COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL
Sponsor: University of Sydney
Trial Details
| Condition | Osteo Arthritis Knee and Hip, Low Back Pain, Insomnia |
| Intervention | Aerobic physical activity; CBT-I; Combined aerobic physical activity and CBT-I |
| Phase | NA |
| Status | Recruiting |
| Participants | 384 |
| Est. Completion | 1 Apr 2028 |
| Last Updated | 5 May 2026 |
Primary Outcome
Average Pain severity
Eligibility Criteria
Inclusion Criteria
INCLUSION CRITERIA Participants will be included if they have persistent LBP defined as i) age ≥18 years; ii) sought or seriously considered care from a primary care clinician or specialist for their LBP within the past 6 weeks; iii) have at least moderate LBP-related interference with normal work or daily activity (including both work outside the home and housework), as assessed by item 8 of the 36-item Short Form Health Survey OR hip or knee OA defined by the National Institute for Health and Care Excellence as: i) age ≥45 years; ii) activity-related hip or knee joint pain; and iii) no morning hip or knee stiffness, or morning stiffness ≤30 minutes) * An average pain of ≥4 on an 11-point numerical rating scale (NRS); 0 equals no pain, 10 equals worst pain possible over the last week * ≥11 on the Insomnia Severity Index * Access to a computer/laptop/tablet with internet availability for videoconferencing consultations * Willing and able to participate in video consultations * Verification that participants recruited in the US are beneficiaries of the Military Health System. EXCLUSION CRITERIA * 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.
Trial Sites
🇦🇺 Australian Sites (1)
Countries
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