Resistance Exercise, Muscle Mass, Strength and Body Composition

NCT01766791 | Completed Phase 3 DMC

• 2 other identifiers: PUSH-D-ERStudy-098
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• CSA upper leg

  change from baseline in CSA upper leg at 5 months

Other Outcomes (4)

• intra-abdominal fat mass

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

• maximum strength leg press

  change from baseline in maximum strength leg press at 5 months

• metabolic syndrome score

  change from baseline in metabolic syndrome score at 5 months

Study Arms (4)

HIT-exercise, low repetition range

EXPERIMENTAL

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

Other: HIT-exercise, low repetition range

HIT-exercise, high repetition range

EXPERIMENTAL

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

Other: HIT-exercise, high repetition range

HIT-exercise with protein

EXPERIMENTAL

High Intensity Resistance Exercise Training with protein supplementation

Other: HIT-exercise with protein

Control

PLACEBO COMPARATOR

No physical exercise intervention

Other: Control

Interventions

HIT-exercise, low repetition range OTHER

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

HIT-exercise, low repetition range

HIT-exercise, high repetition range OTHER

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

HIT-exercise, high repetition range

HIT-exercise with protein OTHER

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

HIT-exercise with protein

Control OTHER

control group, no intervention, maintenance of physical activity

Control

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• males
• untrained (\< 2 h exercise/week, \< 1 h resistance exercise/week)
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Klinikum Nürnberg: collaborator

Study Sites (1)

Institute of Medical Physics, University of Erlangen-Nurnberg

Erlangen, 91052, Germany

Location

Related Publications (2)

• 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.

  PMID: 33345059 DERIVED

• 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.

  PMID: 29216285 DERIVED

MeSH Terms

Conditions

Sarcopenia; Obesity; Coronary Disease

Interventions

Proteins

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Wolfgang Kemmler, PhD

  University of Erlangen-Nürnberg Medical School

  STUDY DIRECTOR

• Andreas Wittke, MA

  University of Erlangen-Nürnberg Medical School

  PRINCIPAL INVESTIGATOR

• Klaus Engelke, PhD

  University of Erlangen-Nürnberg Medical School

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 11, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 21, 2014

Record last verified: 2014-03

Locations

DE (1)