Clinical trial NCT05242848: Integrated Exercise Program in Opioid Agonist Therapy Clinics
Official title: Integrated Exercise in Opioid Agonist Therapy Clinics: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance-Related Disorders
Keywords: Opiate substitution Treatment
Exercise Therapy
Exercise
Substance-Related Disorders
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
name: Helse Vest
name: University of Bergen
First posted: 2022-02-16
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Psychological distress
timeFrame: Mid of the intervention period 16 weeks after initiation
Secondary outcomes:
measure: Physical functioning
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Physical functioning
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Fatigue Symptom Scale
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Biochemical indicator of inflammation
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Health-related quality of life
timeFrame: Mid of the intervention period 16 weeks after initiation
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: LAR Helse Stavanger HF
state: Rogaland
city: Bergen
country: Norway
facility: Department of Addiction Medicine, Haukeland University Hospital
state: Vestland
Study officials:
affiliation: Haukeland University Hospital
name: Lars T Fadnes, PHD
role: PRINCIPAL_INVESTIGATOR
References: