- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01751685
Study of Hyperkyphosis, Exercise and Function-SHEAF (sheaf)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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California
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San Francisco, California, United States, 94143
- UCSF
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 60 years and older, kyphosis angle >= 40 degrees measured by kyphometer, medical approval from study physician and primary care provider to participate in exercise intervention
Exclusion Criteria:
- Gait speed <0.6 meters/sec, inability to rise from a chair with arms crossed at chest, painful vertebral fractures in the past 3 months, 3 or more falls in the past year, advanced disability or end-stage disease, major psychiatric illness, cognitive impairment, alcohol, drug abuse, or narcotic pain medications, uncontrolled hypertension, peripheral neuropathy associated with type I diabetes, chest pain, myocardial infarction, or cardiac surgery within the previous 6 months, diagnosed vestibular or neurologic disorder, total hip or knee replacement or hip fracture within previous 6 months, oral glucocorticoid medications for ≥ 3 months the past year, no active movement in thoracic spine, unable to execute exercise safety tests, failure to comply with run-in procedures: poor attendance, or use of actigraph, non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kyphosis-specific spinal exercises
Investigator developed the intervention protocol (Kyphosis-specific spinal exercises) of targeted spine exercises during our pilot study based upon the literature and clinical experience.We standardized the protocol with a written script and a video.
Each exercise session will be preceded by light aerobic activity, ended with cool-down and stretching the neck, chest and all extremities.
All participants will be carefully monitored to ensure that all exercises will be performed slowly, with correct body alignment and technique to minimize risk of injury.
|
Investigator developed the intervention protocol (Kyphosis-specific spinal strengthening exercises) of targeted spine exercises during our pilot study based upon the literature and clinical experience.We standardized the protocol with a written script and a video.
Each exercise session will be preceded by light aerobic activity, ended with cool-down and stretching the neck, chest and all extremities.
All participants will be carefully monitored to ensure that all exercises will be performed slowly, with correct body alignment and technique to minimize risk of injury.
|
Placebo Comparator: Control
Usual care control group will meet once a month for educational lectures on various topics.
At the end of 6 months, each control group participant will get a one-on-one session with the physical therapist who was leading the intervention classes.
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monthly educational lectures on various topics
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cobb Angle of Kyphosis
Time Frame: Baseline and 6 months
|
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).
The study team performed exploratory analyses using the centroid method for measuring Cobb angle from lateral spine radiograph and the Debrunner kyphometer external measurement of kyphosis.
Participants stood barefoot with knees straight and arms supported at 90° of flexion; they were instructed to hold full inhalation for the duration of the scan.
Measurements were made by a trained radiologist (BF) who read the radiographs paired by participant but blinded to group allocation.
A greater Cobb angle indicates more kyphosis severity.
|
Baseline and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Modified Physical Performance Test (PPT)
Time Frame: Baseline and 6 months
|
Modified Physical Performance Test (PPT) is a composite measure of physical function in aging adults: 50ft [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 40.6cm-high [16in-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). The test involves 9 functional items, 4 points per item; the range is 0-36 points, and higher values represent a higher physical performance. |
Baseline and 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Exercise Intervention on Kyphosis
Time Frame: 1 year post baseline
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Investigators will measure change in Cobb angle on lateral spine radiograph.
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1 year post baseline
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Effect of Exercise Intervention on Secondary Measure of Physical Function
Time Frame: 1-year post baseline
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Investigators will measure change in physical function with Modified Physical Performance Test (PPT), gait speed, Timed Up and Go, Timed Loaded Standing, 6 minute walk and spinal extensor muscle strength.
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1-year post baseline
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Effect of Exercise Intervention on Health Related Quality of Life (HRQOL)
Time Frame: 6 month post baseline
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Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires.
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6 month post baseline
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Effect of Exercise Intervention on Health Related Quality of Life (HRQOL)
Time Frame: 1 year post baseline
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Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires.
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1 year post baseline
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Effect of Exercise Intervention on Muscle Strength
Time Frame: 6 month post baseline
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Investigators will measure change in spinal muscle strength as measured with a Biodex computerized dynamometer, and spinal muscle density as measured with quantitative computed tomography.
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6 month post baseline
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Katzman WB, Vittinghoff E, Kado DM, Schafer AL, Wong SS, Gladin A, Lane NE. Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol of a Randomized Controlled Trial of Multimodal Spine-Strengthening Exercise in Older Adults With Hyperkyphosis. Phys Ther. 2016 Mar;96(3):371-81. doi: 10.2522/ptj.20150171. Epub 2015 Aug 6.
- Katzman WB, Vittinghoff E, Lin F, Schafer A, Long RK, Wong S, Gladin A, Fan B, Allaire B, Kado DM, Lane NE. Targeted spine strengthening exercise and posture training program to reduce hyperkyphosis in older adults: results from the study of hyperkyphosis, exercise, and function (SHEAF) randomized controlled trial. Osteoporos Int. 2017 Oct;28(10):2831-2841. doi: 10.1007/s00198-017-4109-x. Epub 2017 Jul 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P0046955
- R01AG041921-05 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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