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| Name | Class |
|---|---|
| Helse Stavanger HF | OTHER_GOV |
| Helse Vest | OTHER |
| University of Bergen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise intervention | Experimental | 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. |
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| Standard | No Intervention | Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Physical functioning |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars T Fadnes, PHD | Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAR Helse Stavanger HF | Stavanger | Rogaland | 4010 | Norway | ||
| Department of Addiction Medicine, Haukeland University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38424609 | Derived | Furulund E, Madebo T, Druckrey-Fiskaaen KT, Vold JH, Nordbotn MH, Dahl E, Dyrstad SM, Lid TG, Fadnes LT; ATLAS4LAR study group. Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv). Trials. 2024 Feb 29;25(1):155. doi: 10.1186/s13063-024-07993-2. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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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.
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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.
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Physical functioning assessed using the Norwegian validated translation of the International physical activity questionnaire (IPAQ).
| Mid of the intervention period 16 weeks after initiation |
| 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 |
| Biochemical indicator of inflammation | Biochemical indicators of inflammation measured with C-reactive protein in serum | Mid of the intervention period 16 weeks after initiation |
| 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 |
| Bergen |
| Vestland |
| 5020 |
| Norway |