Integrated Exercise Program in Opioid Agonist Therapy Clinics

NCT05242848 | Completed

• 1 other identifier: 155386/REK-C
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance-Related Disorders

Keywords

Opiate substitution Treatment; Exercise Therapy; Exercise; Substance-Related Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Physical functioning

  Mid of the intervention period 16 weeks after initiation

• Physical functioning

  Mid of the intervention period 16 weeks after initiation

• Fatigue Symptom Scale

  Mid of the intervention period 16 weeks after initiation

• Biochemical indicator of inflammation

  Mid of the intervention period 16 weeks after initiation

• Health-related quality of life

  Mid of the intervention period 16 weeks after initiation

Study Arms (2)

Exercise intervention

EXPERIMENTAL

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

Standard

NO INTERVENTION

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

Interventions

Exercise intervention 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.

Exercise intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not able to participate in the intervention due to physical disabilities or severe mental disorders
• Being imprisoned or in inpatient treatment settings

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Helse Stavanger HF: collaborator
• Helse Vest: collaborator
• University of Bergen: collaborator

Study Sites (2)

LAR Helse Stavanger HF

Stavanger, Rogaland, 4010, Norway

Location

Department of Addiction Medicine, Haukeland University Hospital

Bergen, Vestland, 5020, Norway

Location

Related Publications (1)

• Furulund E, Madebo T, Druckrey-Fiskaaen KT, Vold JH, Nordbotn MH, Dahl E, Dyrstad SM, Lid TG, Fadnes LT; ATLAS4LAR study group. Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv). Trials. 2024 Feb 29;25(1):155. doi: 10.1186/s13063-024-07993-2.

  PMID: 38424609 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Substance-Related Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Lars T Fadnes, PHD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 16, 2022
• Study Start: April 7, 2022
• Primary Completion: October 1, 2023
• Study Completion: March 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)