An interventional study of Kyphosis-specific spinal strengthening exercises and Control in Kyphosis, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-07.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
135 studies on the registry are indexed under Kyphosis; 26 are open to participants now.
This study's enrollment of 99 is above the median of 44 across 78 interventional studies indexed under Kyphosis.
Browse Kyphosis studies →University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Kyphosis-specific spinal strengthening exercises
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.
Other: Control
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.
monthly educational lectures on various topics
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.
Time frame: Baseline and 6 months
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.
Time frame: Baseline and 6 months
Effect of Exercise Intervention on Kyphosis
Investigators will measure change in Cobb angle on lateral spine radiograph.
Time frame: 1 year post baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 month post baseline
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
| Milestone | Kyphosis-specific Spinal Exercises | Control |
|---|---|---|
| Started | 51 | 48 |
| Completed | 48 | 45 |
| Not completed | 3 | 3 |
| Withdrew: Missed study visit | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Milestone | Kyphosis-specific Spinal Exercises | Control |
|---|---|---|
| Started | 48 | 45 |
| Completed | 43 | 45 |
| Not completed | 5 | 0 |
| Withdrew: Lost to follow-up | 5 | 0 |
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.
| Degrees | Kyphosis-specific Spinal Exercises | Control |
|---|---|---|
| Change in Cobb Angle of Kyphosis | -3.3 (-4.9 to -1.7) | -0.3 (-1.9 to 1.2) |
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.
| Score on a scale | Kyphosis-specific Spinal Exercises | Control |
|---|---|---|
| Change in Modified Physical Performance Test (PPT) | 0.3 (-0.2 to 0.8) | 0.8 (0.3 to 1.3) |
Investigators will measure change in Cobb angle on lateral spine radiograph.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires.
Results for this outcome have not been posted.
Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kyphosis-specific Spinal Exercises | 0/51 (0%) | 0/51 (0%) | 37/51 (72.5%) |
| Control | 0/48 (0%) | 0/48 (0%) | 17/48 (35.4%) |
| Event | Kyphosis-specific Spinal Exercises | Control |
|---|---|---|
| Musculoskeletal PainMusculoskeletal and connective tissue disorders | 30/51 | 12/48 |
| FallsMusculoskeletal and connective tissue disorders | 13/51 | 8/48 |
| Age, Categorical(Participants) | Kyphosis-specific Spinal Exercises | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 51 | 48 | 99 |
| Age, Continuous(years) | Kyphosis-specific Spinal Exercises | Control | Total |
|---|---|---|---|
| Mean | 71.0 (64.5 to 77.5) | 70.2 (64.5 to 75.9) | 70.6 (64.5 to 75.9) |
| Sex: Female, Male(Participants) | Kyphosis-specific Spinal Exercises | Control | Total |
|---|---|---|---|
| Female | 35 | 36 | 71 |
| Male | 16 | 12 | 28 |
| Race and Ethnicity Not Collected(Participants) | Kyphosis-specific Spinal Exercises | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Kyphosis-specific Spinal Exercises | Control | Total |
|---|---|---|---|
| United States | 51 | 48 | 99 |
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