Integrated Exercise Program in Opioid Agonist Therapy Clinics (BAReAktiv)

• ClinicalTrials.gov Identifier: NCT05242848
• Recruitment Status: Active, not recruiting
• First Posted: February 16, 2022
• Last Update Posted: October 17, 2023
• Sponsor: Haukeland University Hospital
• Collaborators: Helse Stavanger HF; Helse Vest; University of Bergen
• Information provided by (Responsible Party): Haukeland University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Substance-Related Disorders	Behavioral: Exercise intervention	Not Applicable

Detailed Description:

See below each section

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 324 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model 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.
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Integrated Exercise in Opioid Agonist Therapy Clinics: A Randomised Controlled Trial
• Actual Study Start Date: April 7, 2022
• Estimated Primary Completion Date: October 2023
• Estimated Study Completion Date: December 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Standard; Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Norway

LAR Helse Stavanger HF

Stavanger, Rogaland, Norway, 4010

Department of Addiction Medicine, Haukeland University Hospital

Bergen, Vestland, Norway, 5020

Sponsors and Collaborators

Haukeland University Hospital

Helse Stavanger HF

Helse Vest

University of Bergen

Investigators

• Principal Investigator: Lars T Fadnes, PHD; Haukeland University Hospital

More Information

Additional Information:

Related Info 

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT05242848
• Other Study ID Numbers: 155386/REK-C
• First Posted: February 16, 2022
• Last Update Posted: October 17, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haukeland University Hospital:

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

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders