Combining exercise coaching with insomnia treatment to reduce knee pain in older adults
Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis
This study tests if adding sleep treatment to exercise coaching can help older adults with knee pain feel better than just exercise coaching alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06580561 on ClinicalTrials.gov |
What this trial studies
This research compares the effectiveness of a personalized exercise coaching program combined with a cognitive behavioral therapy intervention for insomnia against exercise coaching alone in older adults suffering from knee osteoarthritis. The study aims to determine if the addition of insomnia treatment can lead to greater improvements in pain intensity, as measured by real-time data capture. Participants will receive remote coaching tailored to their needs, focusing on both physical activity and sleep improvement strategies.
Who should consider this trial
Good fit: Ideal candidates are older adults with a physician-diagnosed knee osteoarthritis and persistent insomnia symptoms.
Not a fit: Patients with systemic inflammatory musculoskeletal disorders or active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve quality of life for older adults with knee osteoarthritis.
How similar studies have performed: Other studies have shown promising results in combining exercise with behavioral interventions for pain management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Self-reported physician diagnosis of knee osteoarthritis * Persistent knee osteoarthritis-related pain of at least moderate intensity (as indicated in the protocol) * Indication of persistent symptoms of insomnia, determined by scoring on the Sleep Condition Indicator questionnaire (as indicated in the protocol) * If receiving medication for pain or sleep disturbances, having had no change in prescription in the previous three months and be willing to make no other changes to medications for pain or sleep during the active study period. * Adequate literacy level to ensure web-based surveys can be completed independently, as assessed using a brief 3-item literacy level screener Exclusion Criteria: * Concurrent diagnosis of a systemic, inflammatory musculoskeletal disorder (e.g., rheumatoid arthritis) * Active malignancy * Neurological conditions (e.g., movement disorders) * Any medical condition which would make graded increase of physical activity unsuitable (determined by a positive answer to the question: "Has a doctor or healthcare professional advised you to avoid physical activity for any reason?"). * Unable to understand English sufficiently to take part in the intervention. * Unable to provide electronic informed consent. * Evidence of significant cognitive impairment (i.e., ≥2 errors on a 6-item cognitive screener). * Presence of severe psychiatric disorder. * Currently participating in an interventional trial or a pain or sleep management program or having done so in the past six months. * Visual or hearing impairment that would prevent use of the intervention. * Serious physical health concerns necessitating surgery or with a prognosis \<6 months * Irregular sleep-wake schedule, e.g., shift work. * Self-report of diagnosis of a specific sleep disorder other than insomnia that is not currently adequately treated, e.g., sleep apnea or narcolepsy. * Currently meeting or exceeding physical activity guidance from the U.S. Department of Health and Human Services (noted in protocol)
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Whibley, PhD — University of Michigan
- Study coordinator: Jade Treder
- Email: trederj@med.umich.edu
- Phone: 734-936-2844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.