Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

NCT04496934 | Suspended

• 1 other identifier: 2013/00731
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder; Substance Use Disorders; Opioid Dependence

Outcome Measures

Primary Outcomes (4)

• Height and weight

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

  12 weeks

• Endurance

  Ventilatory threshold/VO2max (endurance test on treadmill)

  12 weeks

• Strength

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

  12 weeks

• Balance

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

  12 weeks

Secondary Outcomes (6)

• Alcohol use

  12 weeks

• Drug use

  12 weeks

• Executive functions

  12 weeks

• Satisfaction with life

  12 weeks

• Sleep quality

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Exercise intervention

Behavioral: Exercise

Control

ACTIVE COMPARATOR

The control group is a waiting list group. The participants will receive exercise intervention after twelve weeks of treatment as usual.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Helse Stavanger HF: collaborator
• Kristiania University College: collaborator
• University of Bergen: collaborator
• Western Norway University of Applied Sciences: collaborator
• Solli Distriktspsykiatriske Senter: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Asgeir Mamen, PhD

  Kristiania University College

  STUDY DIRECTOR

• Lars Thore Fadnes, PhD

  University of Bergen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: August 4, 2020
• Study Start: January 30, 2018
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)