Resistance Exercise, Muscle Mass, Strength and Body Composition

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766791
• Other study ID #: PUSH-D-ER
• Secondary ID: Study-098
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2013
• Last updated: March 20, 2014
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: The Bavarian State Ministry of the Environment and Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Sarcopenia

Intervention

Other:
• HIT-exercise, low repetition range
High Intensity Resistance Exercise Training, low repetition range, > 75% 1RM
• HIT-exercise, high repetition range
High Intensity Resistance Exercise Training, high repetition range, 60 - < 75 1RM
• HIT-exercise with protein
High Intensity Resistance Exercise Training, low repetition range, > 75% 1RM and Protein Supplementation
• Control
control group, no intervention, maintenance of physical activity

Locations

Country	Name	City	State
Germany	Institute of Medical Physics, University of Erlangen-Nurnberg	Erlangen

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Klinikum Nürnberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intra-abdominal fat mass	intra-abdominal fat mass via Magnetic Resonance Imaging (MRI)	change from baseline in intra-abdominal fat mass at 5 months	No
Other	maximum strength leg press	Maximum dynamic strength of the leg extensors/-flexors	change from baseline in maximum strength leg press at 5 months	No
Other	metabolic syndrome score	Metabolic Syndrome Score according to Johnson et al.	change from baseline in metabolic syndrome score at 5 months	No
Other	myocardial mass/enddiastolic volume		change from baseline in myocardial mass/enddiastolic volume at 5 months	No
Primary	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)	change from baseline in fat free Cross Sectional Area at 5 months	No
Secondary	CSA upper leg	muscle cross sectional area of the upper leg at mid-femur via QCT	change from baseline in CSA upper leg at 5 months	No