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NCT Number: NCT01766791

Resistance Exercise, Muscle Mass, Strength and Body Composition

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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Key information

Conditions

Sarcopenia Atrophy Body Weight Cardiovascular Diseases Coronary Disease Heart Diseases Muscular Atrophy Myocardial Ischemia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Medical Physics, University of Erlangen-Nurnberg

Erlangen, 91052, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIT-exercise, low repetition range

Other

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

HIT-exercise, high repetition range

Other

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

HIT-exercise with protein

Other

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

Control

Other

control group, no intervention, maintenance of physical activity

Primary outcomes

  1. 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)

Secondary outcomes

  1. CSA upper leg

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

    muscle cross sectional area of the upper leg at mid-femur via QCT

Other outcomes

  1. intra-abdominal fat mass

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

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

  2. maximum strength leg press

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

    Maximum dynamic strength of the leg extensors/-flexors

  3. metabolic syndrome score

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

    Metabolic Syndrome Score according to Johnson et al.

  4. myocardial mass/enddiastolic volume

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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • Klinikum Nürnberg

Registry information

Official study title

Effects of Resistance Exercise on Muscle Mass, Strength, Body Composition and Heart in Men 30-50 Years Old.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 11, 2013
Registry last updated
Mar 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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