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

Overview

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.

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.

Interventions

• 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.
• 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.
• 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 w

Primary outcome measures

• Average Pain severity [Time frame: Baseline and 2, 6 (primary time-point) and 12 months]

Secondary outcome measures (7)

• Worst pain severity [Time frame: Baseline and 2, 6 and 12 months]
• Pain interference (PROMIS Short Form 8a) [Time frame: Baseline, 2 mths, 6 and 12 months.]
• Health-related quality of life (EQ-5D-5L) [Time frame: Baseline, 2 mths, 6 and 12 months.]
• Insomnia (Insomnia Severity Index) [Time frame: 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.]
• Physical Function (PROMIS-Physical Function Short Form 8c v2.0) [Time frame: Baseline, 2 mths, 6 and 12 months.]
• Satisfaction with the intervention [Time frame: 2 mths, 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• Madigan Army Medical Centre 9040A Jackson Ave Joint Base — San Antonio
• Brooke Army Medical Centre 3551 Roger Brooke Dr. Fort Sam Houston — San Antonio

Australia · 2 centers

• Susan Wakil Health Building — Camperdown
• The University of Queensland Therapies Building (84A) — Brisbane

Identifiers

NCT: NCT07532070 · 2024/HE001412 · HT9425-23-CPMRP-CORA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