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

December 17, 2010
December 17, 2010
December 2010
December 2012   (final data collection date for primary outcome measure)
VO2max [ Time Frame: 6 months ] [ Designated as safety issue: No ]
determined during treadmill testing
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Optimization of Preventive Effects of Physical Training
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to Training
  • Other: different training programs
    two different endurance programs and one strength endurance program
  • Other: control condition
    unchanged lifestyle
  • Experimental: Endurance training
    Intervention: Other: different training programs
  • Experimental: interval training
    Intervention: Other: different training programs
  • Experimental: strength endurance training
    Intervention: Other: different training programs
  • Placebo Comparator: control
    Intervention: Other: control condition
Hecksteden A, Wegmann M, Steffen A, Kraushaar J, Morsch A, Ruppenthal S, Kaestner L, Meyer T. Irisin and exercise training in humans - results from a randomized controlled training trial. BMC Med. 2013 Nov 5;11:235. doi: 10.1186/1741-7015-11-235.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
December 2012   (final data collection date for primary outcome measure)

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

Both
30 Years to 60 Years
Yes
Not Provided
Germany
 
NCT01263522
SAusE2011
Not Provided
Institute of Sports and Preventive Medicine, Saarland University, Bldg. B 8-2, 66123 Saarbrücken, Germany, Saarland University
Saarland University
Not Provided
Not Provided
Saarland University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP