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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• The University of Queensland

  collaborator OTHER

• Uniformed Services University of the Health Sciences

  collaborator FED

• University of Sydney

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2028-04-30

Completion

2029-04-30

Countries

• United States
• Australia

Study Locations