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

NCT07532070 | Not Yet Recruiting

• 2 other identifiers: 2024/HE001412HT9425-23-CPMRP-CORA
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic musculoskeletal pain; Low back pain; Hip osteoarthritis; Knee osteoarthritis; Poor sleep; Insomnia; Cognitive Behavioral Therapy for Insomnia (CBT-I); Exercise therapy; Lifestyle intervention; Non-pharmacological treatment; Randomized controlled trial; Sleep quality; Pain management; Physiotherapy; Wearable activity monitor; Sleep EEG

Outcome Measures

Primary Outcomes (1)

• Average Pain severity

  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.

  Baseline and 2, 6 (primary time-point) and 12 months

Secondary Outcomes (7)

• Worst pain severity

  Baseline and 2, 6 and 12 months

• Pain interference (PROMIS Short Form 8a)

  Baseline, 2 mths, 6 and 12 months.

• Health-related quality of life (EQ-5D-5L)

  Baseline, 2 mths, 6 and 12 months.

• Insomnia (Insomnia Severity Index)

  Baseline, 2 mths, 6 and 12 months.

• Sleep-related impairment (PROMIS-Sleep-related Impairment Short Form 8a)

  Baseline, 2 mths, 6 and 12 months.

Other Outcomes (7)

• Physical activity

  2-12 months

• Psychological (Orthopaedic Physical Therapy Investigators Network Yellow Flag (10-items)

  Baseline, 2 mths, 6 and 12 months.

• Physiological sleep

  0-12 months

Study Arms (3)

Aerobic physical activity

EXPERIMENTAL

Behavioral: Aerobic physical activity

CBT-I

EXPERIMENTAL

Cognitive behaviour therapy for insomnia

Behavioral: CBT-I

combined aerobic physical activity and CBT-I

EXPERIMENTAL

combined aerobic physical activity and cognitive behaviour therapy for insomnia

Behavioral: Combined aerobic physical activity and CBT-I

Interventions

Aerobic physical activity BEHAVIORAL

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.

Aerobic physical activity

CBT-I BEHAVIORAL

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.

CBT-I

Combined aerobic physical activity and CBT-I BEHAVIORAL

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.

combined aerobic physical activity and CBT-I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sydney: lead
• The University of Queensland: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Susan Wakil Health Building

Camperdown, New South Wales, 2200, Australia

Location

MeSH Terms

Conditions

Low Back Pain; Sleep Initiation and Maintenance Disorders; Osteoarthritis, Hip; Osteoarthritis, Knee; Agnosia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Alan A Nguyen, BSc/B.A

CONTACT

+610433014884; sleepfit.trial@sydney.edu.au

Michelle Hall, PhD, MSc, BSc (Hons)

CONTACT

+61 432128223; michelle.hall@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Biostatistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel-group randomized controlled trial comparing three lifestyle interventions for adults with chronic musculoskeletal pain and poor sleep. Participants will be randomly assigned to one of three groups: 1. Aerobic physical activity; 2. Cognitive Behavioral Therapy for Insomnia (CBT-I); 3. Combination of aerobic physical activity and CBT-I

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 1 year after publication of primary trial results with no end date.
• Access Criteria: De-identified individual participant data (IPD) underlying published results, along with the study protocol and data dictionary, may be shared with qualified researchers upon reasonable request. Requests must include a methodologically sound proposal outlining the research question, analysis plan, and statistical methods. Proposals will be reviewed by the trial steering committee to ensure scientific merit, appropriate use of the data, and compliance with ethical and governance requirements. Data will be shared only for analyses consistent with participant consent and the aims of the approved proposal. Approved applicants will be required to sign a data sharing agreement outlining conditions of use, including protection of participant confidentiality and prohibition of attempts to re-identify participants. Data will be provided via secure institutional transfer following approval of the request.

Locations

AU (1)