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

Recruiting now · Not applicable

Conditions studied: Osteo Arthritis Knee and Hip, Low Back Pain, Insomnia

In brief

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.

Key facts

Study ID

NCT07532070

Run by

University of Sydney

People needed

384

Starts

2026-04-01

Expected to finish

2029-04-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Self-report engagement in >120 minute per week of at least moderate intensity physical activity within the past 6 months
• Current or previous engagement in CBT-I in the past 6 months
• Cognitive impairment (based on ≥7 on the Short Orientation Memory Concentration Test
• Received an injection of any substance into the study pain site in the previous 3 months
• Waiting or planning to receive an injection in the study pain site in the next 12 months
• Had within the past 12 months, or waiting or planning surgery in the next 12 months
• Neurological or systemic conditions that may affect physical function (e.g. Parkinson's, Active cancers, multiple sclerosis, rheumatoid arthritis, ankylosing spondylitis)
• Failing the American College of Sports Medicine pre-participation Health Screening Questionnaire without medical clearance to participate
• Unable to give informed consent and/or participate in the intervention and assessment procedures.
• Unable to speak or read English.

Where it is running

• Susan Wakil Health Building — Camperdown, New South Wales, Australia (enrolling)
• Madigan Army Medical Centre 9040A Jackson Ave Joint Base — San Antonio, Nevada, United States
• Brooke Army Medical Centre 3551 Roger Brooke Dr. Fort Sam Houston — San Antonio, Texas, United States
• The University of Queensland Therapies Building (84A) — Brisbane, Saint Lucia, Australia

Full record on ClinicalTrials.gov

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