Substance Use DisordersNCT04065334
Exercise Training as Medicine for Substance Use Disorder Patients
A study testing High dose training and low dose training in people with Substance Use Disorders, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
This study compares the effects of high dose and low dose, high intensity, endurance training and strength training in substance use disorder patients. The hypothesis is that the increase in endurance (measured as maximal oxygen uptake) and strength (measured as maximal strength) will be similar in both the high dose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- High dose training and low dose training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2020to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Being an inpatient at the clinic
- Free of known cardiovascular disease, pulmonary disease and cancer
Who cannot join
- Not able to perform a maximal treadmill test
- Not able to perform a maximal strength test in hack squat
Trial locations and contacts
1 site in 1 country.
Norway1 site
Klinikk for rus- og avhengighetsmedisin, St Olavs Hospital
Trondheim
About this study
Official title: Effects of Low- Versus High Dose High Intensity Interval Training and Strength Training on Physical Health in Substance Use Disorder Patients: A Randomized Controlled Trial
This study compares the effects of high dose and low dose, high intensity, endurance training and strength training in substance use disorder patients. The hypothesis is that the increase in endurance (measured as maximal oxygen uptake) and strength (measured as maximal strength) will be similar in both the high dose and low dose training groups after 24 training sessions over eight weeks. The rationale for this assumption is based on the patient groups poor physical capacity, supporting that a lesser physical workload is needed to achieve a substantial increase in physical capacity. The practical implication could be higher training attendance, because it is likely easier to motivate the patient group when they only have to perform half the workload. It is paramount for this patient group to increase their physical capacity and consequently augment their physical health status since they are in a high-risk group for developing life-threatening lifestyle related diseases.
- Conditions
- Substance Use Disorders
- Being tested
- High dose training, low dose training
- Keywords
- Resistance training, Endurance training
- 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.
High dose trainingBehavioural
4 x 4 minutes of high intensity workload on treadmill and 4 repetitions x 4 sets of high intensity workload in hack squat
low dose trainingBehavioural
1 x 4 minutes of high intensity workload on treadmill and 2 repetitions x 4 sets of high intensity workload in hack squat
| Study group | Role | What they receive |
|---|---|---|
| low dose training | Experimental | Not described Receives: Behavioral: low dose training |
| high dose training | Active comparator | Not described Receives: Behavioral: High dose training |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in oxygen uptake
cardiopulmonary exercise test (CPET) objective gas measurements
Measured: baseline to 8 weeks
change in leg muscular strength
One repetition maximum strength test half squat
Measured: baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Feb 2020
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Kristin Smedsrud, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065334
- Sponsor's protocol ID
- 2019/502
- Status last verified
- Jun 2025
- First submitted
- 21 Aug 2019
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loe H, Mosti MP, Wisloff U, Haberstroh C, Flemmen G. Cardiopulmonary and muscular effects of different doses of high-intensity physical training in substance use disorder patients: study protocol for a block allocated controlled endurance and strength training trial in an inpatient setting. BMJ Open. 2022 Sep 27;12(9):e061014. doi: 10.1136/bmjopen-2022-061014.
PubMed 36167363
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low- Versus High Dose High Intensity Interval Training and Strength Training on Physical Health in Substance Use Disorder Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04065334
- Acronym / sponsor ID
- 2019/502
- Conditions
- Substance Use Disorders
- Keywords
- Resistance training, Endurance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 22 Aug 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.
This study compares the effects of high dose and low dose, high intensity, endurance training and strength training in substance use disorder patients. The hypothesis is that the increase in endurance (measured as maximal oxygen uptake) and strength (measured as maximal strength) will be similar in both the high dose and low dose training groups after 24 training sessions over eight weeks. The rationale for this assumption is based on the patient groups poor physical capacity, supporting that a lesser physical workload is needed to achieve a substantial increase in physical capacity. The practical implication could be higher training attendance, because it is likely easier to motivate the patient group when they only have to perform half the workload. It is paramount for this patient group to increase their physical capacity and consequently augment their physical health status since they are in a high-risk group for developing life-threatening lifestyle related diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose training | Experimental | Behavioral: low dose training |
| high dose training | Active comparator | Behavioral: High dose training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being an inpatient at the clinic
- Free of known cardiovascular disease, pulmonary disease and cancer
Key exclusion criteria (2 listed)
- Not able to perform a maximal treadmill test
- Not able to perform a maximal strength test in hack squat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose training4 x 4 minutes of high intensity workload on treadmill and 4 repetitions x 4 sets of high intensity workload in hack squat | Behavioural | high dose training |
| low dose training1 x 4 minutes of high intensity workload on treadmill and 2 repetitions x 4 sets of high intensity workload in hack squat | Behavioural | low dose training |
Primary outcome
change in oxygen uptake
Time frame: baseline to 8 weeks
cardiopulmonary exercise test (CPET) objective gas measurements
change in leg muscular strength
Time frame: baseline to 8 weeks
One repetition maximum strength test half squat
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Derived from this study: PubMed 36167363Loe H, Mosti MP, Wisloff U, Haberstroh C, Flemmen G. Cardiopulmonary and muscular effects of different doses of high-intensity physical training in substance use disorder patients: study protocol for a block allocated controlled endurance and strength training trial in an inpatient setting. BMJ Open. 2022 Sep 27;12(9):e061014. doi: 10.1136/bmjopen-2022-061014.
- Individual participant dataSharing planned: No
Related trials for Substance Use Disorders
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
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder
Recruiting
Coordinated Care for Alcohol Problems
Alcohol Use Disorder
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
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. This study is not recruiting at the moment.
Kristin Smedsrud study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose training and low dose training in people with Substance Use Disorders, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in oxygen uptake (time frame: baseline to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04065334, which also lists 1 linked publication.
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 8 Jun 2025.