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Resistance Exercise, Muscle Mass, Strength and Body Composition

This study is currently recruiting participants.
Verified January 2013 by University of Erlangen-Nürnberg Medical School
Sponsor:
Collaborator:
Klinikum Nürnberg
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01766791
First received: January 7, 2013
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Sarcopenia
Obesity
 Other: HIT-exercise, low repetition range
Other: HIT-exercise, high repetition range
Other: HIT-exercise with protein
Other: Control
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Resistance Exercise on Muscle Mass, Strength, Body Composition and Heart in Men 30-50 Years Old.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • fat free Cross Sectional Area (CSA) upper leg [ Time Frame: change from baseline in fat free Cross Sectional Area at 5 months ] [ Designated as safety issue: No ]
    fat free muscle cross sectional area of the upper leg at mid-femur via Quantitative Computed Tomography (QCT)


Secondary Outcome Measures:
  • CSA upper leg [ Time Frame: change from baseline in CSA upper leg at 5 months ] [ Designated as safety issue: No ]
    muscle cross sectional area of the upper leg at mid-femur via QCT


Other Outcome Measures:
  • intra-abdominal fat mass [ Time Frame: change from baseline in intra-abdominal fat mass at 5 months ] [ Designated as safety issue: No ]
    intra-abdominal fat mass via Magnetic Resonance Imaging (MRI)

  • maximum strength leg press [ Time Frame: change from baseline in maximum strength leg press at 5 months ] [ Designated as safety issue: No ]
    Maximum dynamic strength of the leg extensors/-flexors

  • metabolic syndrome score [ Time Frame: change from baseline in metabolic syndrome score at 5 months ] [ Designated as safety issue: No ]
    Metabolic Syndrome Score according to Johnson et al.

  • myocardial mass/enddiastolic volume [ Time Frame: change from baseline in myocardial mass/enddiastolic volume at 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
High Intensity Resistance Exercise Training, low repetition range, > 75% 1RM
Experimental: HIT-exercise, high repetition range
High Intensity Resistance Exercise Training, high repetition range, 60 - <75% 1RM
 Other: HIT-exercise, high repetition range
High Intensity Resistance Exercise Training, high repetition range, 60 - < 75 1RM
Experimental: HIT-exercise with protein
High Intensity Resistance Exercise Training with protein supplementation
 Other: HIT-exercise with protein
High Intensity Resistance Exercise Training, low repetition range, > 75% 1RM and Protein Supplementation
Placebo Comparator: Control
No physical exercise intervention
 Other: Control
control group, no intervention, maintenance of physical activity

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766791

Contacts
Contact: Wolfgang Kemmler, PhD 0049 9131 8523999 wolfgang.kemmler@imp.uni-erlangen.de
Contact: Simon von Stengel, PhD 0049 9131 8523999 simon@imp.uni-erlangen.de

Locations
Germany
Institute of Medical Physics, University of Erlangen-Nurnberg Recruiting
Erlangen, Germany, 91052
Contact: Andreas Wittke, PhD     0049 9131 8525513     andreas.wittke@imp.uni-erlangen.de    
Contact: Simon von Stengel, PhD     0049 9131 8523999     simon@imp.uni-erlangen.de    
Principal Investigator: Scharf Michael, MD            
Principal Investigator: Michael Lell, MD            
Principal Investigator: Bernd Langenstein, MD            
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Klinikum Nürnberg
Investigators
Study Director: Wolfgang Kemmler, PhD University of Erlangen-Nürnberg Medical School
Principal Investigator: Andreas Wittke, MA University of Erlangen-Nürnberg Medical School
Study Chair: Klaus Engelke, PhD University of Erlangen-Nürnberg Medical School
  More Information

No publications provided

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01766791     History of Changes
Other Study ID Numbers: PUSH-D-ER, Study-098
Study First Received: January 7, 2013
Last Updated: January 14, 2013
Health Authority: Germany: The Bavarian State Ministry of the Environment and Public Health

Keywords provided by University of Erlangen-Nürnberg Medical School:
resistance exercise
muscle mass
abdominal fat
 strength
Coronary Heart Disease (CHD)-risk
myocardial mass

Additional relevant MeSH terms:
Obesity
Sarcopenia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013