Optimization of Preventive Effects of Physical Training (SAusE)

May 4, 2018 updated by: Universität des Saarlandes

Optimization of Preventive Effects of Physical Training "Saarländische Ausdauer-Etappe (SAusE)"

Health-promoting effects of physical exercise are well-investigated especially for endurance activities. However, for different individuals, positive effects have different sizes, even non-responders are observed. Other forms of training, such as strength training and interval training, are less well investigated. Therefore, a comparative longitudinal training study is warranted to examine differences of preventive effects (outcome measures: ergometric descriptors of physical performance, established risk factors and prognostic factors for cardiovascular diseases) of continuous endurance training, interval training and strength endurance training.

In a second stage, the observed non-responders will perform a different type of training (cross-over). It is expected, that besides a comparative general efficacy evaluation of the three training types, improved recommendations for optimized individualization of training parameters can be formulated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Not Applicable

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
    • Saarland
      • Saarbrücken, Saarland, Germany, 66123
        • Institute of Sports and Preventive Medicine, Saarland University, Bldg. B 8-2, 66123 Saarbrücken

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 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • untrained
  • healthy
  • non-smoking

Exclusion Criteria:

  • Contraindications for physical activity
  • BMI > 30 kg/m2
  • resting blood pressure > 160/100 mmHg
  • diabetes
  • total cholesterol > 300 mg/dl
  • maximal oxygen uptake > 50 ml/min/kg for men and > 45 ml/min/kg for women respectively
  • other complaints or diseases that might interfere with exercise training

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control
Other: control condition
unchanged lifestyle
Experimental: Endurance training
Other: different training programs
two different endurance programs and one strength endurance program
Experimental: interval training
Other: different training programs
two different endurance programs and one strength endurance program
Experimental: strength endurance training
Other: different training programs
two different endurance programs and one strength endurance program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2 max
Time Frame: 6 months
determined during treadmill testing
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resting heart rate
Time Frame: 6 months
6 months
resting blood pressure
Time Frame: 6 months
6 months
blood lipid profile
Time Frame: 6 months
ratio: total cholesterol/HDL-cholesterol
6 months

Collaborators and Investigators

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

Sponsor

Universität des Saarlandes

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 (Actual)

December 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 17, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (Estimate)

December 20, 2010

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SAusE2011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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