Heart FailureNCT00184457
Maximal Leg Press Strength Training Study for Coronary Artery Disease Patients
A study testing Strength training intervention in people with Heart Failure and Coronary Artery Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Maximal strength training has been shown to increase muscular strength, muscular volume and work economy. An 8 week maximal leg press training regime will be conducted on cardiac heart failure patients to evaluate whether they increase their maximal leg press strength, work economy, serum testosterone and quality of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure, Coronary Artery Disease
- What is being tested?
- Strength training intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2005to Sep 2007
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed coronary artery disease
- Stable coronary artery disease
- 1.5 mm depression in ST segment during a cycling strain test
- Between 18-70 years of age
Who cannot join
- Unstable coronary artery disease
- Other limitations to exercise than coronary artery disease
- Participants in other study interventions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maximal Leg Press Strength Training for Coronary Artery Disease Patients. Training Effect on Serum Testosterone and Work Economy
Maximal strength training has been shown to increase muscular strength, muscular volume and work economy. An 8 week maximal leg press training regime will be conducted on cardiac heart failure patients to evaluate whether they increase their maximal leg press strength, work economy, serum testosterone and quality of life. The study hypotheses are that:
- Aerobic work capacity will increase due to increased work economy, without increases in maximal oxygen uptake.
- Strength training will increase serum testosterone.
- Conditions
- Heart Failure, Coronary Artery Disease
- Being tested
- Strength training intervention
- Keywords
- Cardiac heart failure, Leg press, Maximal strength training, Serum testosterone, Work economy
- Medical subject headings
- Heart Failure, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal leg press strength
Work economy
Serum testosterone
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionApr 2007
- Study completionSep 2007
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 Heart FailureStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- Asbjørn Støylen, MD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184457
- Sponsor's protocol ID
- 25060100
- Status last verified
- Nov 2011
- First submitted
- 15 Sep 2005
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Karlsen T, Helgerud J, Stoylen A, Lauritsen N, Hoff J. Maximal strength training restores walking mechanical efficiency in heart patients. Int J Sports Med. 2009 May;30(5):337-42. doi: 10.1055/s-0028-1105946. Epub 2009 Feb 6.
PubMed 19199203
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Leg Press Strength Training for Coronary Artery Disease Patients. Training Effect on Serum Testosterone and Work Economy
- ClinicalTrials.gov ID
- NCT00184457
- Acronym / sponsor ID
- 25060100
- Conditions
- Heart Failure, Coronary Artery Disease
- Keywords
- Cardiac heart failure, Leg press, Maximal strength training, Serum testosterone, Work economy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 16 Sep 2005 (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.
Maximal strength training has been shown to increase muscular strength, muscular volume and work economy. An 8 week maximal leg press training regime will be conducted on cardiac heart failure patients to evaluate whether they increase their maximal leg press strength, work economy, serum testosterone and quality of life. The study hypotheses are that:
- Aerobic work capacity will increase due to increased work economy, without increases in maximal oxygen uptake.
- Strength training will increase serum testosterone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically diagnosed coronary artery disease
- Stable coronary artery disease
- 1.5 mm depression in ST segment during a cycling strain test
- Between 18-70 years of age
Key exclusion criteria (3 listed)
- Unstable coronary artery disease
- Other limitations to exercise than coronary artery disease
- Participants in other study interventions
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 intervention | Behavioural | – |
Primary outcome
Maximal leg press strength
Work economy
Serum testosterone
Quality of life
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 18 Jan 2017.
- Results publication: PubMed 19199203Karlsen T, Helgerud J, Stoylen A, Lauritsen N, Hoff J. Maximal strength training restores walking mechanical efficiency in heart patients. Int J Sports Med. 2009 May;30(5):337-42. doi: 10.1055/s-0028-1105946. Epub 2009 Feb 6.
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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.
Asbjørn Støylen, MD 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 Strength training intervention in people with Heart Failure and Coronary Artery Disease, 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 4 inclusion and 3 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 18 Jan 2017. 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?
Maximal leg press strength. The study lists 4 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 NCT00184457, 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 18 Jan 2017.