Abstract
Background Hyperkyphosis negatively affects health status, physical mobility, and quality of life, but there is no standard protocol for treating people with hyperkyphosis. Treatment options include targeted exercise.
Objectives This single-site randomized controlled trial (RCT) will determine the efficacy of a targeted multimodal spine-strengthening exercise program, compared with no exercise intervention, among community-dwelling men and women aged ≥60 years.
Design The RCT is a parallel-group design, with 1:1 randomization to exercise and attentional control groups.
Setting The study will be conducted at one primary site (one academic medical center partnered with one local community medical center).
Participants One hundred men and women, aged ≥60 years, with thoracic kyphosis ≥40 degrees will be randomized.
Intervention The targeted multimodal spine-strengthening exercise intervention includes exercise and postural training delivered by a physical therapist in a group of 10 participants, 3 times a week for 6 months. Controls receive monthly health education meetings in a group of 10 participants and monthly calls from the study coordinator to monitor physical activity and any adverse events.
Measurements The primary outcome is change in Cobb angle of kyphosis measured from lateral spine radiographs at baseline and 6 months. Secondary outcomes include change 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 life (assessed with the modified Scoliosis Research Society instrument [SRS-30] self-image domain and Patient Reported Outcomes Measurement Information System [PROMIS] global health and physical function indexes). Additional secondary outcomes include pain, physical activity level, spinal flexion and extension muscle strength, paraspinal extensor muscle density, and adverse events.
Limitations Blinding of the participants and instructors providing the intervention is not possible.
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 multimodal spine-strengthening exercise reduces hyperkyphosis in older adults and improves important secondary outcomes of physical function and health-related quality of life.
Age-related hyperkyphosis, an abnormal forward curvature in the thoracic spine, is a common progressive deformity of the spine that affects up to 50% of older adults.1–3 Hyperkyphosis can lead to significant deterioration in health status, physical mobility, and quality of life. Women with hyperkyphosis have slower walking speeds; difficulty climbing stairs; impaired balance; and greater risk for falls, fractures, and mortality.2,4–8 Risk factors for hyperkyphosis include advanced age, low bone mass, degenerative disk disease, and prevalent vertebral fractures.9–11 Routine poor posture, decreased spinal extension mobility, and reduced back extensor muscle strength are other commonly cited potential causes of age-related hyperkyphosis,12–14 and these impairments may be modifiable with exercise.
Despite the adverse effects on health, physical function, and quality of life, hyperkyphosis has only recently started to be recognized by health care providers as a major health concern.15 There is no standard of care for treating hyperkyphosis. Current treatment options include exercise and bracing. We conducted an uncontrolled pilot study of an exercise program targeting spinal muscle strength among older women with hyperkyphosis that resulted in significant improvements in kyphosis, spinal muscle strength, and physical performance.16 A recent systematic review, including 7 randomized controlled trials (RCTs) to determine the effects of exercise on kyphosis, showed that exercise targeting back extensor muscle strength may result in a modest improvement in kyphosis.17 However, a clear recommendation for a treatment intervention was not possible due to the small sample sizes, heterogeneity of the study participants, and different and nonvalidated measurements of the outcome variable of kyphosis. There is a need to perform a high-quality RCT that is adequately powered and uses validated outcome measurements of kyphosis to determine whether targeted spine strengthening reduces hyperkyphosis in older adults. Furthermore, few of the prior studies included outcome measures of physical function, and it is not known whether exercises designed to reduce kyphosis will lead to improvement in physical function. Spinal orthoses reportedly reduce excessive kyphosis and improve spinal extensor muscle strength and physical performance, although they have only been tested in women with underlying spinal osteoporosis.18
Based on the results of our previous pilot study, we designed an adequately powered, high-quality RCT to test the hypothesis that a targeted multimodal spine-strengthening exercise program will lead to a clinically meaningful change in kyphosis in community-dwelling adults with hyperkyphosis aged ≥60 years. The rationale underlying such an intervention is that hyperkyphosis increases with age, contributes to impaired physical function, and will be improved by an exercise intervention targeting musculoskeletal impairments associated with hyperkyphosis.
We are conducting a single-blinded RCT of a multimodal spine-strengthening exercise intervention: (1) to determine if the exercise intervention improves kyphosis, measured as Cobb angle using lateral spine radiographs; (2) to determine if the exercise intervention improves secondary outcome measures of physical function and health-related quality of life, measured using the modified Physical Performance Test (modified PPT), gait speed, Timed “Up & Go” Test, timed loaded standing, modified Scoliosis Research Society (SRS-30) instrument self-image domain, and Patient Reported Outcomes Measurement Information System (PROMIS) global health and physical function indexes; and (3) to determine if the exercise intervention improves spinal muscle strength or spinal muscle density, or both, and if change in these factors is associated with change in physical function.
