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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG041921-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Aging (NIA) | NIH |
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We propose to conduct a randomized, controlled trial among 100 men and women aged 60 or older with hyperkyphosis to an exercise intervention that includes kyphosis-specific spinal muscle strengthening exercises compared to a usual care control group. The study will be conducted in five waves,with 10 participants in the exercise intervention and 10 participants in the control group in each wave.
The experimental interventions will be provided in small groups meeting three sessions per week for 6 months. At baseline and 6 months after the intervention, we will measure kyphosis, physical function, spine muscle strength and density, and quality of life. We will assess the effect of the intervention on the co-primary outcomes of kyphosis, modified Physical Performance Test (PPT) and gait speed measured as change over 6 months. We will also assess the effect of the intervention on secondary outcomes of physical function and health-related quality of life, measured as change in Timed Up and Go, Timed Loaded Standing, Six-Minute Timed Walk, the Scoliosis Research Society SRS-30, PROMISe Global Health and physical function and PACE questionnaires. Furthermore, we will investigate whether changes in kyphosis, spinal muscle strength and/or density mediate the effect of the intervention on change in physical function. After the 6-month intervention, both groups will continue their usual activity and we will assess the durability of the effects of the intervention at 1-year follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kyphosis-specific spinal exercises | Experimental | 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. |
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| Control | Placebo Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kyphosis-specific spinal strengthening exercises | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cobb Angle of Kyphosis | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Physical Performance Test (PPT) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Exercise Intervention on Kyphosis | Investigators will measure change in Cobb angle on lateral spine radiograph. | 1 year post baseline |
| Effect of Exercise Intervention on Secondary Measure of Physical Function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy B Katzman, DPTSc | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26251480 | Background | 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. | |
| 28689306 | Result | 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. |
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Speaks English, age ≥60 years, kyphosis angle ≥40° by the Debrunner kyphometer measured at the screening visit, and ability to walk one block without the use of an assistive device, climb one flight of stairs independently, and rise from a chair without the use of one's arms. Participants were excluded for inability to straighten the thoracic spine at least 5°, cognitive impairment, inability to pass safety tests in screening or any disorder or disease likely to interfere with safe participation
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Kyphosis-specific spinal strengthening exercises: 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. |
| FG001 | 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. Control: monthly educational lectures on various topics |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6-mo Followup |
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| 12-mo Followup |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Kyphosis-specific spinal strengthening exercises: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Cobb Angle of Kyphosis | 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. | Posted | Mean | 95% Confidence Interval | Degrees | Baseline and 6 months |
|
1 year
Participants are asked to report adverse events to the study staff. Serious adverse events (death, life-threatening adverse experiences, related inpatient hospitalization) will be reported to the University of California, San Francisco Committee on Human Subjects Research in 5 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Kyphosis-specific spinal strengthening exercises: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Falls | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
A healthy community-based group of adults ≥60 years of age were recruited and individuals with comorbidities that could interfere with safe participation in a group exercise class were excluded. Blinding the participants and the instructors providing the intervention is not possible. Although such blinding is not uncommon in exercise trials, it was ensured that the investigators measuring kyphosis and performing the physical function testing are blinded to group allocation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Katzman, PT | University of California, San Francisco | 415-353-7598 | Wendy.Katzman@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 3, 2012 | Jan 17, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D007738 | Kyphosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Control | Other | monthly educational lectures on various topics |
|
| Baseline and 6 months |
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.
| 1-year post baseline |
| Effect of Exercise Intervention on Health Related Quality of Life (HRQOL) | Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires. | 6 month post baseline |
| Effect of Exercise Intervention on Health Related Quality of Life (HRQOL) | Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires. | 1 year post baseline |
| Effect of Exercise Intervention on Muscle Strength | 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. | 6 month post baseline |
| Lost to Follow-up |
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| NOT COMPLETED |
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| BG001 | 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. Control: monthly educational lectures on various topics |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | 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. Control: monthly educational lectures on various topics |
|
|
| Secondary | Change in Modified Physical Performance Test (PPT) | 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. | Posted | Mean | 95% Confidence Interval | Score on a scale | Baseline and 6 months |
|
|
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| Other Pre-specified | Effect of Exercise Intervention on Kyphosis | Investigators will measure change in Cobb angle on lateral spine radiograph. | Not Posted | 1 year post baseline | Participants |
| Other Pre-specified | Effect of Exercise Intervention on Secondary Measure of Physical Function | 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. | Not Posted | 1-year post baseline | Participants |
| Other Pre-specified | Effect of Exercise Intervention on Health Related Quality of Life (HRQOL) | Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires. | Not Posted | 6 month post baseline | Participants |
| Other Pre-specified | Effect of Exercise Intervention on Health Related Quality of Life (HRQOL) | Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires. | Not Posted | 1 year post baseline | Participants |
| Other Pre-specified | Effect of Exercise Intervention on Muscle Strength | 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. | Not Posted | 6 month post baseline | Participants |
| 0 |
| 51 |
| 0 |
| 51 |
| 37 |
| 51 |
| EG001 | 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. Control: monthly educational lectures on various topics | 0 | 48 | 0 | 48 | 17 | 48 |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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