Osteo Arthritis Knee and HipSLEEPFITNCT07532070
COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL
A study testing Aerobic physical activity, CBT-I and Combined aerobic physical activity and CBT-I in people with Osteo Arthritis Knee and Hip and Low Back Pain, run by University of Sydney at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee and Hip, Low Back Pain, Insomnia
- What is being tested?
- Aerobic physical activity, CBT-I and Combined aerobic physical activity and CBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States2 sites, 2 recruiting
- Not yet recruiting
Madigan Army Medical Centre 9040A Jackson Ave Joint Base
San Antonio, Nevada, 78234
Daniel Rhon, daniel.rhon@usuhs.edu
Rachel Mayhew, rachel.j.mayhew.ctr@health.mil
- Not yet recruiting
Brooke Army Medical Centre 3551 Roger Brooke Dr. Fort Sam Houston
San Antonio, Texas, 78234
Daniel Rhon, daniel.rhon@usuhs.edu
Rachel Mayhew, rachel.j.mayhew.ctr@health.mil
Australia2 sites, 2 recruiting
- Not yet recruiting
The University of Queensland Therapies Building (84A)
Brisbane, Saint Lucia, 4072
David Klyne
Camille Thomas, camillemaeva.thomas@uq.edu.au
- Recruiting
Susan Wakil Health Building
Camperdown, New South Wales, 2200
Michelle Hall, PhD, MSc, BSc (Hons)
About this study
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.
Read the 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.
- Conditions
- Osteo Arthritis Knee and Hip, Low Back Pain, Insomnia
- Being tested
- Aerobic physical activity, CBT-I, Combined aerobic physical activity and CBT-I
- 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
- Medical subject headings
- Low Back Pain, Sleep Initiation and Maintenance Disorders, Osteoarthritis, Hip, Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic physical activityBehavioural
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.
CBT-IBehavioural
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.
Combined aerobic physical activity and CBT-IBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic physical activity | Experimental | Not described Receives: Behavioral: Aerobic physical activity |
| CBT-I | Experimental | Cognitive behaviour therapy for insomnia Receives: Behavioral: CBT-I |
| combined aerobic physical activity and CBT-I | Experimental | combined aerobic physical activity and cognitive behaviour therapy for insomnia Receives: Behavioral: Combined aerobic physical activity and CBT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 2, 6 (primary time-point) and 12 months
Secondary outcomes (7)
Worst pain severity
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").
Measured: Baseline and 2, 6 and 12 months
Pain interference (PROMIS Short Form 8a)
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'
Measured: Baseline, 2 mths, 6 and 12 months.
Health-related quality of life (EQ-5D-5L)
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.
Measured: Baseline, 2 mths, 6 and 12 months.
Insomnia (Insomnia Severity Index)
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.
Measured: Baseline, 2 mths, 6 and 12 months.
Sleep-related impairment (PROMIS-Sleep-related Impairment Short Form 8a)
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.
Measured: Baseline, 2 mths, 6 and 12 months.
Physical Function (PROMIS-Physical Function Short Form 8c v2.0)
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.
Measured: Baseline, 2 mths, 6 and 12 months.
Satisfaction with the intervention
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.
Measured: 2 mths, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis Knee and HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Queensland, Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532070
- Sponsor's protocol ID
- 2024/HE001412
- Other IDs
- HT9425-23-CPMRP-CORA
- Acronym
- SLEEPFIT
- Status last verified
- May 2026
- First submitted
- 8 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL
- ClinicalTrials.gov ID
- NCT07532070
- Acronym / sponsor ID
- SLEEPFIT / 2024/HE001412
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- The University of Queensland, Uniformed Services University of the Health Sciences
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Aerobic physical activity | Experimental | Behavioral: Aerobic physical activity |
| CBT-I | Experimental | Behavioral: CBT-ICognitive behaviour therapy for insomnia |
| combined aerobic physical activity and CBT-I | Experimental | Behavioral: Combined aerobic physical activity and CBT-Icombined aerobic physical activity and cognitive behaviour therapy for insomnia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic physical activityThis 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. | Behavioural | Aerobic physical activity |
| CBT-IThis 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. | Behavioural | CBT-I |
| Combined aerobic physical activity and CBT-IThis 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. | Behavioural | combined aerobic physical activity and CBT-I |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic physical activity, CBT-I and Combined aerobic physical activity and CBT-I in people with Osteo Arthritis Knee and Hip and Low Back Pain, run by University of Sydney at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alan A Nguyen, BSc/B.A (+610433014884, sleepfit.trial@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Pain severity (time frame: Baseline and 2, 6 (primary time-point) and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.