Integrated Exercise Program in Opioid Agonist Therapy Clinics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

309 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2025-03-01

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.

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Detailed Description

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See below each section

Conditions

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Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Exercise intervention

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.

Group Type EXPERIMENTAL

Exercise intervention

Intervention Type BEHAVIORAL

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.

Standard

Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise intervention

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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No