NCT04141202

Brief Summary

In 2017, structured physical exercise with high intensity was implemented as a part of the treatment program at St. Olav Hospital Clinic of Substance Use and Addiction Medicine. The objective of this study is to examine whether implementing structured physical exercise in the treatment program has implications for patients' physical and mental health and quality of life after completing a 3 month residential treatment program. The results of this study will benefit substance use disorder patients in the future, and may have an impact on further implementation of physical exercise in addiction treatment clinics both nationally and internationally.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 25, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

5.8 years

First QC Date

October 24, 2019

Last Update Submit

June 4, 2025

Conditions

Keywords

Exercise therapyExercise physiology

Outcome Measures

Primary Outcomes (3)

  • Physical health

    Change in oxygen uptake

    18 months

  • Physical health

    Change in maximum leg strength

    18 months

  • Mental health

    assessed by a in-house developed questionnaire, which is composed of 4 parts: Severity of Dependence 5-items (each of the five items is scored on a 4-point scale (0-3). Total score is the sum of the 5-item ratings. The higher the score the higher the level of dependence); Circumstances, Motivation, Readiness, and Suitability instrument (Five items measured on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (totally agree). High scores indicate increased intrinsic motivation); Quality-of-Life rating five items recorded on a five-point Likert scale: 1 (very poor) - 5 (very good). The raw scores are transformed to a decimal scale, ranging from 0.1 worst score to 0.9 best score); Hopkins Symptom Checklist (HSCL-10): Ten items recorded on a four-point Likert scale: (1) not at all - (4) extremely.

    18 months

Study Arms (1)

Exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosed with substance use disorder.

You may qualify if:

  • Being an inpatient at the clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital HF Klinikk for rus og avhengighetsmedisin

Trondheim, 7010, Norway

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Kristin Smedsrud

    St Olavs Hospital Klinikk for rus- og avhengighetsmedisin

    STUDY DIRECTOR

Central Study Contacts

Grete Flemmen, phd

CONTACT

Henrik Loe, phd

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2019

First Posted

October 28, 2019

Study Start

February 25, 2020

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations