Study of Hyperkyphosis, Exercise and Function (SHEAF)
Specific spinal strengthening exercises
Purpose and Objective
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.
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.
Treatment: Kyphosis-specific spinal strengthening exercises
Clinical Trial Sponsor
This clinical trial is sponsored by University of California, San Francisco (UCSF).
Recruiting Location (United States)
San Francisco, California, United States, 94143
Contact: Wendy Katzman, PT DPTSc OCS 415-514-6776
Principal Investigator: Wendy Katzman, PT, DPTSc, OCS
Eligibility, Inclusion and Exclusion 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
- 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
* Additional inclusion/exclusion criteria apply. Please consult with your physician to review the complete eligibility criteria.