Integrated Exercise Program in Opioid Agonist Therapy Clinics

Study Overview
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Brief Summary
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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
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See below each section

Official Title
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Integrated Exercise in Opioid Agonist Therapy Clinics: A Randomised Controlled Trial

Conditions
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Substance-Related Disorders

Intervention / Treatment
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* Behavioral: Exercise intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention is a supervised group-based exercise intervention for 16 weeks, including two outdoor sessions per week. The workout consists of two parts, endurance and a strength training segment. Every workout follows the same structure and lasts approximately 45 minutes. The exercise starts with roughly 15 minutes of endurance warm-up. After the warm-up follows the interval with eight repetitions of 30 seconds uphill, and the participants can freely choose between walking or running. The desired intensity of the intervals is >13 on Borg-score 20. The session will end with four specific exercises focusing on strength training of large muscle groups, including mm. pectoralis major, rectus abdominis, quadriceps femoris, gluteus maximus and latissimus dorsi. The strength training program follows the same structure as the intervals. Clinical staff, research staff, and people with user experience will supervise the exercise sessions.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise intervention<br>The intervention is a supervised group-based exercise intervention for 16 weeks, including two outdoor sessions per week. The workout consists of two parts, endurance and a strength training segment. Every workout follows the same structure and lasts approximately 45 minutes. The exercise starts with roughly 15 minutes of endurance warm-up. After the warm-up follows the interval with eight repetitions of 30 seconds uphill, and the participants can freely choose between walking or running. The desired intensity of the intervals is >13 on Borg-score 20. The session will end with four specific exercises focusing on strength training of large muscle groups, including mm. pectoralis major, rectus abdominis, quadriceps femoris, gluteus maximus and latissimus dorsi. The strength training program follows the same structure as the intervals. Clinical staff, research staff, and people with user experience will supervise the exercise sessions. | Behavioral: Exercise intervention<br>* The intervention is a supervised group-based exercise intervention for 16 weeks, including two outdoor sessions per week. The workout consists of two parts, endurance and a strength training segment. Every workout follows the same structure and lasts approximately 45 minutes. The exercise starts with roughly 15 minutes of endurance warm-up. After the warm-up follows the interval with eight repetitions of 30 seconds uphill, and the participants can freely choose between walking or running. The desired intensity of the intervals is >13 on Borg-score 20. The session will end with four specific exercises focusing on strength training of large muscle groups, including mm. pectoralis major, rectus abdominis, quadriceps femoris, gluteus maximus and latissimus dorsi. The strength training program follows the same structure as the intervals. Clinical staff, research staff, and people with user experience will supervise the exercise sessions.<br>|
| No Intervention: Standard<br>Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological distress | 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. | Mid of the intervention period 16 weeks after initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical functioning | Physical functioning assessed with 4-minutes step-test measuring numbers of steps climbed in period | Mid of the intervention period 16 weeks after initiation | 
| Physical functioning | Physical functioning assessed using the Norwegian validated translation of the International physical activity questionnaire (IPAQ). | Mid of the intervention period 16 weeks after initiation | 
| Fatigue Symptom Scale | Changes in fatigue will be assessed with the Fatigue Symptom Scale (FSS-3, 0-18, higher is worse) | Mid of the intervention period 16 weeks after initiation | 
| Biochemical indicator of inflammation | Biochemical indicators of inflammation measured with C-reactive protein in serum | Mid of the intervention period 16 weeks after initiation | 
| Health-related quality of life | Changes in quality of life will be assessed with EuroQoL five dimensions (EQ-5D-5L, 0-100, higher is better) | Mid of the intervention period 16 weeks after initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opiate substitution Treatment, Exercise Therapy, Exercise, Substance-Related Disorders