Method
Study Setting
The study is conducted at the University of California San Francisco (UCSF), an academic medical center, with a second intervention location at the Kaiser Permanente Northern California (KPNC) San Francisco Medical Center.
Trial Design
This is a single-blinded RCT comparing a 3-times-per-week group exercise intervention with a monthly health education group class (ClinicalTrials.gov Identifier NCT01751685) with a 1:1 allocation ratio. Five waves of 20 participants are enrolled in the study, with 10 participants randomized to the intervention group and 10 participants randomized to the control group in each wave (Figure). Participants are randomized in equal proportions to intervention and control groups using randomly permuted blocks of 2 and 4, stratified by age and sex. Treatment assignments are generated prior to the study and placed in order in sealed, opaque envelopes with stratum-specific sequential ID numbers. Consenting participants fulfilling study eligibility criteria are assigned the next available ID number for the appropriate age and sex stratum by the study staff. The envelope is opened at the end of their baseline study visit. The date and time each envelope is opened are recorded in a log along with participant ID to ensure integrity of the randomization.
Flowchart of the randomized controlled trial. PPT=Physical Performance Test, SRS-30=modified Scoliosis Research Society instrument, PROMIS=Patient Reported Outcomes Measurement Information System, CT=computed tomography. Asterisk indicates 12 months for intervention group only (excluding CT).
Participants
Individuals are eligible who are age 60 years and older with kyphosis angle ≥40 degrees, as measured with the Debrunner kyphometer (Techmedica Inc, Camarillo, California). After meeting preliminary study criteria, a study physician reviews each participant's medical history, and a letter is sent to his or her primary care provider for signed approval to participate in the planned exercise intervention. Exclusion criteria include inability to extend the thoracic spine at least 5 degrees, failure to adhere to run-in procedures, non-English speaking, and a disorder or disease likely to prevent or interfere with safe participation in a group-based exercise class, including painful vertebral fractures in the previous 3 months, unexplained weight loss >10 lb [1 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 progressive neurologic disorder, total hip or knee replacement or hip fracture within the previous 6 months, or oral glucocorticoid 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 inability to move from standing to supine on a mat and return to standing independently or with the use of a nearby chair).
Intervention
The intervention is a multimodal, group-based, kyphosis-specific exercise program 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 hyperkyphosis, including spinal extensor muscle weakness, decreased spinal mobility, and poor postural alignment (Tab. 1). The spinal strengthening component incorporates high-intensity strengthening exercise targeted to strengthen spinal extensor muscles and stabilize the trunk in neutral alignment. The spinal mobility component incorporates foam rollers and end-range exercises to increase spinal extension and rotation and reduce mobility limitations in the anterior shoulders, 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 alignment component integrates spinal extensor strength and mobility into practice. The instructor trains participants to recognize neutral spinal alignment and maintain their best spinal alignment during the group exercise program and during 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.
Multimodal Spine Strengthening Exercise Intervention Framework
We standardized the protocol with a written pamphlet/script and a video (see video below). Each exercise session begins with 10 minutes of warm-up activity and ends with 5 minutes of cool-down and stretching of the neck, chest, and all extremities. A licensed physical therapist teaches the intervention. A research assistant is present during exercise class to assist the physical therapist.
Selected exercises used in the intervention.
Setting and supervision.
A group-based intervention led by a physical therapist is implemented to ensure that participants learn from a professional skilled at exercise instruction in an older population with multiple medical comorbidities. 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 area) and ice. If a participant has pain <6/10, exercises may be modified to ensure the ability to complete the exercises without increasing pain.
Frequency and duration.
Participants assigned to the intervention group attend a group exercise program for 1 hour, 3 times per week for 6 months, followed by 6 months of usual physical activity. Those assigned to the control group attend a group education program for 1 hour, once a month for 6 months. After the 6-month postintervention testing visit, control participants meet with the study physical therapist and receive 1:1 instruction in the kyphosis-specific exercise program, an exercise DVD of the study exercise program, handouts with pictures of the exercises and concepts of postural alignment, and exercise equipment (a roller and Thera-Band [The Hygenic Corp, Akron, Ohio]). The intervention group participants receive the same DVD, handouts, and exercise equipment after their 6-month testing visit.
Intensity.
The strengthening regimen incorporates high-intensity strengthening 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 muscles in older adults.22 For all strengthening 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 progress 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 perceived exertion until a Borg scale intensity of 4 to 5 is reached.23,24 When exercising at a Borg scale intensity of 4 to 5, within the first 2 repetitions, the participant typically rates the level of difficulty as “somewhat hard” to “hard.” If the participant 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 movements 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 maintain a “somewhat hard” to “hard” level of exertion.
