384 Participants NeededMy employer runs this trial

Exercise + CBT for Chronic Pain

(SLEEPFIT Trial)

Recruiting at 3 trial locations
MH
AA
Overseen ByAlan A Nguyen, BSc/B.A
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Sydney
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which non-medication treatment is most effective for individuals with chronic musculoskeletal pain, such as back pain or arthritis, who also experience sleep difficulties. Participants will join one of three groups to engage in aerobic physical activity (exercise), cognitive behavioral therapy for insomnia (CBT-I), or a combination of both. The trial includes online sessions with a physiotherapist and guidance on managing pain and sleep. It seeks individuals who have experienced significant pain and sleep issues, have not been very active recently, and can access online consultations. The goal is to improve pain management and sleep quality without relying on medication. As an unphased trial, this study offers the opportunity to explore innovative treatments that could enhance participants' quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on non-medication treatments for pain and sleep problems.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both aerobic exercise and cognitive behavioral therapy for insomnia (CBT-I) are generally safe and well-tolerated. Aerobic exercise, such as walking or cycling, can reduce pain and enhance physical abilities in individuals with chronic pain. Problems rarely occur when exercises are performed at a low-to-moderate level, such as 50-60% of maximum heart rate.

Similarly, CBT-I can improve sleep quality for those with insomnia and chronic pain. Studies have found it helps with sleep issues and can slightly reduce pain, with few side effects. Researchers have also studied the combination of CBT-I with exercise. This combination is safe and can lead to small to moderate improvements in pain relief and daily activities.

Overall, evidence supports the safety of these treatments, making them promising options for managing chronic pain and sleep problems without medication.12345

Why are researchers excited about this trial?

Researchers are excited about the treatments being tested for chronic pain because they combine physical and mental health strategies in unique ways. Unlike typical pain management options like medication or standard physical therapy, these treatments explore the use of aerobic physical activity and cognitive behavior therapy for insomnia (CBT-I) individually and together. Aerobic exercise is known to boost overall physical health and release endorphins, which can naturally alleviate pain. Meanwhile, CBT-I targets sleep-related issues, which often exacerbate chronic pain. The combination of physical activity with CBT-I is particularly promising because it simultaneously tackles physical discomfort and mental stressors that contribute to pain, potentially offering a more holistic approach to managing chronic pain.

What evidence suggests that this trial's treatments could be effective for chronic pain?

This trial will evaluate the effects of different treatments for chronic pain. Studies have shown that regular aerobic exercise, which participants in one arm of this trial will receive, can help reduce long-term pain and improve physical abilities. Research suggests that exercising 3–6 times a week provides the best pain relief. Another arm of this trial will involve Cognitive Behavioral Therapy for Insomnia (CBT-I), which has been proven to greatly improve sleep quality and reduce pain and disability for those with sleep problems. The trial also includes a combined treatment arm, where participants will receive both aerobic exercise and CBT-I. Combining these treatments may improve overall health, although it might not be significantly more effective for pain relief than using each method separately. Together, these treatments could help manage ongoing muscle and joint pain and sleep issues.13678

Are You a Good Fit for This Trial?

This trial is for adults with ongoing low back, hip, or knee pain (like osteoarthritis) and trouble sleeping. Participants must have moderate pain and sleep issues, be able to join online sessions, use the internet, and not already do regular exercise or CBT-I. Some health conditions or recent surgeries/injections may exclude people.

Inclusion Criteria

I am willing and able to join video consultations.
I am 18 or older with ongoing back pain and hip or knee osteoarthritis affecting my daily life.
My average pain level has been 4 or higher out of 10 in the past week.
See 3 more

Exclusion Criteria

Self-report engagement in >120 minutes per week of at least moderate intensity physical activity within the past 6 months
I have done CBT-I therapy within the last 6 months.
Cognitive impairment based on ≥7 on the Short Orientation Memory Concentration Test
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are 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.

12 months
Up to 10 online sessions

Follow-up

Participants are monitored for changes in pain, sleep quality, and overall health using questionnaires, wearable devices, sensory tests, and blood samples.

4 weeks
Assessments at baseline, 2 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Aerobic physical activity
  • CBT-I
  • Combined aerobic physical activity and CBT-I

Trial Overview

The study compares three home-based programs over 12 months: aerobic exercise alone, cognitive behavioral therapy for insomnia (CBT-I), or a combination of both. Participants are randomly assigned to one group and get up to 10 online sessions with a physiotherapist.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: combined aerobic physical activity and CBT-IExperimental Treatment1 Intervention
Group II: CBT-IExperimental Treatment1 Intervention
Group III: Aerobic physical activityExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Sydney

Lead Sponsor

Trials
208
Recruited
417,000+

Uniformed Services University of the Health Sciences

Collaborator

Trials
130
Recruited
91,100+

The University of Queensland

Collaborator

Trials
149
Recruited
71,700+

Citations

Physical activity and exercise for chronic pain in adults - PMC

There was evidence that physical activity reduced the severity of pain, improved physical function, and had a variable effect on both psychological function and ...

The effectiveness of aerobic exercise for pain management in ...

Overall, our results indicate that aerobic exercise is effective for pain management in patients with fibromyalgia.

Aerobic Fitness and Chronic Low Back Pain

They concluded that there is reliable evidence that aerobic exercise can help ease chronic pain, as well as help to improve the physical and ...

The effectiveness of aerobic exercise on pain and disability in ...

Aerobic exercise (AE) was shown to be equally effective as other active treatment modalities in reducing neck pain, although the overall ...

Frequency of Aerobic Exercise and Association with Pain ...

The results indicated that an exercise frequency of 3–6 times per week was most strongly associated with a reduction in pain severity, pain interference, and ...

The Role of Physical Exercise in Chronic Musculoskeletal Pain

Performing aerobic exercise at a low-to-moderate intensity of 50–60% of the maximum heart rate has an analgesic effect in chronic pain pathology [82].

Physical activity and exercise for chronic pain in adults

relevant statistical data for the primary and secondary outcomes. This included: • obtaining 50% pain relief (participant-reported);. 6. Physical activity and ...

Integrative Physical Activity and Exercise to Address Acute ...

Treatment: Several reviews have demonstrated physical activity and exercise lead to favorable improvements in self-reported pain, physical ...