Substance-Related DisordersNCT02017821
The Effect of Aerobic Endurance Training in Patients With Drug Addiction
A study testing high intensity aerobic training in people with Substance-Related Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Physical health does not have a high priority in today's treatment of patients with substance use disorder (SUD) patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the lifestyle that addiction causes. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- high intensity aerobic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2012to Jan 2014
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- substance use disorder diagnosed ICD10
- written informed consent
- "residential treatment"
Who cannot join
- not been using drugs the last six months
Trial locations and contacts
1 site in 1 country.
About this study
Physical health does not have a high priority in today's treatment of patients with substance use disorder (SUD) patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the lifestyle that addiction causes. There are today few studies that provide information about SUD patients' physical health. One of the project's aims is to document the physical health of SUD patients in treatment, using objective measures. After completion of various physical tests, an 8 week period of high intensity aerobic training intervention will follow. It will be investigated if the SUD patients are able to engage and participate throughout the whole training intervention, to what degree the participants improve their physical health and the effect of physical health improvement on substance abuse treatment.
- Conditions
- Substance-Related Disorders
- Being tested
- high intensity aerobic training
- Keywords
- Exercise, Oxygen Consumption, mental health
- Medical subject headings
- Substance-Related Disorders, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity aerobic trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| training group | Experimental | high intensity aerobic training 3 weekly sessions for 8 weeks Receives: Behavioral: high intensity aerobic training |
| care as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in maximal oxygen consumption (VO2 max)
Directly measurement of maximal oxygen consumption. Measurement of work efficiency and lactate measurements. Insomnia Severity Index and Hospital Anxiety and Depression scale is used to measure mental health.
Measured: from 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 posted23 Dec 2013 (estimated)
- Study startAug 2012
- Primary completionNov 2013
- Study completionJan 2014
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-Related DisordersStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Eivind Wang, phd, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017821
- Sponsor's protocol ID
- 2012/639
- Status last verified
- Aug 2014
- First submitted
- 17 Dec 2013
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Flemmen G, Unhjem R, Wang E. High-intensity interval training in patients with substance use disorder. Biomed Res Int. 2014;2014:616935. doi: 10.1155/2014/616935. Epub 2014 Mar 2.
PubMed 24724089
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Endurance Training in Patients With Drug Addiction
- ClinicalTrials.gov ID
- NCT02017821
- Acronym / sponsor ID
- 2012/639
- Conditions
- Substance-Related Disorders
- Keywords
- Exercise, Oxygen Consumption, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Aug 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Dec 2013 (estimated)
- 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.
Physical health does not have a high priority in today's treatment of patients with substance use disorder (SUD) patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the lifestyle that addiction causes. There are today few studies that provide information about SUD patients' physical health. One of the project's aims is to document the physical health of SUD patients in treatment, using objective measures. After completion of various physical tests, an 8 week period of high intensity aerobic training intervention will follow. It will be investigated if the SUD patients are able to engage and participate throughout the whole training intervention, to what degree the participants improve their physical health and the effect of physical health improvement on substance abuse treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training group | Experimental | Behavioral: high intensity aerobic traininghigh intensity aerobic training 3 weekly sessions for 8 weeks |
| care as usual | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- substance use disorder diagnosed ICD10
- written informed consent
- "residential treatment"
Key exclusion criteria (1 listed)
- not been using drugs the last six months
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 intensity aerobic training | Behavioural | training group |
Primary outcome
change in maximal oxygen consumption (VO2 max)
Time frame: from baseline to 8 weeks
Directly measurement of maximal oxygen consumption. Measurement of work efficiency and lactate measurements. Insomnia Severity Index and Hospital Anxiety and Depression scale is used to measure mental health.
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 13 Aug 2014.
- Results publication: PubMed 24724089Flemmen G, Unhjem R, Wang E. High-intensity interval training in patients with substance use disorder. Biomed Res Int. 2014;2014:616935. doi: 10.1155/2014/616935. Epub 2014 Mar 2.
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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.
Eivind Wang, phd study director
Norwegian University of Science and Technology
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 intensity aerobic training in people with Substance-Related Disorders, run by Norwegian University of Science and Technology 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 3 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: finished, as of the sponsor's last update on 13 Aug 2014. 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 maximal oxygen consumption (VO2 max) (time frame: from baseline to 8 weeks). 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 NCT02017821, 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 13 Aug 2014.