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

May 4, 2026 updated by: University of Sydney
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic musculoskeletal pain, such as low back pain and osteoarthritis of the hip or knee, is common and often associated with poor sleep, reduced function, and lower quality of life. Lifestyle factors like exercise and sleep management can influence pain and well-being, but it is unclear which approach works best for people with both chronic pain and sleep problems.

This randomized controlled trial will compare the effectiveness of three 12-month home-based lifestyle interventions:

Exercise program Cognitive Behavioral Therapy for Insomnia (CBT-I) Combination of exercise and CBT-I

Participants will be adults with chronic low back pain and/or hip or knee osteoarthritis lasting at least 6 months, who also report poor sleep. Eligible participants will be randomly assigned to one of the three groups. All groups will receive up to 10 online consultations with a physiotherapist over 9 months, plus tailored guidance on pain, sleep, and physical activity.

Assessments will occur at baseline, 2 months, 6 months, and 12 months, and will include:

Online questionnaires on pain, sleep, and quality of life Wearable activity and sleep monitoring Sensory testing Blood samples to explore biological markers related to pain and sleep Sleep EEG recordings at baseline and 6 months

The primary aim is to determine which lifestyle intervention provides the greatest improvement in pain and sleep outcomes. Secondary aims include understanding changes in physical function, mood, and biological markers. Findings will help guide future non-medication treatments for people with chronic pain and sleep difficulties.

Study Type

Interventional

Enrollment (Estimated)

384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2200
        • Recruiting
        • Susan Wakil Health Building
        • Principal Investigator:
          • Michelle Hall, PhD, MSc, BSc (Hons)
    • Saint Lucia
      • Brisbane, Saint Lucia, Australia, 4072
        • Not yet recruiting
        • The University of Queensland Therapies Building (84A)
        • Contact:
          • David Klyne
        • Contact:
        • Principal Investigator:
          • David Klyne
  • United States
    • Nevada
      • San Antonio, Nevada, United States, 78234
    • Texas
      • San Antonio, Texas, United States, 78234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic physical activity
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.
Experimental: CBT-I
Cognitive behaviour therapy for insomnia
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.
Experimental: combined aerobic physical activity and CBT-I
combined aerobic physical activity and cognitive behaviour therapy for insomnia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Pain severity
Time Frame: 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.
Baseline and 2, 6 (primary time-point) and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Worst pain severity
Time Frame: Baseline and 2, 6 and 12 months
Worst pain severity at the designated study site over the past week will be assessed using the numeric rating scale, ranging from 0 ("no pain") to 10 ("worst pain possible").
Baseline and 2, 6 and 12 months
Pain interference (PROMIS Short Form 8a)
Time Frame: Baseline, 2 mths, 6 and 12 months.
Scored using 8 questions (5-point Likert Scale) related to the consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities in the past 7 days. 5-point Likert scale. Ranges from 0-10; where 0 = 'no pain' and 10 = 'worst pain possible'
Baseline, 2 mths, 6 and 12 months.
Health-related quality of life (EQ-5D-5L)
Time Frame: Baseline, 2 mths, 6 and 12 months.
Scored using 5 items (5-point Likert Scale) about mobility, self-care, pain, usual activities, and psychological status over the past week, with a Likert scale ranging from no problem to extreme pain or discomfort.Score ranges from 0 to 100. Higher scores indicate a better quality of life.
Baseline, 2 mths, 6 and 12 months.
Insomnia (Insomnia Severity Index)
Time Frame: Baseline, 2 mths, 6 and 12 months.
Scored using a 7-items (5-point Likert scale) that captures disturbances in sleep consistent with insomnia. Score ranges 0 to 28. Higher scores indicating greater insomnia severity.
Baseline, 2 mths, 6 and 12 months.
Sleep-related impairment (PROMIS-Sleep-related Impairment Short Form 8a)
Time Frame: Baseline, 2 mths, 6 and 12 months.
Scored using 8 items (5-point Likert scale) on perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep or impaired alertness. Ranging from "very poor/not at all" to "very good/very much". Score ranges from 8 to 40. Higher scores indicate greater sleep-related impairments.
Baseline, 2 mths, 6 and 12 months.
Physical Function (PROMIS-Physical Function Short Form 8c v2.0)
Time Frame: Baseline, 2 mths, 6 and 12 months.
Scored using 8 items on 5 point Likert scales, capturing capacity to perform activities such as household chores, walking, climbing stairs, and lifting, as well as whether health limits these activities Ranging from "without any difficulty/not at all" to "unable to do/cannot do". Score ranges from 8 to 40. Higher scores indicate less physical dysfunction.
Baseline, 2 mths, 6 and 12 months.
Satisfaction with the intervention
Time Frame: 2 mths, 12 months
Self-reported. Evaluation as perceived satisfaction. Ranging from "strongly agree" to "strongly disagree". Score range from 0 to 44 with higher score indicating less satisfaction.
2 mths, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 2-12 months
Time spent in at least moderate intensity activity per week using a wrist-worn wearable. Time (minutes)
2-12 months
Psychological (Orthopaedic Physical Therapy Investigators Network Yellow Flag (10-items)
Time Frame: Baseline, 2 mths, 6 and 12 months.
Scored using 10-item (various point Likert scales) about psychological distress (e.g. negative mood, fear-avoidance and positive coping). Ranging from 0 to 11 "yellow flags". Higher number indicates more yellow flags.
Baseline, 2 mths, 6 and 12 months.
Physiological sleep
Time Frame: 0-12 months

Sleep efficiency (wearable).

Time asleep relative to time in bed
0-12 months
Medication use
Time Frame: Baseline, 2 mths, 6 and 12 months.
Self-reported using customised survey. Will report the number or percentage of participants for each type of medication.
Baseline, 2 mths, 6 and 12 months.
Co-interventions
Time Frame: Baseline, 2 mths, 6 and 12 months.
Self-reported using customised survey. Will report the number or percentage of participants for each type of co-intervention.
Baseline, 2 mths, 6 and 12 months.
Adverse events
Time Frame: Throughout 0-2 months, 6 and 12 months
Physio treatment notes on REDCap (0-2 months) and self reported by participant at 6 months and 12 months also on REDcap. The number and type of events, related to this study.
Throughout 0-2 months, 6 and 12 months
Sleep disturbance (PROMIS-Sleep Disturbance Short Form v1.0 8a)
Time Frame: Baseline, 2 mths, 6 and 12 months.
Scored using 8 items (5-point Likert scale) on perceptions of sleep quality, depth, difficulties falling asleep and staying asleep, as well as sleep satisfaction over the past 2 weeks. Ranging from "very poor/not at all" to "very good/very severe". Score ranges from 8 to 40. Higher scores indicate greater sleep disturbances.
Baseline, 2 mths, 6 and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sydney

Collaborators

Uniformed Services University of the Health Sciences
The University of Queensland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/HE001412
  • HT9425-23-CPMRP-CORA (Other Grant/Funding Number: US Department of Defence (DoD) Chronic Pain Medical Research Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data will be made available upon reasonable request following publication of the primary outcomes. Requests will be reviewed by the study investigators and require a data sharing agreement. Data will be shared for research purposes consistent with participant consent and ethical approvals.

IPD Sharing Time Frame

Beginning 1 year after publication of primary trial results with no end date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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