IT-Based Training in Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Personal and IT Based Training to Performance, Metabolic Profil and Quality of Life by Patients With Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: Combined 3-monthly endurance and strength training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training Group<br>Combined 3-monthly endurance- (3x/week) and strength training (2x/week) with moderate beginning and continuous increase of volume, duration and intensity, orientated on metabolic equivalents (MET). Main sport: walking, walk and cycling. Addition with other activities are possible up to once a week to achieve the basal metabolism | Other: Combined 3-monthly endurance and strength training<br>* Combined 3-monthly endurance- (3x/week) and strength training (2x/week) with moderate beginning and continuous increase of volume, duration and intensity, orientated on metabolic equivalents (MET). Main sport: walking, walk and cycling. Addition with other activities are possible up to once a week to achieve the basal metabolism<br>|
| No Intervention: Control Group<br>No guided training. Exercise optional after detailed consulting and handing over an information dossier for adequate physical activity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effect of IT based training on metabolic parameters |  | 12 months | 
| Evaluation of the efficacy of IT based training to an increase of activity by patients with impending or manifest metabolic syndrome |  | 12 months | 
| Change in quality of life and subjective assumption of health sensation |  | 12 months | 
| Change in anthropometric parameters |  | 12 months | 
| Raise of maximum performance (max. ergometric performance) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, physical activity, overweight, malnutrition, prevention