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Terminated

NCT Number: NCT04496934

Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

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.

Why the study stopped: COVID-19
Terminated

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

Primary outcomes

  1. Height and weight

    Time frame: 12 weeks

    Weight and height will be combined to report BMI in kg/m^2

  2. Endurance

    Time frame: 12 weeks

    Ventilatory threshold/VO2max (endurance test on treadmill)

  3. Strength

    Time frame: 12 weeks

    Push-ups (maximal test where the participants perform a maximum number of correct push-ups)

  4. Balance

    Time frame: 12 weeks

    Stork Balance Test (timed test where the goal is to keep one's balance as long as possible)

Secondary outcomes

  1. Alcohol use

    Time frame: 12 weeks

    AUDIT-E

  2. Drug use

    Time frame: 12 weeks

    DUDIT-E

  3. Executive functions

    Time frame: 12 weeks

    Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)

  4. Satisfaction with life

    Time frame: 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.

  5. Sleep quality

    Time frame: 12 weeks

    Pittsburgh Sleep Quality Index (PSQI)

  6. Attention

    Time frame: 12 weeks

    Connors Continuous Performance Test (CPT 3)

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Helse Stavanger HF
  • Kristiania University College
  • Solli Distriktspsykiatriske Senter
  • University of Bergen
  • Western Norway University of Applied Sciences

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 4, 2020
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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