Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05242848
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-17
First Post:
2022-02-07
Brief Title:
Integrated Exercise Program in Opioid Agonist Therapy Clinics
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
Integrated Exercise in Opioid Agonist Therapy Clinics A Randomised Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAReAktiv
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 outpatients 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
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 outpatients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None