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CompletedNCT01766791Updated Mar 21, 2014

Resistance Exercise, Muscle Mass, Strength and Body Composition

A Phase 3 interventional study of HIT-exercise, low repetition range and HIT-exercise, high repetition range in Sarcopenia and Obesity, sponsored by University of Erlangen-Nürnberg Medical School. Completed at 1 site in Germany. Open to male participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-21.

Sponsored by University of Erlangen-Nürnberg Medical School · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
Male
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Study 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.

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Conditions studied

  • Sarcopenia
  • Obesity

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Keywords

  • resistance exercise
  • muscle mass
  • abdominal fat
  • strength
  • Coronary Heart Disease (CHD)-risk
  • myocardial mass
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In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 120 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    HIT-exercise, low repetition range

    High Intensity Resistance Exercise Training, low repetition range, \> 75% 1 Repetition Maximum (1RM)

    Other: HIT-exercise, low repetition range

  • Experimental
    HIT-exercise, high repetition range

    High Intensity Resistance Exercise Training, high repetition range, 60 - \<75% 1RM

    Other: HIT-exercise, high repetition range

  • Experimental
    HIT-exercise with protein

    High Intensity Resistance Exercise Training with protein supplementation

    Other: HIT-exercise with protein

  • Placebo comparator
    Control

    No physical exercise intervention

    Other: Control

Interventions

  • OtherHIT-exercise, low repetition range

    High Intensity Resistance Exercise Training, low repetition range, \> 75% 1RM

  • OtherHIT-exercise, high repetition range

    High Intensity Resistance Exercise Training, high repetition range, 60 - \< 75 1RM

  • OtherHIT-exercise with protein

    High Intensity Resistance Exercise Training, low repetition range, \> 75% 1RM and Protein Supplementation

  • OtherControl

    control group, no intervention, maintenance of physical activity

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: 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

    Time frame: change from baseline in CSA upper leg at 5 months

Other outcomes

  1. intra-abdominal fat mass

    intra-abdominal fat mass via Magnetic Resonance Imaging (MRI)

    Time frame: change from baseline in intra-abdominal fat mass at 5 months

  2. maximum strength leg press

    Maximum dynamic strength of the leg extensors/-flexors

    Time frame: change from baseline in maximum strength leg press at 5 months

  3. metabolic syndrome score

    Metabolic Syndrome Score according to Johnson et al.

    Time frame: change from baseline in metabolic syndrome score at 5 months

  4. myocardial mass/enddiastolic volume

    Time frame: change from baseline in myocardial mass/enddiastolic volume at 5 months

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Study locations

1 site
  • Institute of Medical Physics, University of Erlangen-Nurnberg
    Erlangen, 91052, Germany
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References and documents

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 33345059 ↗
  • 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. PubMed 29216285 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01766791
Lead sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Klinikum Nürnberg
Responsible party
Sponsor
First posted
Jan 11, 2013
Start date
Jan 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Mar 21, 2014

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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