Substance-related DisordersNCT02218970
The Effect of Muscular Strength Training in Patients With Drug Addiction
A study testing strength 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). SUD patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the addiction-related lifestyle. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Substance-related Disorders
- What is being tested?
- strength 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
- Sep 2012to Jan 2015
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- being treated for drug abuse
- not using drugs during intervention period
Who cannot join
- participated in strength training in previous 6 months
- cardiovascular disease
- any other disease that impedes to finish tests
- not showing up for testing sessions
- carried out less than 85% of planned exercise sessions
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). SUD patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the addiction-related lifestyle. There are few studies today that provide information about SUD patient's physical health, and especially there is little information about their muscular strength. One of the project's aims is to measure muscular strength in SUD patients who are being treated for their addiction, and see if they have decreased neuromuscular function. If so, we will investigate the effect of maximal strength training on neuromuscular function in these patients.
- Conditions
- Substance-related Disorders
- Being tested
- strength training, no training (control)
- Keywords
- rehabilitation, strength training, muscle strength, physical fitness
- 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.
strength trainingBehavioural
no training (control)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| strength training | Experimental | Strength training for leg muscles during10 weeks, 3 times a week: hack squat and plantar flexion, standing upright in a hack squat machine and lying down in a calf rise machine. Exercises will be carried out at 85% of 1-RM intensity under supervision at the institution where participants are having their SUD treatment. Receives: Behavioral: strength training |
| control | Other | patients treated for substance-related disorder but not participating in strength training intervention (no training control group) Receives: Behavioral: no training (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
Assessed peripheral muscle strength by one repetition maximum test (1RM)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionJan 2015
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
- Responsible party
- Sponsor
- Investigators
- Grete Flemmen, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218970
- Sponsor's protocol ID
- 2012/640
- Status last verified
- May 2020
- First submitted
- 14 Aug 2014
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Unhjem R, Flemmen G, Hoff J, Wang E. Maximal strength training as physical rehabilitation for patients with substance use disorder; a randomized controlled trial. BMC Sports Sci Med Rehabil. 2016 Mar 31;8:7. doi: 10.1186/s13102-016-0032-2. eCollection 2016.
PubMed 27042312
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Muscular Strength Training in Patients With Drug Addiction
- ClinicalTrials.gov ID
- NCT02218970
- Acronym / sponsor ID
- 2012/640
- Conditions
- Substance-related Disorders
- Keywords
- rehabilitation, strength training, muscle strength, physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Aug 2014 (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). SUD patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the addiction-related lifestyle. There are few studies today that provide information about SUD patient's physical health, and especially there is little information about their muscular strength. One of the project's aims is to measure muscular strength in SUD patients who are being treated for their addiction, and see if they have decreased neuromuscular function. If so, we will investigate the effect of maximal strength training on neuromuscular function in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| strength training | Experimental | Behavioral: strength trainingStrength training for leg muscles during10 weeks, 3 times a week: hack squat and plantar flexion, standing upright in a hack squat machine and lying down in a calf rise machine. Exercises will be carried out at 85% of 1-RM intensity under supervision at the institution where participants are having their SUD treatment. |
| control | Other | Behavioral: no training (control)patients treated for substance-related disorder but not participating in strength training intervention (no training control group) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- being treated for drug abuse
- not using drugs during intervention period
Key exclusion criteria (5 listed)
- participated in strength training in previous 6 months
- cardiovascular disease
- any other disease that impedes to finish tests
- not showing up for testing sessions
- carried out less than 85% of planned exercise sessions
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 |
|---|---|---|
| strength training | Behavioural | strength training |
| no training (control) | Behavioural | control |
Primary outcome
muscle strength
Time frame: 10 weeks
Assessed peripheral muscle strength by one repetition maximum test (1RM)
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 May 2020.
- Results publication: PubMed 27042312Unhjem R, Flemmen G, Hoff J, Wang E. Maximal strength training as physical rehabilitation for patients with substance use disorder; a randomized controlled trial. BMC Sports Sci Med Rehabil. 2016 Mar 31;8:7. doi: 10.1186/s13102-016-0032-2. eCollection 2016.
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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.
Grete Flemmen principal investigator
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 strength 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 2 inclusion and 5 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 May 2020. 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?
muscle strength (time frame: 10 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 NCT02218970, 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 May 2020.