N/A
N=99
Study of Hyperkyphosis, Exercise and Function-SHEAF
Kyphosis
Bottom Line
View on ClinicalTrials.gov: NCT01751685 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Change in Cobb Angle of Kyphosis — -3.3; -0.3 Degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Kyphosis-specific spinal strengthening exercises (Behavioral); Control (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cobb Angle of Kyphosis |
-3.3; -0.3 | — |
| SECONDARY Change in Modified Physical Performance Test (PPT) |
0.3; 0.8 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01751685). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.