Integrated Exercise in Opioid Agonist Therapy Clinics: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 309
- Locations
- 4
- Primary Endpoint
- Psychological distress
Study Overview
Brief Summary
Background: Drug use is associated with unhealthy lifestyle choices, resulting in adverse social and health consequences. Particular people with opioid dependence have high morbidity and reduced quality of life. A reduction in fitness level for people with substance use disorder reduces the general health and quality of life. Physical activity is recommended as an adjunctive treatment for people with substance use disorder. Due to its positive effects on health, quality of life and substance use. There is minimal evidence from well-controlled randomised trials among people receiving opioid agonist therapy. However, studies indicate that exercise could be promising in opioid agonist therapy.
Study design: BAReAktiv is a multicentre randomised controlled trial. The study aims to recruit approximately 225 patients receiving opioid agonist therapy.
Intervention: A 16-week group-based exercise intervention with workouts twice a week. The exercise program will consist of endurance and strength training. The intervention will be integrated into outpatient's clinics in Bergen and Stavanger, Norway.
Study population: The target group will be patients over 18 years of age with severe opioid use disorder receiving OAT in outpatient clinics.
Expected outcome: This study will inform the relative advantages and disadvantages of an integrated exercise program as an adjunctive treatment. Both physical and mental health outcomes are of interest. Further scale-up will be considered if the provided exercise program is safe and effective.
Detailed Description
See below each section
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Blinding is regarded as difficult and infeasible. Patients will be informed of the follow-up they will receive, but not on other follow-up alternatives that are used or the exact hypotheses for the study. Outcomes assessor will be blinded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Receiving OAT from an included outpatient clinic with follow-up weekly
- •Low level of physical activity measured using IPAQ (assessed at screening)
- •Confirming interest in participating in physical activity intervention and providing informed consent (criteria specified)
- •Giving informed consent
Exclusion Criteria
- •Not able to participate in the intervention due to physical disabilities or severe mental disorders
- •Being imprisoned or in inpatient treatment settings
Outcomes
Primary Outcomes
Psychological distress
Time Frame: Mid of the intervention period 16 weeks after initiation
The primary outcome is psychological distress assessed with the Norwegian validated translation ten item version of Hopkins Symptom Checklist (SCL-10) in the mid of the intervention period 16 weeks after initiation (12-20). This will be evaluated with mean SCL-10 item score and compared between intervention and control arm.
Secondary Outcomes
- Biochemical indicator of inflammation(Mid of the intervention period 16 weeks after initiation)
- Fatigue Symptom Scale(Mid of the intervention period 16 weeks after initiation)
- Health-related quality of life(Mid of the intervention period 16 weeks after initiation)
- Physical functioning(Mid of the intervention period 16 weeks after initiation)