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临床试验/NCT05242848
NCT05242848已完成不适用

Integrated Exercise in Opioid Agonist Therapy Clinics: A Randomised Controlled Trial

Haukeland University Hospital4 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2022年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
309
试验地点
4
主要终点
Psychological distress

研究概览

简要总结

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.

详细描述

See below each section

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Not able to participate in the intervention due to physical disabilities or severe mental disorders
  • Being imprisoned or in inpatient treatment settings

结局指标

主要结局

Psychological distress

时间窗: 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.

次要结局

  • Biochemical indicator of inflammation(Mid of the intervention period 16 weeks after initiation)
  • Fatigue Symptom Scale(Mid of the intervention period 16 weeks after initiation)
  • Health-related quality of life(Mid of the intervention period 16 weeks after initiation)
  • Physical functioning(Mid of the intervention period 16 weeks after initiation)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (4)

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