Integrated Exercise Program in Opioid Agonist Therapy Clinics

Substance-Related Disorders Clinical Trial

— BAReAktiv  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05242848
• Other study ID #: 155386/REK-C
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See below each section

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 324
• Est. completion date: December 2026
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Norway	Department of Addiction Medicine, Haukeland University Hospital	Bergen	Vestland
Norway	LAR Helse Stavanger HF	Stavanger	Rogaland

Sponsors (4)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Stavanger HF, Helse Vest, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological distress	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.	Mid of the intervention period 16 weeks after initiation
Secondary	Physical functioning	Physical functioning assessed with 4-minutes step-test measuring numbers of steps climbed in period	Mid of the intervention period 16 weeks after initiation
Secondary	Physical functioning	Physical functioning assessed using the Norwegian validated translation of the International physical activity questionnaire (IPAQ).	Mid of the intervention period 16 weeks after initiation
Secondary	Fatigue Symptom Scale	Changes in fatigue will be assessed with the Fatigue Symptom Scale (FSS-3, 0-18, higher is worse)	Mid of the intervention period 16 weeks after initiation
Secondary	Biochemical indicator of inflammation	Biochemical indicators of inflammation measured with C-reactive protein in serum	Mid of the intervention period 16 weeks after initiation
Secondary	Health-related quality of life	Changes in quality of life will be assessed with EuroQoL five dimensions (EQ-5D-5L, 0-100, higher is better)	Mid of the intervention period 16 weeks after initiation

External Links

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