Home-based Physical Trainings for Reducing Cardiovascular Risk

Study Overview
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Brief Summary
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Prospective intervention study among metabolic syndrome patients, investigating the effects of 12 weeks home-based physical training programme with telemonitoring on the anthropometric parameters, the exercise tolerance and other cardio-metabolic risk factors of the metabolic syndrome.

Detailed Description
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Prospective intervention study among metabolic syndrome patients, investigating the effects of 12 weeks home-based physical training programme with telemonitoring on the anthropometric and laboratory parameters, the exercise tolerance and other cardio-metabolic and other psycho-social (anxiety, depression, vital exhaustion , sleep disturbances) risk factors of the metabolic syndrome.

Official Title
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Home-based Physical Trainings for Reducing Cardiovascular Risk

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: home-based physical training
* Other: institutional physical training


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: voluntary patients aged between 25 and 70 years low level of regular physical activity, less than 30 min./ week basic IT skills 3 risk factors present out of the 5 metabolic risk factors from the followings: waist circumference (WC) above 102 cm in men and above 88 cm in women proved type 2 diabetes mellitus (T2DM) or fasting plasma glucose level above 5,6 mmol/l treated hypertension or spontaneous blood pressure higher or equivalent than 130/ 85 mmHg treated hypertriglyceridaemia or serum triglyceride level above 1,7 mmol/l serum HDL cholesterol level under 1,03 mmol/l in men or 1,3 mmol/l in women Exclusion Criteria: any upcoming planned invasive cardiological intervention uncontrolled hypertension type one diabetes mellitus (T1DM) T2DM which needed more than 1 dose insulin per day chronic heart failure chronic renal failure serious cognitive disfunction lack of cooperation any of known disease or condition that seriously affect the mental and legal capacity any other conditions inhibiting regular physical trainings

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telemedicine supervised group<br>physical training supervised by telemonitoring | Other: home-based physical training<br>* home-based physical training minimum 150 min./week with telemonitoring<br>|
| Active Comparator: institutional training<br>institutional training supervised by physiotherapist | Other: institutional physical training<br>* institutional physical training supervised by physiotherapist 2-3 times 60 min./week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference (WC) navel | waist circumference measured at navel level | 12 weeks | 
| Six minutes walk distance (6MWD) | 6 minutes walk distance | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body parameter 1 | body weight measured in kg-s | 12 weeks | 
| body parameter 2 | hip circumference measured in cm-s | 12 weeks | 
| body parameter 3 | BMI calculated from weight (kg-s) and height (m-s) | 12 weeks | 
| body parameter 4 | body composition parameters (fat / muscle / water ratio) | 12 weeks | 
| functional parameter 1 | stress ECG duration time measured in sec | 12 weeks | 
| laboratory parameter 1 | glycated haemoglobin (HbA1c) measured in percentage | 12 weeks | 
| laboratory parameter 2 | fasting plasma glucose (+PG) measured in mmol/l | 12 weeks | 
| laboratory parameter 3 | triglyceride (TG), measured in mmol/l | 12 weeks | 
| laboratory parameter 4 | HDL cholesterol, measured in mmol/l | 12 weeks | 
| laboratory parameter 5 | total-cholesterol measured in mmol/l | 12 weeks | 
| psychological test result 1 | Anxiety score | 12 weeks | 
| psychological test result 2 | Depression score | 12 weeks | 
| psychological test result 3 | vital exhaustion score | 12 weeks | 
| psychological test result 4 | health locus of control score | 12 weeks | 
| psychological test result 5 | perceived stress score | 12 weeks | 
| psychological test result 6 | self-control score | 12 weeks |