NCT06580561 · University of Michigan
Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Personalized exercise coaching
This is a 6-session personalized exercise coaching program (delivered over 8 weeks). All participants will complete six 30-minute scheduled online or phone sessions with a health coach as part of a manualized personalized exercise program (once per week for the first four sessions and then once every two weeks for the remaining two sessions).
BEHAVIORAL
Cognitive behavioral therapy for Insomnia
This is a 6-week course of automated, digitally delivered cognitive behavioral therapy for insomnia delivered by the online program Sleepio. The weekly sessions will last approximately 15-20 minutes. Session content comprises evidence-based cognitive and behavioral techniques including Stimulus Control Therapy and Sleep Restriction Therapy, sleep hygiene education, and relaxation exercises.
Primary outcome measures
Change in average pain intensity using a 0-10 numerical rating scale between baseline and the 8-week follow-up (post-intervention) period
Time frame: Baseline, 8-week follow-up (post-intervention)
This is a one question numerical rating scale in which participants select from 0 (no pain) -10 (worst pain imaginable) numerical rating scale 4 times a day over 7 days during each assessment period (baseline and 8-week follow-up). These four within-day ratings collected over seven days will be averaged for each participant to provide a single pain intensity rating for each assessment period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Ann Arbor, Michigan
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations