Integrated Exercise Program in Opioid Agonist Therapy Clinics (BAReAktiv)

Haukeland University Hospital

Status: Completed

Conditions: Substance-Related Disorders

Treatments: Behavioral: Exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05242848

155386/REK-C

Details and patient eligibility

About

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.

Full description

See below each section

Enrollment: 309 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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309 participants in 2 patient groups

Exercise intervention

Experimental group

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.

Treatment:

Behavioral: Exercise intervention

Standard

No Intervention group

Description:

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