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

NCT ID: NCT06580561

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2028-08-31

Brief 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.

Conditions

Knee Osteoarthritis; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Move and Snooze program

This includes the personalized exercise program plus Cognitive Behavioral Therapy for Insomnia (CBT-I).

Group Type: EXPERIMENTAL

Personalized exercise coaching

Intervention Type: BEHAVIORAL

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).

Cognitive behavioral therapy for Insomnia

Intervention Type: BEHAVIORAL

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.

Personalized exercise program

Group Type: EXPERIMENTAL

Personalized exercise coaching

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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 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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Daniel Whibley

Assistant Professor of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Whibley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jade Treder

Role: CONTACT

trederj@med.umich.edu

734-936-2844

Kristin Pickup

Role: CONTACT

knpicku@med.umich.edu

734-764-4072

Facility Contacts

Jade Treder

Role: primary

trederj@med.umich.edu

734-936-2844

Other Identifiers

1R01AG081299-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00241352

Identifier Type: -

Identifier Source: org_study_id