Move and snooze: new study tests sleep therapy to boost exercise benefits for knee pain
NCT ID NCT06580561
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two approaches for older adults with knee osteoarthritis and insomnia: personalized exercise coaching alone versus exercise plus a digital insomnia treatment. Researchers want to see if adding sleep therapy leads to greater pain relief. The trial involves 288 participants and is delivered remotely via phone or online sessions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- personalized exercise coaching and cognitive behavioral therapy for insomnia
- What this could lead to
- If successful, this could point toward a combined non-drug approach to better manage knee osteoarthritis pain and sleep problems in older adults.
- What could go wrong
- This is a relatively small, early-stage behavioral study. The added insomnia treatment may not significantly improve pain beyond exercise alone, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 288 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Custom knee guides put to the test in obese patients
- Can a shot of your own blood ease arthritic knees?
- Can magnetic brain zaps ease the pain of a sleepless body?
- Can poor sleep make you hurt more? study probes Insomnia's link to pain
- 5,000 knee arthritis patients tracked to crack the treatment code
- Does soreness after exercise disrupt sleep more for people with insomnia?