Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv)
Abstract Background Substance use disorder is associated with unhealthy lifestyle choices, resulting in adverse social and health consequences. People with opioid use disorder receiving opioid agonist therapy, in particular, have high morbidity and reduced quality of life. Physical activity is recom...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-024-07993-2 |
| _version_ | 1797273376229687296 |
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| author | Einar Furulund Tesfaye Madebo Karl Trygve Druckrey-Fiskaaen Jørn Henrik Vold Mette Hegland Nordbotn Eivin Dahl Sindre M. Dyrstad Torgeir Gilje Lid Lars T. Fadnes for the ATLAS4LAR study group |
| author_facet | Einar Furulund Tesfaye Madebo Karl Trygve Druckrey-Fiskaaen Jørn Henrik Vold Mette Hegland Nordbotn Eivin Dahl Sindre M. Dyrstad Torgeir Gilje Lid Lars T. Fadnes for the ATLAS4LAR study group |
| author_sort | Einar Furulund |
| collection | DOAJ |
| description | Abstract Background Substance use disorder is associated with unhealthy lifestyle choices, resulting in adverse social and health consequences. People with opioid use disorder receiving opioid agonist therapy, in particular, have high morbidity and reduced quality of life. Physical activity is recommended as an adjunctive treatment for people with substance use disorder, but there is minimal evidence from randomized controlled trials on the effects of this among people with substance use disorder receiving opioid agonist therapy. Methods BAReAktiv is a multicentre randomized controlled trial. The study aims to recruit 324 patients receiving opioid agonist therapy (parallel groups randomized 1:1 to integrated exercise intervention or control, superiority trial). A 16-week group-based integrated exercise intervention with workouts twice a week. The exercise program consists of endurance and resistance training. The target group will be patients 18 years and older receiving opioid agonist therapy in outpatient clinics in several centers in Western Norway. The primary outcome of the study is the effect on psychological distress measured by Hopkins’ symptom checklist with ten items. Secondary outcome measures include physical functioning assessed with a 4-min step test, activity level, fatigue symptoms, quality of life, and changes in inflammation markers. This study will provide improved knowledge on the effects of an integrated exercise program in opioid agonist therapy. Discussion Systematically integrating exercise programs for people receiving opioid agonist therapy could lead to a shift towards a stronger focus on health behaviors in outpatient care. Integrating exercise could benefit patient recovery and reduce disease burden. Further scale-up will be considered if the provided exercise program is safe and effective. Trial registration ClinicalTrials.gov. NCT05242848. Registered on February 16, 2022. |
| first_indexed | 2024-03-07T14:42:31Z |
| format | Article |
| id | doaj.art-3475dda19bc8430481cf24061b573411 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-07T14:42:31Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-3475dda19bc8430481cf24061b5734112024-03-05T20:10:42ZengBMCTrials1745-62152024-02-012511910.1186/s13063-024-07993-2Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv)Einar Furulund0Tesfaye Madebo1Karl Trygve Druckrey-Fiskaaen2Jørn Henrik Vold3Mette Hegland Nordbotn4Eivin Dahl5Sindre M. Dyrstad6Torgeir Gilje Lid7Lars T. Fadnes8for the ATLAS4LAR study groupCentre for Alcohol and Drug Research, Stavanger University HospitalDepartment of Addiction Medicine, Bergen Addiction Research, Haukeland University HospitalDepartment of Addiction Medicine, Bergen Addiction Research, Haukeland University HospitalDepartment of Addiction Medicine, Bergen Addiction Research, Haukeland University HospitalDepartment of Addiction Medicine, Bergen Addiction Research, Haukeland University HospitalDepartment of Addiction, Stavanger University HospitalDepartment of Education and Sport Science, University of StavangerCentre for Alcohol and Drug Research, Stavanger University HospitalDepartment of Addiction Medicine, Bergen Addiction Research, Haukeland University HospitalAbstract Background Substance use disorder is associated with unhealthy lifestyle choices, resulting in adverse social and health consequences. People with opioid use disorder receiving opioid agonist therapy, in particular, have high morbidity and reduced quality of life. Physical activity is recommended as an adjunctive treatment for people with substance use disorder, but there is minimal evidence from randomized controlled trials on the effects of this among people with substance use disorder receiving opioid agonist therapy. Methods BAReAktiv is a multicentre randomized controlled trial. The study aims to recruit 324 patients receiving opioid agonist therapy (parallel groups randomized 1:1 to integrated exercise intervention or control, superiority trial). A 16-week group-based integrated exercise intervention with workouts twice a week. The exercise program consists of endurance and resistance training. The target group will be patients 18 years and older receiving opioid agonist therapy in outpatient clinics in several centers in Western Norway. The primary outcome of the study is the effect on psychological distress measured by Hopkins’ symptom checklist with ten items. Secondary outcome measures include physical functioning assessed with a 4-min step test, activity level, fatigue symptoms, quality of life, and changes in inflammation markers. This study will provide improved knowledge on the effects of an integrated exercise program in opioid agonist therapy. Discussion Systematically integrating exercise programs for people receiving opioid agonist therapy could lead to a shift towards a stronger focus on health behaviors in outpatient care. Integrating exercise could benefit patient recovery and reduce disease burden. Further scale-up will be considered if the provided exercise program is safe and effective. Trial registration ClinicalTrials.gov. NCT05242848. Registered on February 16, 2022.https://doi.org/10.1186/s13063-024-07993-2Opiate substitution treatmentMotor activityExercise therapySubstance-related disordersInterventionOutpatient |
| spellingShingle | Einar Furulund Tesfaye Madebo Karl Trygve Druckrey-Fiskaaen Jørn Henrik Vold Mette Hegland Nordbotn Eivin Dahl Sindre M. Dyrstad Torgeir Gilje Lid Lars T. Fadnes for the 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 Opiate substitution treatment Motor activity Exercise therapy Substance-related disorders Intervention Outpatient |
| title | Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv) |
| title_full | Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv) |
| title_fullStr | Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv) |
| title_full_unstemmed | Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv) |
| title_short | Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv) |
| title_sort | integrated exercise program in opioid agonist therapy clinics and effect on psychological distress study protocol for a randomized controlled trial bareaktiv |
| topic | Opiate substitution treatment Motor activity Exercise therapy Substance-related disorders Intervention Outpatient |
| url | https://doi.org/10.1186/s13063-024-07993-2 |
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