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

Purpose

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.

Conditions

Knee Osteoarthritis
Insomnia

Eligibility

Eligible Ages: Over 50 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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)

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Enrolled participants will be randomized in blocks, stratified by biological sex, age, and baseline pain intensity (per protocol)
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Move and Snooze program	This includes the personalized exercise program plus Cognitive Behavioral Therapy for Insomnia (CBT-I).	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.
Experimental Personalized exercise program		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).

Recruiting Locations

University of Michigan
Ann Arbor, Michigan 48109

Contact:
Jade Treder
734-936-2844
trederj@med.umich.edu

More Details

NCT ID: NCT06580561
Status: Recruiting
Sponsor: University of Michigan

Study Contact

Jade Treder
734-936-2844
trederj@med.umich.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.