Physical Activity as Adjunct Treatment for Opioid Substitution Therapy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Height and weight
研究概览
简要总结
In terms of research, it is documented that exercise has a positive effect on mental disorders. Studies have shown positive correlations between physical and mental health, also among substance users. Such a study has never been performed on patients in opioid substitution therapy (OST). Documentation on the physical health of patients and the effect of exercise is very limited. Treatment of substance users is a research area with insufficient knowledge about certain treatment effects. It is important that a treatment can both support and promote the user's own resources and efforts to change their habits of substance use.
The objective of this project is to examine the effect of exercise for OST patients, measured in relation to cognitive function and physical form. The target group consists of OST patients from 18 years of age and up, of both sexes, and on stable medication. At least 60 participants should complete the project, which is designed as a controlled randomized study (RCT). Participants in the intervention group start to exercise immediately after baseline testing. Participants in the control group are on a waiting list and will start to exercise after twelve weeks. Both groups undergo testing at baseline, after three, six and 12 months. Testing consists of two parts: A battery of cognitive and psychosocial assessments and an assessment of physical variables.
The research questions of this project are important in a public health perspective. Generated knowledge can be quickly applied to local treatment institutions in Norway.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must sign a informed consent form
- •Must be participating in an opioid substitution program
- •Must be on a steady fixed dose of medication
- •Must be at least 18 years of age
排除标准
- •Pregnancy
- •Being in opioid substitution program for less than three months
结局指标
主要结局
Height and weight
时间窗: 12 weeks
Weight and height will be combined to report BMI in kg/m\^2
Endurance
时间窗: 12 weeks
Ventilatory threshold/VO2max (endurance test on treadmill)
Strength
时间窗: 12 weeks
Push-ups (maximal test where the participants perform a maximum number of correct push-ups)
Balance
时间窗: 12 weeks
Stork Balance Test (timed test where the goal is to keep one's balance as long as possible)
次要结局
- Drug use(12 weeks)
- Alcohol use(12 weeks)
- Executive functions(12 weeks)
- Satisfaction with life(12 weeks)
- Sleep quality(12 weeks)
- Attention(12 weeks)