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

Tracking Information

• First Submitted Date: February 7, 2022
• First Posted Date: February 16, 2022
• Last Update Posted Date: October 17, 2023
• Actual Study Start Date: April 7, 2022
• Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 7, 2022)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 7, 2022)

• 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
• 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).
• 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)
• 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
• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Integrated Exercise Program in Opioid Agonist Therapy Clinics
• Official Title: Integrated Exercise in Opioid Agonist Therapy Clinics: A Randomised Controlled Trial

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.

• Detailed Description: See below each section
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Substance-Related Disorders

Intervention

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.

Study Arms

• 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.
  Intervention: Behavioral: Exercise intervention
• No Intervention: Standard
  Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 16, 2023): 324
• Original Estimated Enrollment (submitted: February 7, 2022): 216
• Estimated Study Completion Date: December 2026
• Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT05242848
• Other Study ID Numbers: 155386/REK-C
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Haukeland University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Haukeland University Hospital
• Original Study Sponsor: Same as current

Collaborators

• Helse Stavanger HF
• Helse Vest
• University of Bergen

Investigators

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

• PRS Account: Haukeland University Hospital
• Verification Date: October 2023