Optimization of Preventive Effects of Physical Training (SAusE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Saarland University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Saarland University
ClinicalTrials.gov Identifier:
NCT01263522
First received: December 17, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to Training
Other: different training programs
Other: control condition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Optimization of Preventive Effects of Physical Training "Saarländische Ausdauer-Etappe (SAusE)"

Resource links provided by NLM:


Further study details as provided by Saarland University:

Primary Outcome Measures:
  • VO2max [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    determined during treadmill testing


Secondary Outcome Measures:
  • resting heart rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • resting blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • blood lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    ratio: total cholesterol/HDL-cholesterol


Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: control Other: control condition
unchanged lifestyle

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: untrained, healthy and non-smoking men and women

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263522

Locations
Germany
Institute of Sports and Preventive Medicine, Saarland University, Bldg. B 8-2, 66123 Saarbrücken Recruiting
Saarbrücken, Saarland, Germany, 66123
Contact: Tim Meyer, Prof. Dr. med.    (0)681 - 302 3750 ext +49    tim.meyer@mx.uni-saarland.de   
Sponsors and Collaborators
Saarland University
  More Information

No publications provided by Saarland University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institute of Sports and Preventive Medicine, Saarland University, Bldg. B 8-2, 66123 Saarbrücken, Germany, Saarland University
ClinicalTrials.gov Identifier: NCT01263522     History of Changes
Other Study ID Numbers: SAusE2011
Study First Received: December 17, 2010
Last Updated: December 17, 2010
Health Authority: Germany: Ethics Committee

Keywords provided by Saarland University:
primary prevention
endurance
cardiovascular risk factors
training
exercise
non-responder

ClinicalTrials.gov processed this record on July 22, 2014