Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis

Last updated: May 14, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Insomnia

Knee Injuries

Treatment

Personalized exercise coaching

Cognitive behavioral therapy for Insomnia

Clinical Study ID

NCT06580561
HUM00241352
1R01AG081299-01A1
  • Ages > 50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Self-reported physician diagnosis of knee osteoarthritis

  • Persistent knee osteoarthritis-related pain of at least moderate intensity (asindicated in the protocol)

  • Indication of persistent symptoms of insomnia, determined by scoring on the SleepCondition Indicator questionnaire (as indicated in the protocol)

  • If receiving medication for pain or sleep disturbances, having had no change inprescription in the previous three months and be willing to make no other changes tomedications 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

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 activityunsuitable (determined by a positive answer to the question: "Has a doctor orhealthcare 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 cognitivescreener).

  • Presence of severe psychiatric disorder.

  • Currently participating in an interventional trial or a pain or sleep managementprogram 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 isnot currently adequately treated, e.g., sleep apnea or narcolepsy.

  • Currently meeting or exceeding physical activity guidance from the U.S. Departmentof Health and Human Services (noted in protocol)

Study Design

Total Participants: 288
Treatment Group(s): 2
Primary Treatment: Personalized exercise coaching
Phase:
Study Start date:
November 04, 2024
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.