Kyphosis
Conditions
Keywords
kyphosis
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALKyphosis-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.
OTHERControl
monthly educational lectures on various topics
Sponsors
National Institute on Aging (NIA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cobb Angle of Kyphosis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Physical Performance Test (PPT) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of Exercise Intervention on Kyphosis | 1 year post baseline | Investigators will measure change in Cobb angle on lateral spine radiograph. |
| Effect of Exercise Intervention on Secondary Measure of Physical Function | 1-year post baseline | 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. |
| Effect of Exercise Intervention on Health Related Quality of Life (HRQOL) | 6 month post baseline | Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires. |
| Effect of Exercise Intervention on Muscle Strength | 6 month post baseline | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| 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 | 48 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-mo Followup | Lost to Follow-up | 5 | 0 |
| 6-mo Followup | Lost to Follow-up | 0 | 1 |
| 6-mo Followup | Missed study visit | 1 | 0 |
| 6-mo Followup | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Control | Total | Kyphosis-specific Spinal Exercises |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 48 Participants | 99 Participants | 51 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 70.2 years | 70.6 years | 71.0 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 48 participants | 99 participants | 51 participants |
| Sex: Female, Male Female | 36 Participants | 71 Participants | 35 Participants |
| Sex: Female, Male Male | 12 Participants | 28 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 48 |
| other Total, other adverse events | 37 / 51 | 17 / 48 |
| serious Total, serious adverse events | 0 / 51 | 0 / 48 |
Outcome results
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Kyphosis-specific Spinal Exercises | Change in Cobb Angle of Kyphosis | -3.3 Degrees |
| Control | Change in Cobb Angle of Kyphosis | -0.3 Degrees |
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Kyphosis-specific Spinal Exercises | Change in Modified Physical Performance Test (PPT) | 0.3 Score on a scale |
| Control | Change in Modified Physical Performance Test (PPT) | 0.8 Score on a scale |
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.
Time frame: 6 month post baseline
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.
Time frame: 1 year post baseline
Other Pre-specified
Effect of Exercise Intervention on Kyphosis
Investigators will measure change in Cobb angle on lateral spine radiograph.
Time frame: 1 year post baseline
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.
Time frame: 6 month post baseline
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.
Time frame: 1-year post baseline