Comparator.
The control group was designed to approximate the social interaction and attention received during the exercise intervention. Control group participants receive monthly health education classes in a group class format to provide social interaction. Sample topics include bone health, managing urinary incontinence, fall prevention, and stress management. Additionally, the study coordinator calls participants on a monthly basis to record 7 days of pedometer reading and to collect safety log information for monitoring adverse events.
Blinding.
Participants and class instructors in this study cannot be blinded. However, the primary outcome measurement of change in Cobb angle of kyphosis from lateral spine radiographs will be made by an investigator blinded to group allocation. Furthermore, all measurements of physical function are collected by an investigator blinded to group allocation.
Data Collection and Management
Operating procedures, informed consent, scripts for telephone screening and teaching the exercise intervention, data forms, and checklists for visits are in the Study of Hyperkyphosis, Exercise and Function (SHEAF) study manual. The study schedule and the hypotheses and analyses are shown in Tables 2 and 3, respectively. A research assistant/coordinator initially screens participants for the study on the telephone or via an online screening tool, followed by a telephone screen. Study staff obtain informed consent and perform an in-person clinic screen to ensure that participants meet all study criteria. Study staff also collect baseline demographic and health information. Once approval to participate is obtained from the primary care provider, participants attend a run-in meeting, where they receive a reference manual with study contact information, time and location for testing and class visits, and a pedometer with instructions to wear for 7 days prior to their baseline testing.
Schedule of Enrollment, Intervention, and Assessmentsa
Variables, Hypotheses, Outcomes, and Methods of Analysisa
A UCSF Clinical Research Center exercise physiologist performs the physical performance tests. Data are entered via Research Electronic Data Capture (REDCap) forms into a secure database. Every hour, preprogrammed error-checking programs scan incoming forms for completeness, data ranges, and logic sequences, and study personnel are notified to correct any errors. The data are stored and accessible to the data analyst for transfering to SAS software (SAS Institute Inc, Cary, North Carolina) for viewing, reporting, and analyses.
Primary Outcome
The primary outcome is change in kyphosis from baseline to 6 months, measured using the gold standard Cobb angle of kyphosis derived from standing lateral spine radiographs and a standardized protocol for thoracic kyphosis (T4–T12).26 We will perform exploratory analyses using the centroid method for measuring Cobb angle from lateral spine radiograph and the Debrunner kyphometer external measurement of kyphosis.27
Secondary Outcomes
Secondary outcomes are 3-, 6-, and 12-month changes of physical function and health-related quality of life.
Physical function.
The modified PPT is a composite measure of several aspects of physical function in aging adults.28 The modified PPT includes 7 timed standardized tasks (50-ft [15.2-m] floor walk, putting on and removing a laboratory coat, picking up a penny from the floor, standing up 5 times from a 40.6-cm-high [16-in-high] chair without the use of arms, lifting a 7-lb book to a shelf, climbing one flight of stairs, and standing with feet together) and 2 additional untimed tasks (climbing up and down 4 flights of stairs and performing a 360° turn). A 4-m walk test is administered to measure gait speed (in meters per second).29 The Timed “Up & Go” Test measures the time (in seconds) to rise from a 48-cm-high armchair, walk 3 m, turn, and return to a fully seated position in the chair.30 Timed loading standing is a test of combined trunk and arm endurance that measures the time (in seconds) a person can stand while holding a 2-lb dumbbell in each hand with the arms at 90 degrees of shoulder flexion and the elbows extended.31 The Six-Minute Walk Test is a measure of aerobic capacity and records the distance (in feet) covered during walking for 6 minutes.32
Health-related quality of life.
We administer the modified SRS-30 self-image domain33 to measure self-image and the PROMIS global health and physical 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 previous 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, Milwaukee, Wisconsin) dual x-ray absorptiometry (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 Systems Inc, Shirley, New York) computerized dynamometer and the spine attachment 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 software. Vertebral fractures will be calculated from T4–L4 baseline standing lateral 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 categorized 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 hospitalization) will be reported to the UCSF Committee on Human Subjects Research within 5 days.
Recruitment.
Participants are recruited from community talks at local senior centers; communication with primary care physicians at KPNC San Francisco Medical Center; flyers posted in the UCSF Department of Physical Therapy, Department of Medicine–Division of General Internal Medicine, and Orthopedics and Spine Clinic and the San Francisco 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 contacted about research and a KPNC San Francisco Medical Center diagnosis-unspecified database established for the study.
Strategies to enhance retention.
