SAusE: Optimization of Preventive Effects of Physical Training

Sponsor

Universität des Saarlandes (Other)

Overall Status

Completed

CT.gov ID

NCT01263522

Collaborator

(none)

266

Enrollment

Location

Arms

Actual Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to Training	Other: different training programs Other: control condition	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

266 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

VO2 max [6 months]
determined during treadmill testing

Secondary Outcome Measures

resting heart rate [6 months]
resting blood pressure [6 months]
blood lipid profile [6 months]
ratio: total cholesterol/HDL-cholesterol

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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