Integrated Exercise Program in Opioid Agonist Therapy Clinics
- Conditions
- Substance-Related Disorders
- Registration Number
- NCT05242848
- Lead Sponsor
- Haukeland University Hospital
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 309
- 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
- Not able to participate in the intervention due to physical disabilities or severe mental disorders
- Being imprisoned or in inpatient treatment settings
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Psychological distress 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 Outcome Measures
Name Time Method Biochemical indicator of inflammation Mid of the intervention period 16 weeks after initiation Biochemical indicators of inflammation measured with C-reactive protein in serum
Fatigue Symptom Scale Mid of the intervention period 16 weeks after initiation Changes in fatigue will be assessed with the Fatigue Symptom Scale (FSS-3, 0-18, higher is worse)
Physical functioning Mid of the intervention period 16 weeks after initiation Physical functioning assessed using the Norwegian validated translation of the International physical activity questionnaire (IPAQ).
Health-related quality of life Mid of the intervention period 16 weeks after initiation Changes in quality of life will be assessed with EuroQoL five dimensions (EQ-5D-5L, 0-100, higher is better)
Trial Locations
- Locations (2)
LAR Helse Stavanger HF
🇳🇴Stavanger, Rogaland, Norway
Department of Addiction Medicine, Haukeland University Hospital
🇳🇴Bergen, Vestland, Norway
LAR Helse Stavanger HF🇳🇴Stavanger, Rogaland, Norway