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SLEEPFIT Trial: Exercise and CBT-I for Chronic Pain and Poor Sleep

This study, called SLEEPFIT, is looking for adults aged 18 and older with chronic musculoskeletal pain (like low back pain or hip/knee osteoarthritis) who also have trouble sleeping. It aims to find out if exercise, cognitive behavioral therapy for insomnia (CBT-I), or a combination of both, works best to improve pain and sleep. You would be randomly assigned to one of three home-based programs, each including up to 10 online sessions with a physiotherapist over 12 months. The study will measure your pain severity, sleep quality, and overall health using questionnaires, wearable devices, and other tests. The goal is to better understand non-medication treatments for these common problems. The current recruitment status is unclear.

Study design
This is an interventional study with an unclear status, planning to enroll 384 participants. Participants will be randomly assigned to one of three groups: aerobic physical activity, CBT-I, or a combination of both.
What's involved
You would participate in up to 10 online sessions with a physiotherapist over 9 months. Assessments will occur at baseline, 2 months, 6 months, and 12 months, including questionnaires, wearable monitoring, sensory testing, and blood samples.
Compensation
Not stated in the trial record.
Follow-up
Your average pain severity will be measured at 2, 6 (primary time-point), and 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07532070

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

Recruiting
NAAges 18+InterventionalTreatment
University of Sydney
~384 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Aerobic physical activityCBT-ICombined aerobic physical activity and CBT-I

At a glance

Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average Pain severity
Measured over Baseline and 2, 6 (primary time-point) and 12 months

Conditions

Osteo Arthritis Knee and Hip
Low Back Pain
Insomnia

Explore related trials

Hip OsteoarthritisInsomniaLower Back PainOsteoarthritis of knee

Where it's being run

4 sites across 4 states
Nevada1
Texas1
New South Wales1
Saint Lucia1

Who to contact

Alan A Nguyen, BSc/B.A
[email protected]
+610433014884
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Average Pain severityBaseline 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.