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 exercises, a foam roller, and Thera-Band. Participants 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.
Sample size estimation.
We calculated 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 powered to detect clinically meaningful effects.
Minimum Detectable Effects With Sample Size of 100 Participants
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 improvement of 6 degrees in kyphosis and 2 points in PPT scores. Standard methods for analysis of covariance, positing reductions 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 representing the within-subject correlation. Using data from the pilot study, we estimated r as .8 for kyphosis and PPT and .85 for gait speed; we 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: Recommendations 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 comparisons at 1 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 Wilcoxon, chi-square, and exact tests, as appropriate, to compare the treatment and control groups in terms of baseline age, sex, comorbidities, vertebral fractures, degenerative disk disease, and level of kyphosis. If between-group imbalances are found, sensitivity analyses will be conducted, adjusting for the imbalanced covariates. However, the primary 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 outcome, and wave of recruitment. Normality and equality of variance of the residuals will be checked and achieved using transformation, if necessary. We also will check for nonlinearity in the effect of 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 subgroup analyses, we will assess differences in the treatment effect by baseline kyphosis, split at the 75th percentile; number of comorbidities (≥2 versus 0–1); and presence of vertebral fracture. Finally, we 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 measurements. After we assess intervention effects on muscle strength and density, we will use structural equation modeling to assess the pathways through which the intervention affects physical function. We hypothesize that the intervention will have direct effects on function and indirect effects on function via kyphosis, muscle strength, and density; we 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 vertebral fractures.
Trial monitoring.
The principal investigator (W.B.K.) has primary responsibility for the overall conduct of the study, the study manual, and chairing study meetings with the coinvestigators. The principal investigator and lead investigators 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, participant accrual issues, research staff training on protection of human subjects, and occurrence of adverse events. Lead investigators will contribute expertise in design and analysis and contribute to overall study progress.
Data Safety Monitoring Board.
The Data Safety Monitoring Plan provides for an external, objective Data and Safety Monitoring Board (DSMB) comprising 3 arm's length members who review safety of study participants after each wave of the study. Blinded safety data are communicated to all DSMB members. The DSMB reviews annual reports prepared by the principal investigator, statistician, and data management staff on the progress 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 terminated, or be modified based on observed beneficial or adverse effects.
Ethics and Confidentiality
The study has received approval from the UCSF and Kaiser Permanente Northern California institutional review boards (IRBs) and the Research Committee of the San Francisco Veterans Affairs Medical Center. Any study modifications are approved by the IRBs before implementation, 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 database 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 system by a research assistant/coordinator. Only the research assistant/coordinator and the database service provider are able to view participants' data and identifiers in the database. Trial investigators have no relevant financial or competing interests.
Discussion and Dissemination
We propose to evaluate the efficacy of a single-site randomized controlled trial of a targeted multimodal spine strengthening exercise program in community-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 comprehensive assessment of health outcomes in older adults with excessive kyphosis, including comprehensive assessment of symptoms, impact, and treatment benefit for kyphosis.15
The population is aging, although physical 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 validated outcome measurements of kyphosis to investigate the effects of a multimodal spine strengthening exercise program on both our primary outcome of kyphosis and secondary outcomes of physical function. If the exercise intervention results in a change in kyphosis or physical function, or both, we will examine the pathways of change to determine whether changes in kyphosis, spinal muscle strength, or density are responsible for the change in physical function. Furthermore, if we find that hyperkyphosis and physical function can be improved by a multimodal 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, including that we are recruiting a healthy community-based group of adults ≥60 years of age and are excluding individuals with comorbidities that could interfere with safe participation in a group exercise class. Therefore, the results of this study will not be generalizable to adults with frailty aged ≥60 years with hyperkyphosis. Another limitation is that blinding the participants and the instructors 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 practice and have an impact on patient care, results will be presented at scientific conferences and published in academic journals. 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 prescriptions 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 function 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.
Footnotes
Dr Katzman conceived the study. Dr Katzman, Dr Vittinghoff, Dr Kado, and Dr Lane initiated the study design, and Dr Lane, Dr Schafer, Ms Wong, and Dr Gladin helped with implementation. Dr Katzman is the grant holder. Dr Vittinghoff provided statistical expertise in clinical trial design and conducted the primary statistical analysis. All authors contributed to refinement of the study protocol and approved the final manuscript. The authors appreciate Dr Roger Long's oversight reviewing participant medical histories and safety logs.
The study was funded by National Institute of Aging grant R01-AG028. Additional support was provided by the US Department of Veterans Affairs, Veterans Health Administration, 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).
- Received March 25, 2015.
- Accepted August 2, 2015.
- © 2016 American Physical Therapy Association
References
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