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.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders; Opioid Dependence; Opioid-use Disorder
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Exercise intervention	Behavioral: Exercise; Exercise of choice with a training contact: 3 hrs/week, total of 12 weeks.
ACTIVE_COMPARATOR: Control; The control group is a waiting list group. The participants will receive exercise intervention after twelve weeks of treatment as usual.	Behavioral: Exercise; Exercise of choice with a training contact: 3 hrs/week, total of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol use	AUDIT-E	12 weeks
Drug use	DUDIT-E	12 weeks
Executive functions	Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)	12 weeks
Satisfaction with life	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.	12 weeks
Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	12 weeks
Attention	Connors Continuous Performance Test (CPT 3)	12 weeks

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen; Helse Stavanger HF; Western Norway University of Applied Sciences; Kristiania University College; Solli Distriktspsykiatriske Senter
• Investigators: Study Director: Asgeir Mamen, PhD, Kristiania University College

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2018
• Primary Completion (ACTUAL): January 31, 2020
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (ACTUAL): August 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Disease; Opioid-Related Disorders
• Other Study ID Numbers: 2013/00731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No