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Resistance Exercise, Muscle Mass, Strength and Body Composition

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ClinicalTrials.gov Identifier: NCT01766791
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : March 21, 2014
Sponsor:
Collaborator:
Klinikum Nürnberg
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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.


Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Resistance Exercise on Muscle Mass, Strength, Body Composition and Heart in Men 30-50 Years Old.
Study Start Date : January 2013
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766791


Locations
Germany
Institute of Medical Physics, University of Erlangen-Nurnberg
Erlangen, Germany, 91052
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01766791     History of Changes
Other Study ID Numbers: PUSH-D-ER
Study-098 ( Other Identifier: University of Erlangen-Nurnberg )
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: March 21, 2014
Last Verified: March 2014

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:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms