CompletedNCT01263522SAusEUpdated May 11, 2018

Optimization of Preventive Effects of Physical Training

An interventional study of different training programs and control condition in Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to Training, sponsored by Universität des Saarlandes. Completed at 1 site in Germany. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-11.

Sponsored by Universität des Saarlandes · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 266
Allocation: Randomized
Ages: 30 Years to 60 Years
Sex: All

Study 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.

Conditions studied

Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to Training

Keywords

primary prevention
endurance
cardiovascular risk factors
training
exercise
non-responder

In context

Lead sponsor

Universität des Saarlandes is the lead sponsor of 64 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

untrained
healthy
non-smoking

Exclusion criteria

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 design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 266 participants (actual)

Study arms

Experimental
Endurance training
Other: different training programs
Experimental
interval training
Other: different training programs
Experimental
strength endurance training
Other: different training programs
Placebo comparator
control
Other: control condition

Interventions

Otherdifferent training programs
two different endurance programs and one strength endurance program
Othercontrol condition
unchanged lifestyle

What researchers measure

Primary outcomes

VO2 max
determined during treadmill testing
Time frame: 6 months

Secondary outcomes

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

Study locations

1 site

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

References and documents

Publications

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. PubMed 29189337 ↗
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. PubMed 24566753 ↗
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. PubMed 24191966 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01263522
Lead sponsor: Universität des Saarlandes
Responsible party: Sponsor
First posted: Dec 20, 2010
Start date: Dec 2010
Primary completion: Dec 2013
Completion: Dec 2013
Last update: May 11, 2018

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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