Combining exercise coaching with insomnia treatment to reduce knee pain in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.