Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults with Knee Osteoarthritis
NCT Number: NCT06580561
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Osteoarthritis|Insomnia
Sponsor: University of Michigan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 288
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-02

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.

Primary Outcome Measures: Change in average pain intensity using a 0-10 numerical rating scale between baseline and the 8-week follow-up (post-intervention) period, This is a one question numerical rating scale in which participants select from 0 (no pain) -10 (worst pain imaginable) numerical rating scale 4 times a day over 7 days during each assessment period (baseline and 8-week follow-up). These four within-day ratings collected over seven days will be averaged for each participant to provide a single pain intensity rating for each assessment period., Baseline, 8-week follow-up (post-intervention)
Secondary Outcome Measures: Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a questionnaire between baseline and 8-week follow-up (post-intervention), There are 3 questions that participants answer and from no pain (1) - very severe (5). There is a total score of 15 with a higher score indicating higher pain intensity., Baseline, 8-week (post-intervention)|Change in the PROMIS Pain Interference 8a questionnaire between baseline and 8-week follow-up (post-intervention), There are 8 questions regarding the extent to which pain has interfered with activities over the past 7 days, ranging from not at all (1) - Very much (5). Total scores range from 8 to 40, with a higher score representing higher interference due to pain., Baseline, 8-week (post-intervention)|Change in the PROMIS Physical Function questionnaire between baseline and 8-week follow-up (post-intervention), There are 4 questions regarding function that participants answer and from without any difficulty (5) - unable to do (1). And 4 questions for that participants select from not at all (5) to cannot do (1). There is a total score of 40 with a higher score indicating greater physical function., Baseline, 8-week (post-intervention)|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), The KOOS quality of life subscale includes 4 questions. The Score subscale is scored using a Likert scale with five possible answers, ranging from 0 (no problems) to 4 (extreme problems). The quality of life subscale score is then normalized to a 0-100 scale, with higher scores equaling better status. 0 represents extreme knee problems and 100 represents no knee problems., Baseline, 8-week (post-intervention)|Patient Global Impression of Change at 8-week follow-up (post-intervention), This is a one question survey that participants will select from very much improved (1) -very much worse (7) since the start of the study and overall status. A lower number indicates better outcome., 8-week (post-intervention)