et al.
Ratings of perceived exertion in active
muscle during high-intensity and low-
intensity resistance exercise. / Strength
Cond Res. 2002;16:87-91.
21 Day ML, McGuigan MR, Brice G, Foster C.
Monitoring exercise intensity during resis
tance training using the session RPE scale.
J Strength Cond Res. 2004;18:353-358.
22 Singh MA. Exercise comes of age: rationale
and recommendations for a geriatric exer
cise prescription. / Gerontol A Biol Sci
Med Sci. 2002;57:M262-M282.
Volume 96
23 Feigenbaum MS, Pollock ML. Strength
training: rationale for current guidelines
for adult fitness programs. Phys
Sportsmed. 1997;25:44-63.
24 Pollock ML, Wenger NK. Physical activity
and exercise training in the elderly: a posi
tion paper from the Society of Geriatric
Cardiology. Am J Geriatr Cardiol. 1998;7:
45-46.
25 Patterson RM, Stegink Jansen CW, Hogan
HA, Nassif MD. Material properties of
Thera-Band tubing. Phys 7her. 2001 ;81:
1437-1445.
26 I.undon KM, Li AM, Bibershtein S. Interra
ter and intrarater reliability in the measure
ment of kyphosis in postmenopausal
women with osteoporosis. Spine (Phila
Pa 1976). 1998;23:1978-1985.
27 Briggs AM, Wrigley TV, Tull)' EA, et al.
Radiographic measures of thoracic kypho
sis in osteoporosis: Cobb and vertebral
centroid angles. Skeletal Radiol. 2007:36:
761-767.
28 Reuben DB, Siu AL. An objective measure
of physical function of elderly outpatients:
the Physical Performance Test. / Am Geri
atr Soc. 1990;38:1105-1112.
29 Studenski S, Perera S, Wallace D, et al.
Physical performance measures in the clin
ical setting. / Am Geriatr Soc. 2003:51:
314-322.
30 Podsiadlo D. Richardson S. The timed Up
& Go: a test of basic functional mobility
for frail elderly persons. / Am Geriatr Soc.
1991;39:142-148.
31 Shipp KM, Purse JL, Gold DT, et al. Timed
loaded standing: a measure of combined
trunk and arm endurance suitable for peo
ple with vertebral osteoporosis. OsteoJlo
ros/nt. 2000; 11:914-922.
32 ATS Committee on Proficiency Standards
for Clinical Pulmonary Function Laborato
ries. ATS statement: guidelines for the six-
minute walk test. Am / Respir C.rit Care
Med. 2002;166:111-117.
33 Asher MA, Min Lai S, Burton DC. Further
development and validation of the Scolio
sis Research Society (SRS) outcomes
instrument. Spine (Phila Pa 1976). 2000;
25:2381-2386.
34 Gershon RC, Rothrock N, Hanrahan R,
et al. The use of PROMIS and assessment
center to deliver patient-reported out
come measures in clinical research. JAppl
Meas. 2010;11:304-314.
35 Washburn I1A, Smith KW, Jette AM, Janney
CA. The Physical Activity Scale for the
Elderly (PASE): development and evalua
tio n ./ Clin Epidemiol. 1993;46:153-162.
36 Crimmins EM, Beltran-Sanchez H. Mortal
ity and morbidity trends: is there compres
sion of morbidity?/ Gerontol B Psychol Sci
Soc Sci. 2011;66:75-86.
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