MalesPhase 3NCT01406730
Running Effect on Cardiovascular and Muscular Parameters
A Phase 3 study testing exercise in people with Males and Untrained, run by University of Erlangen-Nürnberg Medical School at 3 sites in Germany.
Trial summary
The purpose of the study is to determine the effect of 16 weeks of running exercise on various parameters related to heart, vascular systems, blood, and muscle in untrained males 30-50 years old. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Males, Untrained, 30-50 Years Old
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesGermany
- Study dates
- Jul 2011to Jul 2012
- Phase
- Phase 3
- 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 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- males
- untrained (< 2 endurance exercise sessions/week)
- 30-50 years old
Who cannot join
- pathological changes of the heart
- inflammable diseases
- medication/diseases affecting cardiovascular system and muscle
- very low physical capacity (< 100 Watt at ergometry)
- obesity (BMI > 30 kg/m2)
- more than 2 weeks of absence during the interventional period
- more than 2 exercise session beside the intervention
- contraindication related to MRI-assessment (i.e. claustrophobia, magnetizable intracorporal artefacts)
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Institute of Medical Physics, University of Erlangen-Nurnberg
Erlangen, 91052
Institute of Physical Education and Sport Sciences
Erlangen, 91052
Departement of Radiology, University of Erlangen-Nurnberg
Erlangen, 91054
About this study
Official title: Effect of 16 Weeks of Running Exercise on Parameters Related to the Cardiovascular System, Blood and Muscle in Untrained Males 30-50 Years Old. A Randomized Controlled Study
The purpose of the study is to determine the effect of 16 weeks of running exercise on various parameters related to heart, vascular systems, blood, and muscle in untrained males 30-50 years old.
Further, the investigators assess which of the above mentioned parameters may explain the increase of running performance most accurate.
- Conditions
- Males, Untrained, 30-50 Years Old, Healthy
- Being tested
- exercise
- Keywords
- running exercise, cardiac hypertrophy, blood, maximum oxygen uptake, intervention, untrained, males
- Medical subject headings
- Cardiomegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
16 week of periodized progressive running exercise 2-4 times/week
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | 16 weeks of running exercise Receives: Other: exercise |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial mass/stroke volume
Atrial and ventricular volume and mass indexes were assessed by magnetic resonance imaging (MRI)
Measured: 4 month
Secondary outcomes (5)
maximal oxygen uptake
maximal oxygen uptake during running
Measured: 4 month
Resting metabolic rate
Adaptation of resting metabolic rate to running exercise
Measured: 4 month
muscle strength/power
Isometric muscle strength of the leg extensors Leg power as assessed by counter movement jump
Measured: 4 month
myocardial volume
Functional and morphologic parameters of the heart as assessed by echocardiography
Measured: 4 month
Intima media thickness
Carotid intima media thickness by high-resolution ultrasound
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University of Erlangen-Nürnberg, Institute of Physical Education and Sports Sciences, Klinikum Nürnberg
- Responsible party
- Principal investigator, Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
- Investigators
- Michael Lell, MD, Study director, Departement of Radiology, Division of Cardiology, University of Erlangen-NurnbergMichael Scharf, MD, Principal investigator, Departement of Radiology, Division of CardiologyWilli A Kalender, PhD, Study chair, Institute of Medical Physics, University of Erlangen, GermanyMichael Uder, MD, Study chair, Departement of Radiology, University of Erlangen-NurnbergWolfgang Kemmler, PhD, Study director, Institute of Medical Physics, University of Erlangen-Nurnberg, GermanySimon von Stengel, PhD, Principal investigator, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406730
- Sponsor's protocol ID
- FAU-IMP-4463
- Status last verified
- Aug 2012
- First submitted
- 18 Jul 2011
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scharf M, Brem MH, Wilhelm M, Schoepf UJ, Uder M, Lell MM. Atrial and ventricular functional and structural adaptations of the heart in elite triathletes assessed with cardiac MR imaging. Radiology. 2010 Oct;257(1):71-9. doi: 10.1148/radiol.10092377. Epub 2010 Aug 31.
PubMed 20807850Tuttor M, von Stengel S, Kohl M, Lell M, Scharf M, Uder M, Wittke A, Kemmler W. High Intensity Resistance Exercise Training vs. High Intensity (Endurance) Interval Training to Fight Cardiometabolic Risk Factors in Overweight Men 30-50 Years Old. Front Sports Act Living. 2020 Jun 16;2:68. doi: 10.3389/fspor.2020.00068. eCollection 2020.
