RECRUITING

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

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Conditions

Knee OsteoarthritisInsomniaExercise coachingCognitive behavioral therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-04
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06580561

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-reported physician diagnosis of knee osteoarthritis
  2. * Persistent knee osteoarthritis-related pain of at least moderate intensity (as indicated in the protocol)
  3. * Indication of persistent symptoms of insomnia, determined by scoring on the Sleep Condition Indicator questionnaire (as indicated in the protocol)
  4. * 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.
  5. * Adequate literacy level to ensure web-based surveys can be completed independently, as assessed using a brief 3-item literacy level screener
  1. * Concurrent diagnosis of a systemic, inflammatory musculoskeletal disorder (e.g., rheumatoid arthritis)
  2. * Active malignancy
  3. * Neurological conditions (e.g., movement disorders)
  4. * 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?").
  5. * Unable to understand English sufficiently to take part in the intervention.
  6. * Unable to provide electronic informed consent.
  7. * Evidence of significant cognitive impairment (i.e., ≥2 errors on a 6-item cognitive screener).
  8. * Presence of severe psychiatric disorder.
  9. * Currently participating in an interventional trial or a pain or sleep management program or having done so in the past six months.
  10. * Visual or hearing impairment that would prevent use of the intervention.
  11. * Serious physical health concerns necessitating surgery or with a prognosis \<6 months
  12. * Irregular sleep-wake schedule, e.g., shift work.
  13. * Self-report of diagnosis of a specific sleep disorder other than insomnia that is not currently adequately treated, e.g., sleep apnea or narcolepsy.
  14. * Currently meeting or exceeding physical activity guidance from the U.S. Department of Health and Human Services (noted in protocol)

Contacts and Locations

Study Contact

Jade Treder
CONTACT
734-936-2844
trederj@med.umich.edu
Kristin Pickup
CONTACT
734-764-4072
knpicku@med.umich.edu

Principal Investigator

Daniel Whibley, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Daniel Whibley, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-04
Study Completion Date2027-02

Study Record Updates

Study Start Date2024-11-04
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • Exercise coaching
  • Cognitive behavioral therapy

Additional Relevant MeSH Terms

  • Knee Osteoarthritis
  • Insomnia