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Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04496934
Enrollment
17
Registered
2020-08-04
Start date
2018-01-30
Completion date
2030-12-31
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Dependence, Opioid-use Disorder, Substance Use Disorders

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.

Interventions

BEHAVIORALExercise

Exercise of choice with a training contact: 3 hrs/week, total of 12 weeks.

Sponsors

Helse Stavanger HF
CollaboratorOTHER_GOV
Kristiania University College
CollaboratorOTHER
University of Bergen
CollaboratorOTHER
Western Norway University of Applied Sciences
CollaboratorOTHER
Solli Distriktspsykiatriske Senter
CollaboratorOTHER
Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Pregnancy * Being in opioid substitution program for less than three months

Design outcomes

Primary

MeasureTime frameDescription
Height and weight12 weeksWeight and height will be combined to report BMI in kg/m\^2
Endurance12 weeksVentilatory threshold/VO2max (endurance test on treadmill)
Strength12 weeksPush-ups (maximal test where the participants perform a maximum number of correct push-ups)
Balance12 weeksStork Balance Test (timed test where the goal is to keep one's balance as long as possible)

Secondary

MeasureTime frameDescription
Sleep quality12 weeksPittsburgh Sleep Quality Index (PSQI)
Alcohol use12 weeksAUDIT-E
Attention12 weeksConnors Continuous Performance Test (CPT 3)
Drug use12 weeksDUDIT-E
Executive functions12 weeksBehavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Satisfaction with life12 weeksSatisfaction 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026