Clinical trial NCT06580561: Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis
Official title: Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Insomnia
Keywords: Exercise coaching
Cognitive behavioral therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-08-30
Enrollment: 288
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled participants will be randomized in blocks, stratified by biological sex, age, and baseline pain intensity (per protocol)
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in average pain intensity using a 0-10 numerical rating scale between baseline and the 8-week follow-up (post-intervention) period
timeFrame: Baseline, 8-week follow-up (post-intervention)
Secondary outcomes:
measure: Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a questionnaire between baseline and 8-week follow-up (post-intervention)
timeFrame: Baseline, 8-week (post-intervention)
measure: Change in the PROMIS Pain Interference 8a questionnaire between baseline and 8-week follow-up (post-intervention)
timeFrame: Baseline, 8-week (post-intervention)
measure: Change in the PROMIS Physical Function questionnaire between baseline and 8-week follow-up (post-intervention)
timeFrame: Baseline, 8-week (post-intervention)
measure: Change in the Quality of Life subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) between baseline and 8-week follow-up (post-intervention)
timeFrame: Baseline, 8-week (post-intervention)
measure: Patient Global Impression of Change at 8-week follow-up (post-intervention)
timeFrame: 8-week (post-intervention)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Daniel Whibley, PhD
role: PRINCIPAL_INVESTIGATOR
References: