Substance-Related DisordersNCT04141202
Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder
An observational study of Substance-Related Disorders and Drug Abuse, run by St. Olavs Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-Related Disorders, Drug Abuse, Drug Dependence
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 25 Feb 2020to 30 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed with substance use disorder.
Who may be able to join
- Being an inpatient at the clinic
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Henrik Loe, phd contact
Norway1 site, 1 recruiting
- Recruiting
St Olavs Hospital HF Klinikk for rus og avhengighetsmedisin
Trondheim, 7010
Grete Flemmen, phd, +47 908 77 876, grete.flemmen@stolav.no
About this study
Official title: Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder: Implications for Abstinence, Quality of Life, Physical- and Mental Health
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.
- Conditions
- Substance-Related Disorders, Drug Abuse, Drug Dependence
- Keywords
- Exercise therapy, Exercise physiology
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical health
Change in oxygen uptake
Measured: 18 months
Physical health
Change in maximum leg strength
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start25 Feb 2020
- Primary completion30 Dec 2035 (estimated)
- Study completion30 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Smedsrud, Study director, St Olavs Hospital Klinikk for rus- og avhengighetsmedisin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141202
- Sponsor's protocol ID
- 2019/501
- Status last verified
- Jul 2026
- First submitted
- 24 Oct 2019
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder: Implications for Abstinence, Quality of Life, Physical- and Mental Health
- ClinicalTrials.gov ID
- NCT04141202
- Acronym / sponsor ID
- 2019/501
- Conditions
- Substance-Related Disorders, Drug Abuse, Drug Dependence
- Keywords
- Exercise therapy, Exercise physiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 30 Dec 2035 (estimated)
- Study completion
- 30 Dec 2035 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with substance use disorder.
Key inclusion criteria (1 listed)
- Being an inpatient at the clinic
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical health
Time frame: 18 months
Change in oxygen uptake
Physical health
Time frame: 18 months
Change in maximum leg strength
Mental health
Time frame: 18 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Substance-Related Disorders
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henrik Loe, phd contact
Kristin Smedsrud study director
St Olavs Hospital Klinikk for rus- og avhengighetsmedisin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance-Related Disorders and Drug Abuse, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grete Flemmen, phd (+47 908 77 876, grete.flemmen@stolav.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical health (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.