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Resistance Exercise, Muscle Mass, Strength and Body Composition

Primary Purpose

Sarcopenia, Obesity

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

HIT-exercise, low repetition range

HIT-exercise, high repetition range

HIT-exercise with protein

Control

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring resistance exercise, muscle mass, abdominal fat, strength, Coronary Heart Disease (CHD)-risk, myocardial mass

Eligibility Criteria

30 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Institute of Medical Physics, University of Erlangen-Nurnberg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

HIT-exercise, low repetition range

HIT-exercise, high repetition range

HIT-exercise with protein

Control

Arm Description

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

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

High Intensity Resistance Exercise Training with protein supplementation

No physical exercise intervention

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

CSA upper leg

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

Full Information

NCT ID

NCT01766791

First Posted

January 7, 2013

Last Updated

March 20, 2014

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Klinikum Nürnberg

1. Study Identification

Unique Protocol Identification Number

NCT01766791

Brief Title

Resistance Exercise, Muscle Mass, Strength and Body Composition

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Klinikum Nürnberg

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia, Obesity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HIT-exercise, low repetition range

Arm Type

Experimental

Arm Description

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

Arm Title

HIT-exercise, high repetition range

Arm Type

Experimental

Arm Description

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

Arm Title

HIT-exercise with protein

Arm Type

Experimental

Arm Description

High Intensity Resistance Exercise Training with protein supplementation

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

No physical exercise intervention

Intervention Type

Other

Intervention Name(s)

HIT-exercise, low repetition range

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

HIT-exercise, high repetition range

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

HIT-exercise with protein

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

control group, no intervention, maintenance of physical activity

Primary Outcome Measure Information:

Title

fat free Cross Sectional Area (CSA) upper leg

Description

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 Outcome Measure Information:

Title

CSA upper leg

Description

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 Pre-specified Outcome Measures:

Title

intra-abdominal fat mass

Description

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

Time Frame

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

Title

maximum strength leg press

Description

Maximum dynamic strength of the leg extensors/-flexors

Time Frame

change from baseline in maximum strength leg press at 5 months

Title

metabolic syndrome score

Description

Metabolic Syndrome Score according to Johnson et al.

Time Frame

change from baseline in metabolic syndrome score at 5 months

Title

myocardial mass/enddiastolic volume

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfgang Kemmler, PhD

Organizational Affiliation

University of Erlangen-Nürnberg Medical School

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Andreas Wittke, MA

Organizational Affiliation

University of Erlangen-Nürnberg Medical School

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Klaus Engelke, PhD

Organizational Affiliation

University of Erlangen-Nürnberg Medical School

Official's Role

Study Chair

Facility Information:

Facility Name

Institute of Medical Physics, University of Erlangen-Nurnberg

City

Erlangen

ZIP/Postal Code

91052

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

33345059

Citation

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.

Results Reference

derived

PubMed Identifier

29216285

Citation

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.

Results Reference

derived

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Resistance Exercise, Muscle Mass, Strength and Body Composition

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