Clinical trial NCT00686244: IT-Based Training in Metabolic Syndrome
Official title: Effect of Personal and IT Based Training to Performance, Metabolic Profil and Quality of Life by Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
physical activity
overweight
malnutrition
prevention
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2008-05-29
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective, randomized, single center, controlled intervention study to investigate the effect of a systematic combined personal and IT-based training on the outcome of patients with metabolic syndrome.

Detailed description: The study settles in the field of primary prevention and aims to change lifestyle of patients with metabolic syndrome with a new combination of personal and IT-based training specially designed für obese people with risk factors. Procedures that are similar for all participants are summarized in a training program whereas individual aspects of physical activity like initial education and exercise tests are still performed by doctors and trainers. Before and after three months of training anthropometric parameters, laboratory and exercise capacity are examined and analyzed. The intervention group is characterized by a predetermined exercise program whereas the control group is allowed to practise without detailed instructions. The practicability and the effect on health status of the combined personal and IT-based training in the intervention group is compared with the independent training of the control group. After 6 months and again after 12 months the measurements are repeated to evaluate a lasting effect of the program.

Eligibility criteria: Inclusion Criteria:

* males and females between 20 and 60 years
* Staff of the Fa. BMW
* written informed consent after detailed education
* BMI 25-35 kg/m2
* ≤ 1x/week sport respectively exercise
* metabolic syndrome (at least 3 of 5 criteria)

Exclusion Criteria:

* \> 1x/week physical activity
* BMI \< 25 kg/m2 or \> 35 kg/m2
* Florid acute or chronic disease of any kind prohibiting regular physical activity
* Diabetes mellitus
* pregnancy or lactation
* Drug or alcohol abuse

Primary outcomes:
measure: Evaluation of the effect of a combined personal and IT- based training on the performance at the metabolic anaerobe barrier of patients with impending or manifest metabolic syndrome compared to a control group with conventional consulting
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of the effect of IT based training on metabolic parameters
timeFrame: 12 months
measure: Evaluation of the efficacy of IT based training to an increase of activity by patients with impending or manifest metabolic syndrome
timeFrame: 12 months
measure: Change in quality of life and subjective assumption of health sensation
timeFrame: 12 months
measure: Change in anthropometric parameters
timeFrame: 12 months
measure: Raise of maximum performance (max. ergometric performance)
timeFrame: 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Lehrstuhl für Praeventive und Rehabilitative Sportmedizin Klinikum Rechts der Isar, Technical University of Munich
Study officials:
affiliation: Department of Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
name: Martin Halle, P.D.
role: PRINCIPAL_INVESTIGATOR
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