NCT05242848: BAReAktiv

Integrated Exercise Program in Opioid Agonist Therapy Clinics

Completed NA Last updated 8 August 2025

What this trial tests

NA trial testing Exercise intervention in Substance-Related Disorders in 309 participants. Completed in 1 March 2025.

Timeline

7 April 2022

Primary endpoint
1 October 2023

1 March 2025

Quick facts

Lead sponsor	Haukeland University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	309
Start date	7 April 2022
Primary completion	1 October 2023
Estimated completion	1 March 2025
Sites	2 locations across Norway

Drugs / interventions tested

• Exercise intervention

Conditions studied

• Substance-Related Disorders — all drugs for Substance-Related Disorders →

Sponsor

Haukeland University Hospital

Who can join

18 and older, any sex, with Substance-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv).
   Furulund E, Madebo T, Druckrey-Fiskaaen KT, Vold JH, et al · · 2024 · cited 1× · PMID 38424609 · DOI 10.1186/s13063-024-07993-2
2. Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: Study protocol for a randomised controlled trial (BAReAktiv)
   Furulund E, Madebo T, Druckrey-Fiskaaen KT, Vold JH, et al · · 2022 · DOI 10.21203/rs.3.rs-1693049/v1