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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 50 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06580561
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Michigan
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Daniel Whibley, PhD
Principal Investigator Affiliation University of Michigan
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis, Insomnia
Arms & Interventions

Arms

Experimental: Move and Snooze program

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

Experimental: Personalized exercise program

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Jade Treder

[email protected]

734-936-2844