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Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

Sponsor
Haukeland University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04496934
Collaborator
Helse Stavanger HF (Other), Kristiania University College (Other), University of Bergen (Other), Western Norway University of Applied Sciences (Other), Solli Distriktspsykiatriske Senter (Other)
17
Enrollment
1
Location
2
Arms
24
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Physical Activity as Adjunct Treatment for Opioid Substitution Therapy
Actual Study Start Date :
Jan 30, 2018
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Jan 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Height and weight [12 weeks]

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

  2. Endurance [12 weeks]

    Ventilatory threshold/VO2max (endurance test on treadmill)

  3. Strength [12 weeks]

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

  4. Balance [12 weeks]

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

Secondary Outcome Measures

  1. Alcohol use [12 weeks]

    AUDIT-E

  2. Drug use [12 weeks]

    DUDIT-E

  3. Executive functions [12 weeks]

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

  4. 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.

  5. Sleep quality [12 weeks]

    Pittsburgh Sleep Quality Index (PSQI)

  6. Attention [12 weeks]

    Connors Continuous Performance Test (CPT 3)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haukeland University Hospital Bergen Norway

Sponsors and Collaborators

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

Investigators

  • Study Director: Asgeir Mamen, PhD, Kristiania University College

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT04496934
Other Study ID Numbers:
  • 2013/00731
First Posted:
Aug 4, 2020
Last Update Posted:
Aug 13, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Opioid-Related Disorders

Study Results

No Results Posted as of Aug 13, 2020