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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05146076
Other study ID # CV risk physical training
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date July 1, 2022

Study information

Verified date November 2021
Source Szeged University
Contact István Kósa, Med. habil.
Phone +36703321652
Email kosa.istvan@med.u-szeged.hu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date July 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 25 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
home-based physical training
home-based physical training minimum 150 min./week with telemonitoring
institutional physical training
institutional physical training supervised by physiotherapist 2-3 times 60 min./week

Locations

Country Name City State
Hungary University of Szeged, Faculty of Health Sciences and Social Studies, Department of Phisiotherapy Szeged

Sponsors (1)

Lead Sponsor Collaborator
István Kósa

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary waist circumference (WC) navel waist circumference measured at navel level 12 weeks
Primary Six minutes walk distance (6MWD) 6 minutes walk distance 12 weeks
Secondary body parameter 1 body weight measured in kg-s 12 weeks
Secondary body parameter 2 hip circumference measured in cm-s 12 weeks
Secondary body parameter 3 BMI calculated from weight (kg-s) and height (m-s) 12 weeks
Secondary body parameter 4 body composition parameters (fat / muscle / water ratio) 12 weeks
Secondary functional parameter 1 stress ECG duration time measured in sec 12 weeks
Secondary laboratory parameter 1 glycated haemoglobin (HbA1c) measured in percentage 12 weeks
Secondary laboratory parameter 2 fasting plasma glucose (+PG) measured in mmol/l 12 weeks
Secondary laboratory parameter 3 triglyceride (TG), measured in mmol/l 12 weeks
Secondary laboratory parameter 4 HDL cholesterol, measured in mmol/l 12 weeks
Secondary laboratory parameter 5 total-cholesterol measured in mmol/l 12 weeks
Secondary psychological test result 1 Anxiety score 12 weeks
Secondary psychological test result 2 Depression score 12 weeks
Secondary psychological test result 3 vital exhaustion score 12 weeks
Secondary psychological test result 4 health locus of control score 12 weeks
Secondary psychological test result 5 perceived stress score 12 weeks
Secondary psychological test result 6 self-control score 12 weeks
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