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Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

Primary Purpose

Opioid-use Disorder, Substance Use Disorders, Opioid Dependence

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Exercise intervention

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

Outcomes

Primary Outcome Measures

Height and weight
Weight and height will be combined to report BMI in kg/m^2
Endurance
Ventilatory threshold/VO2max (endurance test on treadmill)
Strength
Push-ups (maximal test where the participants perform a maximum number of correct push-ups)
Balance
Stork Balance Test (timed test where the goal is to keep one's balance as long as possible)

Secondary Outcome Measures

Alcohol use
AUDIT-E
Drug use
DUDIT-E
Executive functions
Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
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.
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Attention
Connors Continuous Performance Test (CPT 3)

Full Information

First Posted
October 25, 2018
Last Updated
August 11, 2020
Sponsor
Haukeland University Hospital
Collaborators
Helse Stavanger HF, Kristiania University College, University of Bergen, Western Norway University of Applied Sciences, Solli Distriktspsykiatriske Senter
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1. Study Identification

Unique Protocol Identification Number
NCT04496934
Brief Title
Physical Activity as Adjunct Treatment for Opioid Substitution Therapy
Official Title
Physical Activity as Adjunct Treatment for Opioid Substitution Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Helse Stavanger HF, Kristiania University College, University of Bergen, Western Norway University of Applied Sciences, Solli Distriktspsykiatriske Senter

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Substance Use Disorders, Opioid Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Exercise intervention
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group is a waiting list group. The participants will receive exercise intervention after twelve weeks of treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Exercise of choice with a training contact: 3 hrs/week, total of 12 weeks.
Primary Outcome Measure Information:
Title
Height and weight
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
12 weeks
Title
Endurance
Description
Ventilatory threshold/VO2max (endurance test on treadmill)
Time Frame
12 weeks
Title
Strength
Description
Push-ups (maximal test where the participants perform a maximum number of correct push-ups)
Time Frame
12 weeks
Title
Balance
Description
Stork Balance Test (timed test where the goal is to keep one's balance as long as possible)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Alcohol use
Description
AUDIT-E
Time Frame
12 weeks
Title
Drug use
Description
DUDIT-E
Time Frame
12 weeks
Title
Executive functions
Description
Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Time Frame
12 weeks
Title
Satisfaction with life
Description
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.
Time Frame
12 weeks
Title
Sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
12 weeks
Title
Attention
Description
Connors Continuous Performance Test (CPT 3)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asgeir Mamen, PhD
Organizational Affiliation
Kristiania University College
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

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