Physical Activity as Adjunct Treatment for Opioid Substitution Therapy
- Conditions
- Substance Use DisordersOpioid-use DisorderOpioid Dependence
- Interventions
- Behavioral: Exercise
- Registration Number
- NCT04496934
- Lead Sponsor
- Haukeland University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 17
- 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
- Pregnancy
- Being in opioid substitution program for less than three months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Exercise Exercise intervention Control Exercise The control group is a waiting list group. The participants will receive exercise intervention after twelve weeks of treatment as usual.
- Primary Outcome Measures
Name Time Method Height and weight 12 weeks Weight and height will be combined to report BMI in kg/m\^2
Endurance 12 weeks Ventilatory threshold/VO2max (endurance test on treadmill)
Strength 12 weeks Push-ups (maximal test where the participants perform a maximum number of correct push-ups)
Balance 12 weeks Stork Balance Test (timed test where the goal is to keep one's balance as long as possible)
- Secondary Outcome Measures
Name Time Method Drug use 12 weeks DUDIT-E
Executive functions 12 weeks Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Satisfaction with life 12 weeks Satisfaction With Life Scale (SWLS)
Values/scores:
* 7 - Strongly agree
* 6 - Agree
* 5 - Slightly agree
* 4 - Neither agree nor disagree
* 3 - Slightly disagree
* 2 - Disagree
* 1 - Strongly disagree
Results (sum of scores/values):
31 - 35 Extremely satisfied 26 - 30 Satisfied 21 - 25 Slightly satisfied 20 Neutral 15 - 19 Slightly dissatisfied 10 - 14 Dissatisfied 5 - 9 Extremely dissatisfied The higher the score the better the outcome.Sleep quality 12 weeks Pittsburgh Sleep Quality Index (PSQI)
Attention 12 weeks Connors Continuous Performance Test (CPT 3)
Alcohol use 12 weeks AUDIT-E
Trial Locations
- Locations (1)
Haukeland University Hospital
🇳🇴Bergen, Norway