Resistance Exercise, Muscle Mass, Strength and Body Composition

March 20, 2014 updated by: University of Erlangen-Nürnberg Medical School

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
change from baseline in fat free Cross Sectional Area at 5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from baseline in CSA upper leg at 5 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
change from baseline in intra-abdominal fat mass at 5 months
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
change from baseline in maximum strength leg press at 5 months
metabolic syndrome score
Time Frame: change from baseline in metabolic syndrome score at 5 months
Metabolic Syndrome Score according to Johnson et al.
change from baseline in metabolic syndrome score at 5 months
myocardial mass/enddiastolic volume
Time Frame: change from baseline in myocardial mass/enddiastolic volume at 5 months
change from baseline in myocardial mass/enddiastolic volume at 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimate)

January 11, 2013

Study Record Updates

Last Update Posted (Estimate)

March 21, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUSH-D-ER
  • Study-098 (Other Identifier: University of Erlangen-Nurnberg)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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