No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
288 (estimated)
Sponsor
University of Michigan · Other
Who this trial is looking for
This trial is looking for older adults with knee osteoarthritis who also have trouble sleeping. Participants will receive personalized exercise coaching along with support to improve their sleep.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with knee osteoarthritis.
I have moderate or worse knee pain.
I have trouble sleeping.
I can follow instructions in English.
I can complete surveys online.
I have not changed my pain or sleep medication in the last three months.
You may not be able to join if
I have a systemic inflammatory condition like rheumatoid arthritis.
I have active cancer.
I have a serious neurological condition.
A doctor has told me to avoid physical activity.
I have significant cognitive impairment.
I have a severe psychiatric disorder.
I currently participate in another treatment program for pain or sleep.
I have a serious health issue that may need surgery soon.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This research will compare the effectiveness of a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention to remotely delivered personalized exercise coaching alone for knee osteoarthritis pain.
The study team hypothesize that the combined intervention will result in greater improvements in patient-reported pain intensity, recorded with real-time da…
This research will compare the effectiveness of a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention to remotely delivered personalized exercise coaching alone for knee osteoarthritis pain.
The study team hypothesize that the combined intervention will result in greater improvements in patient-reported pain intensity, recorded with real-time data capture, than remotely delivered exercise coaching alone.
Trial Locations
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Status
Eligibility 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 question…
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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