SarcopeniaPhase 3NCT01766791
Resistance Exercise, Muscle Mass, Strength and Body Composition
A Phase 3 study testing HIT-exercise, low repetition range, HIT-exercise, high repetition range and HIT-exercise with protein in people with Sarcopenia and Obesity, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
A plethora of trials reported the positive effect of resistance exercise on functional and morphological parameters. Although a large amount of the studies used suboptimum devices and obsolete methods the results of these older studies were still considered as golden standard. 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
- Sarcopenia, Obesity
- What is being tested?
- HIT-exercise, low repetition range, HIT-exercise, high repetition range and HIT-exercise with protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Mar 2014
- 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 h exercise/week, < 1 h resistance exercise/week)
- 30-50 years old
Who cannot join
- medication/diseases affecting intervention or study endpoints
- history of intense resistance exercise (> 3 h/week during the last decade)
- very low physical capacity (< 100 Watt at ergometry)
- more than 2 weeks of absence during the interventional period
- contraindication related to MRI-assessment (i.e. magnetizable intracorporal artefacts)
- pathological changes of the heart
- inflammable diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics, University of Erlangen-Nurnberg
Erlangen, 91052
About this study
Official title: Effects of Resistance Exercise on Muscle Mass, Strength, Body Composition and Heart in Men 30-50 Years Old.
A plethora of trials reported the positive effect of resistance exercise on functional and morphological parameters. Although a large amount of the studies used suboptimum devices and obsolete methods the results of these older studies were still considered as golden standard. The aim of the present study is thus to determine the proper effect of different resistance exercise protocols with and without adjuvant protein supplementation on functional and morphological muscle and body composition parameters in male untrained subjects 30-50 years old under special regard of modern medical imaging and segmentation technologies.
Our general study hypothesis is that HIT-resistance exercise significantly impact relevant muscular parameters of the upper leg.
- Conditions
- Sarcopenia, Obesity
- Being tested
- HIT-exercise, low repetition range, HIT-exercise, high repetition range, HIT-exercise with protein, Control
- Keywords
- resistance exercise, muscle mass, abdominal fat, strength, Coronary Heart Disease (CHD)-risk, myocardial mass
- Medical subject headings
- Sarcopenia, Obesity, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIT-exercise, low repetition rangeOther
High Intensity Resistance Exercise Training, low repetition range, > 75% 1RM
HIT-exercise, high repetition rangeOther
High Intensity Resistance Exercise Training, high repetition range, 60 - < 75 1RM
HIT-exercise with proteinOther
High Intensity Resistance Exercise Training, low repetition range, > 75% 1RM and Protein Supplementation
ControlOther
control group, no intervention, maintenance of physical activity
| Study group | Role | What they receive |
|---|---|---|
| HIT-exercise, low repetition range | Experimental | High Intensity Resistance Exercise Training, low repetition range, > 75% 1 Repetition Maximum (1RM) Receives: Other: HIT-exercise, low repetition range |
| HIT-exercise, high repetition range | Experimental | High Intensity Resistance Exercise Training, high repetition range, 60 - <75% 1RM Receives: Other: HIT-exercise, high repetition range |
| HIT-exercise with protein | Experimental | High Intensity Resistance Exercise Training with protein supplementation Receives: Other: HIT-exercise with protein |
| Control | Placebo comparator | No physical exercise intervention Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
fat free Cross Sectional Area (CSA) upper leg
fat free muscle cross sectional area of the upper leg at mid-femur via Quantitative Computed Tomography (QCT)
Measured: change from baseline in fat free Cross Sectional Area at 5 months
Secondary outcomes (1)
CSA upper leg
muscle cross sectional area of the upper leg at mid-femur via QCT
Measured: change from baseline in CSA upper leg at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Nürnberg
- Responsible party
- Sponsor
- Investigators
- Wolfgang Kemmler, PhD, Study director, University of Erlangen-Nürnberg Medical SchoolAndreas Wittke, MA, Principal investigator, University of Erlangen-Nürnberg Medical SchoolKlaus Engelke, PhD, Study chair, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766791
- Sponsor's protocol ID
- PUSH-D-ER
- Other IDs
- Study-098
- Status last verified
- Mar 2014
- First submitted
- 7 Jan 2013
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tuttor 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, Oezdemir D, Schmid A, Kemmler W, von Stengel S, May MS, Uder M, Lell MM. Myocardial adaption to HI(R)T in previously untrained men with a randomized, longitudinal cardiac MR imaging study (Physical adaptions in Untrained on Strength and Heart trial, PUSH-trial). PLoS One. 2017 Dec 7;12(12):e0189204. doi: 10.1371/journal.pone.0189204. eCollection 2017.
