Substance-Related DisordersBAReAktivNCT05242848
Integrated Exercise Program in Opioid Agonist Therapy Clinics
A study testing Exercise intervention in people with Substance-Related Disorders, run by Haukeland University Hospital at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 2 sitesNorway
- Study dates
- 7 Apr 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not able to participate in the intervention due to physical disabilities or severe mental disorders
- Being imprisoned or in inpatient treatment settings
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Department of Addiction Medicine, Haukeland University Hospital
Bergen, Vestland, 5020
LAR Helse Stavanger HF
Stavanger, Rogaland, 4010
About this study
Official title: Integrated Exercise in Opioid Agonist Therapy Clinics: A Randomised Controlled Trial
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.
Read more
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.
Read the detailed description
See below each section
- Conditions
- Substance-Related Disorders
- Being tested
- Exercise intervention
- Keywords
- Opiate substitution Treatment, Exercise Therapy, Exercise, Substance-Related Disorders
- Medical subject headings
- Substance-Related Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise intervention |
| Standard | No intervention | Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Mid of the intervention period 16 weeks after initiation
Secondary outcomes (5)
Physical functioning
Physical functioning assessed with 4-minutes step-test measuring numbers of steps climbed in period
Measured: Mid of the intervention period 16 weeks after initiation
Physical functioning
Physical functioning assessed using the Norwegian validated translation of the International physical activity questionnaire (IPAQ).
Measured: 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)
Measured: Mid of the intervention period 16 weeks after initiation
Biochemical indicator of inflammation
Biochemical indicators of inflammation measured with C-reactive protein in serum
Measured: 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)
Measured: Mid of the intervention period 16 weeks after initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start7 Apr 2022
- Primary completion1 Oct 2023
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF, Helse Vest, University of Bergen
- Responsible party
- Sponsor
- Investigators
- Lars T Fadnes, PHD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242848
- Sponsor's protocol ID
- 155386/REK-C
- Acronym
- BAReAktiv
- Status last verified
- Aug 2025
- First submitted
- 7 Feb 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38424609
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Exercise in Opioid Agonist Therapy Clinics: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05242848
- Acronym / sponsor ID
- BAReAktiv / 155386/REK-C
- Conditions
- Substance-Related Disorders
- Keywords
- Opiate substitution Treatment, Exercise Therapy, Exercise, Substance-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Stavanger HF, Helse Vest, University of Bergen
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: Exercise interventionThe 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. |
| Standard | No intervention | –Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Not able to participate in the intervention due to physical disabilities or severe mental disorders
- Being imprisoned or in inpatient treatment settings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionThe 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. | Behavioural | Exercise intervention |
Primary outcome
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.
5 secondary outcomes
Physical functioning
Time frame: Mid of the intervention period 16 weeks after initiation
Physical functioning
Time frame: Mid of the intervention period 16 weeks after initiation
Fatigue Symptom Scale
Time frame: Mid of the intervention period 16 weeks after initiation
Biochemical indicator of inflammation
Time frame: Mid of the intervention period 16 weeks after initiation
Health-related quality of life
Time frame: Mid of the intervention period 16 weeks after initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Derived from this study: PubMed 38424609Furulund 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Substance-Related Disorders
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars T Fadnes, PHD principal investigator
Haukeland University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Substance-Related Disorders, run by Haukeland University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (time frame: Mid of the intervention period 16 weeks after initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05242848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.