Metabolic Syndrome
Conditions
Brief summary
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
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.
Interventions
home-based physical training minimum 150 min./week with telemonitoring
OTHERinstitutional physical training
institutional physical training supervised by physiotherapist 2-3 times 60 min./week
Sponsors
István Kósa
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
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: 1. waist circumference (WC) above 102 cm in men and above 88 cm in women 2. proved type 2 diabetes mellitus (T2DM) or fasting plasma glucose level above 5,6 mmol/l 3. treated hypertension or spontaneous blood pressure higher or equivalent than 130/ 85 mmHg 4. treated hypertriglyceridaemia or serum triglyceride level above 1,7 mmol/l 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| waist circumference (WC) navel | 12 weeks | waist circumference measured at navel level |
| Six minutes walk distance (6MWD) | 12 weeks | 6 minutes walk distance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body parameter 2 | 12 weeks | hip circumference measured in cm-s |
| body parameter 3 | 12 weeks | BMI calculated from weight (kg-s) and height (m-s) |
| body parameter 4 | 12 weeks | body composition parameters (fat / muscle / water ratio) |
| functional parameter 1 | 12 weeks | stress ECG duration time measured in sec |
| psychological test result 2 | 12 weeks | Depression score |
| psychological test result 3 | 12 weeks | vital exhaustion score |
| psychological test result 4 | 12 weeks | health locus of control score |
| psychological test result 5 | 12 weeks | perceived stress score |
| laboratory parameter 2 | 12 weeks | fasting plasma glucose (+PG) measured in mmol/l |
| laboratory parameter 3 | 12 weeks | triglyceride (TG), measured in mmol/l |
| laboratory parameter 4 | 12 weeks | HDL cholesterol, measured in mmol/l |
| laboratory parameter 5 | 12 weeks | total-cholesterol measured in mmol/l |
| psychological test result 1 | 12 weeks | Anxiety score |
| psychological test result 6 | 12 weeks | self-control score |
| laboratory parameter 1 | 12 weeks | glycated haemoglobin (HbA1c) measured in percentage |
| body parameter 1 | 12 weeks | body weight measured in kg-s |
Countries
Hungary
Contacts
Primary ContactIstván Kósa, Med. habil.
Backup ContactÉva Máthéné Köteles
Outcome results
None listed