N/A
Completed N=99
Study of Hyperkyphosis, Exercise and Function-SHEAF
Kyphosis
Source: ClinicalTrials.gov NCT01751685 ↗
Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Change in Cobb Angle of Kyphosis — -3.3; -0.3 Degrees
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.
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 | — |
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. Informational only — not medical advice.