Clinical trial NCT01263522: Optimization of Preventive Effects of Physical Training
Official title: Optimization of Preventive Effects of Physical Training "Saarländische Ausdauer-Etappe (SAusE)"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to Training
Keywords: primary prevention
endurance
cardiovascular risk factors
training
exercise
non-responder
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2010-12-20
Enrollment: 266
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: VO2 max
timeFrame: 6 months
Secondary outcomes:
measure: resting heart rate
timeFrame: 6 months
measure: resting blood pressure
timeFrame: 6 months
measure: blood lipid profile
timeFrame: 6 months
Other outcomes:
Locations:
city: Saarbrücken
country: Germany
facility: Institute of Sports and Preventive Medicine, Saarland University, Bldg. B 8-2, 66123 Saarbrücken
state: Saarland
Study officials:
References:
citation: Wegmann M, Hecksteden A, Poppendieck W, Steffen A, Kraushaar J, Morsch A, Meyer T. Postexercise Hypotension as a Predictor for Long-Term Training-Induced Blood Pressure Reduction: A Large-Scale Randomized Controlled Trial. Clin J Sport Med. 2018 Nov;28(6):509-515. doi: 10.1097/JSM.0000000000000475.
citation: Scharhag-Rosenberger F, Meyer T, Wegmann M, Ruppenthal S, Kaestner L, Morsch A, Hecksteden A. Irisin does not mediate resistance training-induced alterations in resting metabolic rate. Med Sci Sports Exerc. 2014 Sep;46(9):1736-43. doi: 10.1249/MSS.0000000000000286.
citation: 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.