Home-based Physical Trainings for Reducing Cardiovascular Risk

Metabolic Syndrome Clinical Trial

Official title:

Home-based Physical Trainings for Reducing Cardiovascular Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146076
• Other study ID #: CV risk physical training
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Metabolic Syndrome

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