Clinical trial NCT01766791: Resistance Exercise, Muscle Mass, Strength and Body Composition
Official title: Effects of Resistance Exercise on Muscle Mass, Strength, Body Composition and Heart in Men 30-50 Years Old.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sarcopenia
Obesity
Keywords: resistance exercise
muscle mass
abdominal fat
strength
Coronary Heart Disease (CHD)-risk
myocardial mass
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Klinikum Nürnberg
First posted: 2013-01-11
Enrollment: 120
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* males
* untrained (\< 2 h exercise/week, \< 1 h resistance exercise/week)
* 30-50 years old

Exclusion Criteria:

* 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

Primary outcomes:
measure: fat free Cross Sectional Area (CSA) upper leg
timeFrame: change from baseline in fat free Cross Sectional Area at 5 months
Secondary outcomes:
measure: CSA upper leg
timeFrame: change from baseline in CSA upper leg at 5 months
Other outcomes:
measure: intra-abdominal fat mass
timeFrame: change from baseline in intra-abdominal fat mass at 5 months
measure: maximum strength leg press
timeFrame: change from baseline in maximum strength leg press at 5 months
measure: metabolic syndrome score
timeFrame: change from baseline in metabolic syndrome score at 5 months
measure: myocardial mass/enddiastolic volume
timeFrame: change from baseline in myocardial mass/enddiastolic volume at 5 months
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, University of Erlangen-Nurnberg
Study officials:
affiliation: University of Erlangen-Nürnberg Medical School
name: Wolfgang Kemmler, PhD
role: STUDY_DIRECTOR
affiliation: University of Erlangen-Nürnberg Medical School
name: Andreas Wittke, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Erlangen-Nürnberg Medical School
name: Klaus Engelke, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Scharf 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.