COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL

This study aims to find out which lifestyle approach works best for people with chronic musculoskeletal pain (such as low back pain or hip/knee osteoarthritis) who also have poor sleep. Participants will be randomly assigned to one of three 12-month home-based programs: exercise, cognitive behavioral therapy for insomnia (CBT-I), or a combination of both. Each program includes up to 10 online sessions with a physiotherapist and guidance on managing pain, sleep, and physical activity. We will measure changes in pain, sleep quality, and overall health using questionnaires, wearable devices, sensory tests, and blood samples. The goal is to improve understanding of non-medication treatments for pain and sleep problems.

NCT Number	NCT07532070
Lead Sponsor	University of Sydney Collaborators: The University of Queensland, Uniformed Services University of the Health Sciences
Conditions	Osteo Arthritis Knee and Hip, Low Back Pain, Insomnia
Enrollment	384 participants
Start Date	2026-04
Primary Completion	2028-04 (estimated)
Study Completion	2029-04 (estimated)
Updated on ClinicalTrials.gov	2026-05-05