PubMed 33345059Scharf M, Schmid A, Kemmler W, von Stengel S, May MS, Wuest W, Achenbach S, Uder M, Lell MM. Myocardial adaptation to high-intensity (interval) training in previously untrained men with a longitudinal cardiovascular magnetic resonance imaging study (Running Study and Heart Trial). Circ Cardiovasc Imaging. 2015 Apr;8(4):e002566. doi: 10.1161/CIRCIMAGING.114.002566.
PubMed 25873721
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 16 Weeks of Running Exercise on Parameters Related to the Cardiovascular System, Blood and Muscle in Untrained Males 30-50 Years Old. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01406730
- Acronym / sponsor ID
- FAU-IMP-4463
- Conditions
- Males, Untrained, 30-50 Years Old, Healthy
- Keywords
- running exercise, cardiac hypertrophy, blood, maximum oxygen uptake, intervention, untrained, males
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- University of Erlangen-Nürnberg, Institute of Physical Education and Sports Sciences, Klinikum Nürnberg
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Aug 2011 (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.
The purpose of the study is to determine the effect of 16 weeks of running exercise on various parameters related to heart, vascular systems, blood, and muscle in untrained males 30-50 years old.
Further, the investigators assess which of the above mentioned parameters may explain the increase of running performance most accurate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Other: exercise16 weeks of running exercise |
| control | No intervention | – |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- males
- untrained (< 2 endurance exercise sessions/week)
- 30-50 years old
Key exclusion criteria (8 listed)
- pathological changes of the heart
- inflammable diseases
- medication/diseases affecting cardiovascular system and muscle
- very low physical capacity (< 100 Watt at ergometry)
- obesity (BMI > 30 kg/m2)
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 |
|---|---|---|
| exercise16 week of periodized progressive running exercise 2-4 times/week | Other | exercise |
Primary outcome
myocardial mass/stroke volume
Time frame: 4 month
Atrial and ventricular volume and mass indexes were assessed by magnetic resonance imaging (MRI)
5 secondary outcomes
maximal oxygen uptake
Time frame: 4 month
Resting metabolic rate
Time frame: 4 month
muscle strength/power
Time frame: 4 month
myocardial volume
Time frame: 4 month
Intima media thickness
Time frame: 4 month
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 14 Aug 2012.
- Background: PubMed 20807850Scharf M, Brem MH, Wilhelm M, Schoepf UJ, Uder M, Lell MM. Atrial and ventricular functional and structural adaptations of the heart in elite triathletes assessed with cardiac MR imaging. Radiology. 2010 Oct;257(1):71-9. doi: 10.1148/radiol.10092377. Epub 2010 Aug 31.
- Derived from this study: PubMed 33345059Tuttor M, von Stengel S, Kohl M, Lell M, Scharf M, Uder M, Wittke A, Kemmler W. High Intensity Resistance Exercise Training vs. High Intensity (Endurance) Interval Training to Fight Cardiometabolic Risk Factors in Overweight Men 30-50 Years Old. Front Sports Act Living. 2020 Jun 16;2:68. doi: 10.3389/fspor.2020.00068. eCollection 2020.
- Derived from this study: PubMed 25873721Scharf M, Schmid A, Kemmler W, von Stengel S, May MS, Wuest W, Achenbach S, Uder M, Lell MM. Myocardial adaptation to high-intensity (interval) training in previously untrained men with a longitudinal cardiovascular magnetic resonance imaging study (Running Study and Heart Trial). Circ Cardiovasc Imaging. 2015 Apr;8(4):e002566. doi: 10.1161/CIRCIMAGING.114.002566.
- homepage of the Institute of Medical Physical with study informations.Link provided by the sponsor.
Related trials for Males
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingObservational study
Study of Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia
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.
Michael Lell, MD study director
Departement of Radiology, Division of Cardiology, University of Erlangen-Nurnberg
Michael Scharf, MD principal investigator
Departement of Radiology, Division of Cardiology
Willi A Kalender, PhD study chair
Institute of Medical Physics, University of Erlangen, Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing exercise in people with Males and Untrained, run by University of Erlangen-Nürnberg Medical School at 3 sites in Germany.
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 8 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 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
myocardial mass/stroke volume (time frame: 4 month). 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 NCT01406730, which also lists 3 linked publications.
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 14 Aug 2012.