PubMed 29216285
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Exercise on Muscle Mass, Strength, Body Composition and Heart in Men 30-50 Years Old.
- ClinicalTrials.gov ID
- NCT01766791
- Acronym / sponsor ID
- PUSH-D-ER
- Conditions
- Sarcopenia, Obesity
- Keywords
- resistance exercise, muscle mass, abdominal fat, strength, Coronary Heart Disease (CHD)-risk, myocardial mass
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Klinikum Nürnberg
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Jan 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.
A plethora of trials reported the positive effect of resistance exercise on functional and morphological parameters. Although a large amount of the studies used suboptimum devices and obsolete methods the results of these older studies were still considered as golden standard. The aim of the present study is thus to determine the proper effect of different resistance exercise protocols with and without adjuvant protein supplementation on functional and morphological muscle and body composition parameters in male untrained subjects 30-50 years old under special regard of modern medical imaging and segmentation technologies.
Our general study hypothesis is that HIT-resistance exercise significantly impact relevant muscular parameters of the upper leg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIT-exercise, low repetition range | Experimental | Other: HIT-exercise, low repetition rangeHigh Intensity Resistance Exercise Training, low repetition range, > 75% 1 Repetition Maximum (1RM) |
| HIT-exercise, high repetition range | Experimental | Other: HIT-exercise, high repetition rangeHigh Intensity Resistance Exercise Training, high repetition range, 60 - <75% 1RM |
| HIT-exercise with protein | Experimental | Other: HIT-exercise with proteinHigh Intensity Resistance Exercise Training with protein supplementation |
| Control | Placebo comparator | Other: ControlNo physical exercise 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 h exercise/week, < 1 h resistance exercise/week)
- 30-50 years old
Key exclusion criteria (7 listed)
- medication/diseases affecting intervention or study endpoints
- history of intense resistance exercise (> 3 h/week during the last decade)
- very low physical capacity (< 100 Watt at ergometry)
- more than 2 weeks of absence during the interventional period
- contraindication related to MRI-assessment (i.e. magnetizable intracorporal artefacts)
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 |
|---|---|---|
| HIT-exercise, low repetition rangeHigh Intensity Resistance Exercise Training, low repetition range, > 75% 1RM | Other | HIT-exercise, low repetition range |
| HIT-exercise, high repetition rangeHigh Intensity Resistance Exercise Training, high repetition range, 60 - < 75 1RM | Other | HIT-exercise, high repetition range |
| HIT-exercise with proteinHigh Intensity Resistance Exercise Training, low repetition range, > 75% 1RM and Protein Supplementation | Other | HIT-exercise with protein |
| Controlcontrol group, no intervention, maintenance of physical activity | Other | Control |
Primary outcome
fat free Cross Sectional Area (CSA) upper leg
Time frame: change from baseline in fat free Cross Sectional Area at 5 months
fat free muscle cross sectional area of the upper leg at mid-femur via Quantitative Computed Tomography (QCT)
1 secondary outcome
CSA upper leg
Time frame: change from baseline in CSA upper leg at 5 months
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 21 Mar 2014.
- 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 29216285Scharf M, Oezdemir D, Schmid A, Kemmler W, von Stengel S, May MS, Uder M, Lell MM. Myocardial adaption to HI(R)T in previously untrained men with a randomized, longitudinal cardiac MR imaging study (Physical adaptions in Untrained on Strength and Heart trial, PUSH-trial). PLoS One. 2017 Dec 7;12(12):e0189204. doi: 10.1371/journal.pone.0189204. eCollection 2017.
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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.
Wolfgang Kemmler, PhD study director
University of Erlangen-Nürnberg Medical School
Andreas Wittke, MA principal investigator
University of Erlangen-Nürnberg Medical School
Klaus Engelke, PhD study chair
University of Erlangen-Nürnberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HIT-exercise, low repetition range, HIT-exercise, high repetition range and HIT-exercise with protein in people with Sarcopenia and Obesity, run by University of Erlangen-Nürnberg Medical School at 1 site 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 7 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 21 Mar 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 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. Some participants in this study may receive a placebo. 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?
fat free Cross Sectional Area (CSA) upper leg (time frame: change from baseline in fat free Cross Sectional Area at 5 months). 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 NCT01766791, which also lists 2 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 21 Mar 2014.