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Completed

NCT Number: NCT05242848

Integrated Exercise Program in Opioid Agonist Therapy Clinics

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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Key information

Conditions

Substance-related Disorders Behavior Chemically-Induced Disorders Mental Disorders Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LAR Helse Stavanger HF, Stavanger, Rogaland, Norway

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About this study

See below each section

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Physical functioning

    Time frame: Mid of the intervention period 16 weeks after initiation

    Physical functioning assessed with 4-minutes step-test measuring numbers of steps climbed in period

  2. Physical functioning

    Time frame: Mid of the intervention period 16 weeks after initiation

    Physical functioning assessed using the Norwegian validated translation of the International physical activity questionnaire (IPAQ).

  3. Fatigue Symptom Scale

    Time frame: 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)

  4. Biochemical indicator of inflammation

    Time frame: Mid of the intervention period 16 weeks after initiation

    Biochemical indicators of inflammation measured with C-reactive protein in serum

  5. Health-related quality of life

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Helse Stavanger HF
  • Helse Vest
  • University of Bergen

Registry information

Official study title

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

Acronym: BAReAktiv

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Feb 16, 2022
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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