COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL
Aerobic physical activityCBT-ICombined aerobic physical activity and CBT-I
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.
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.
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Average Pain severity — Baseline and 2, 6 (primary time-point) and 12 months Average pain severity at the designated study site will be measured using a 0-10 Numerical Rating Scale, with higher scores indicating greater pain. Assessments will be conducted at baseline and at 2, 6, and 12 months. Primary intervention efficacy will be evaluated by between-group differences in change in average NRS pain from baseline to 6 months.
Trial sites (4)
Facility
City
Region
Status
Madigan Army Medical Centre 9040A Jackson Ave Joint Base
San Antonio
Nevada
Not Yet Recruiting
Brooke Army Medical Centre 3551 Roger Brooke Dr. Fort Sam Houston
San Antonio
Texas
Not Yet Recruiting
Susan Wakil Health Building
Camperdown
New South Wales
Recruiting
The University of Queensland Therapies Building (84A)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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