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Exercise, sleep therapy, or both for long-term musculoskeletal pain with poor sleep

Compares exercise, insomnia therapy and both in adults with chronic joint or back pain.

Key facts

Who runs it
University of Sydney
Where
San Antonio, United StatesSee the 2 sitesAlso in 1 other country, 2 sites
Trial code
Registry title
COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL
Status
Recruiting
People taking part
384 people, planned
Started
Apr 2026
Expected to end
Apr 2029
Type of study
Interventional, 3 groups
Treatments tested
  • Aerobic physical activity
  • CBT-I
  • Combined aerobic physical activity and CBT-I
Record updated
5 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-lasting low back pain or hip or knee osteoarthritis who also sleep poorly. They will follow a home program of exercise, sleep therapy (CBT-I), or both.

Age
18 years or older for low back pain; 45 years or older for hip or knee osteoarthritis.
Sex
All sexes can join.
Disease stage
Persistent low back pain that has led you to seek or seriously consider care in the past 6 weeks, with at least moderate impact on work or daily activity. Or hip or knee osteoarthritis: joint pain with activity, and no morning stiffness or stiffness of 30 minutes or less. Average pain of 4 or more on a 0 to 10 scale over the last week. A score of 11 or more on the Insomnia Severity Index.
Earlier treatment
No CBT-I in the past 6 months. No injection into the painful area in the past 3 months. No surgery in the past 12 months.

Main reasons for not taking part

  • More than 120 minutes per week of at least moderate physical activity in the past 6 months.
  • Injection or surgery planned or awaited in the next 12 months.
  • Memory or thinking problems (score of 7 or more on a short memory test).
  • Nerve or whole-body conditions that affect movement, such as Parkinson's, active cancer, multiple sclerosis, rheumatoid arthritis or ankylosing spondylitis.
  • Cannot speak or read English, or no computer or tablet with internet for video calls. People in the US must be covered by the Military Health System.

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Current or previous engagement in CBT-I in the past 6 months
  • Received an injection of any substance into the study pain site in the previous 3 months
  • Had within the past 12 months, or waiting or planning surgery in the next 12 months
  • Cognitive impairment (based on ≥7 on the Short Orientation Memory Concentration Test
  • 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
  • Self-report engagement in >120 minute per week of at least moderate intensity physical activity within the past 6 months
  • Waiting or planning to receive an injection in the study pain site in the next 12 months
  • Unable to give informed consent and/or participate in the intervention and assessment procedures
  • Unable to speak or read English

Where in United States

Also in 1 other country, 2 sites

  • Brooke Army Medical Centre 3551 Roger Brooke Dr. Fort Sam HoustonSan Antonio, United StatesContact: Daniel RhonNot yet recruiting
  • Madigan Army Medical Centre 9040A Jackson Ave Joint BaseSan Antonio, United StatesContact: Daniel RhonNot yet recruiting

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Aerobic physical activityTreatment being tested
  • CBT-ITreatment being tested

    Cognitive behaviour therapy for insomnia

  • combined aerobic physical activity and CBT-ITreatment being tested

    combined aerobic physical activity and cognitive behaviour therapy for insomnia

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL
Plain-language title
Exercise, sleep therapy, or both for long-term musculoskeletal pain with poor sleepGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
5 May 2026