NCT07532070

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Chronic musculoskeletal pain, such as low back pain and osteoarthritis of the hip or knee, is common and often associated with poor sleep, reduced function, and lower quality of life. Lifestyle factors like exercise and sleep management can influence pain and well-being, but it is unclear which approach works best for people with both chronic pain and sleep problems. This randomized controlled trial will compare the effectiveness of three 12-month home-based lifestyle interventions: Exercise program Cognitive Behavioral Therapy for Insomnia (CBT-I) Combination of exercise and CBT-I Participants will be adults with chronic low back pain and/or hip or knee osteoarthritis lasting at least 6 months, who also report poor sleep. Eligible participants will be randomly assigned to one of the three groups. All groups will receive up to 10 online consultations with a physiotherapist over 9 months, plus tailored guidance on pain, sleep, and physical activity. Assessments will occur at baseline, 2 months, 6 months, and 12 months, and will include: Online questionnaires on pain, sleep, and quality of life Wearable activity and sleep monitoring Sensory testing Blood samples to explore biological markers related to pain and sleep Sleep EEG recordings at baseline and 6 months The primary aim is to determine which lifestyle intervention provides the greatest improvement in pain and sleep outcomes. Secondary aims include understanding changes in physical function, mood, and biological markers. Findings will help guide future non-medication treatments for people with chronic pain and sleep difficulties.

Conditions

• Osteo Arthritis Knee and Hip
• Low Back Pain
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Aerobic physical activity	This intervention consists of a structured, individualised aerobic physical activity program delivered via videoconferencing by a physiotherapist. The program focuses exclusively on aerobic-based activities and does not include any sleep-specific or cognitive behavioural components. Exercise prescription will be tailored and progressively adjusted based on participant tolerance, goals, and clinical guidelines.
BEHAVIORAL	CBT-I	This intervention consists of cognitive behavioural therapy for insomnia (CBT-I) delivered via videoconferencing by a physiotherapist trained in CBT-I principles. The program targets sleep-related behaviours and cognitions using evidence-based CBT-I strategies, including sleep restriction, stimulus control, cognitive restructuring, and sleep hygiene education. No structured physical activity or exercise prescription is included.
BEHAVIORAL	Combined aerobic physical activity and CBT-I	This intervention integrates both a structured aerobic physical activity program and cognitive behavioural therapy for insomnia (CBT-I) within the same physiotherapist-delivered videoconferencing consultations. Participants receive both aerobic physical activity alongside CBT-I strategies targeting sleep behaviours and cognitions. The combined intervention delivers both components concurrently and differs from the single-component interventions by addressing physical aerobic activity and sleep within an integrated treatment framework.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2029-04-01
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: Australia