Home-based Physical Trainings for Reducing Cardiovascular Risk

Not Applicable

• Conditions: Metabolic Syndrome
• Interventions: Other: institutional physical training; Other: home-based physical training

• Registration Number: NCT05146076
• Lead Sponsor: István Kósa

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.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2021-10-19
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-23
• Last Update Submitted: 2021-11-23
• Study First Posted: 2021-12-06
• Last Update Posted: 2021-12-06
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
institutional training	institutional physical training	institutional training supervised by physiotherapist
telemedicine supervised group	home-based physical training	physical training supervised by telemonitoring

Primary Outcome Measures

Name	Time	Method
waist circumference (WC) navel	12 weeks	waist circumference measured at navel level
Six minutes walk distance (6MWD)	12 weeks	6 minutes walk distance

Secondary Outcome Measures

Name	Time	Method
laboratory parameter 1	12 weeks	glycated haemoglobin (HbA1c) measured in percentage
laboratory parameter 4	12 weeks	HDL cholesterol, measured in mmol/l
laboratory parameter 2	12 weeks	fasting plasma glucose (+PG) measured in mmol/l
laboratory parameter 3	12 weeks	triglyceride (TG), measured in mmol/l
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)
body parameter 1	12 weeks	body weight measured in kg-s
functional parameter 1	12 weeks	stress ECG duration time measured in sec
laboratory parameter 5	12 weeks	total-cholesterol measured in mmol/l
psychological test result 1	12 weeks	Anxiety score
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
psychological test result 6	12 weeks	self-control score

Trial Locations

Locations (1)

University of Szeged, Faculty of Health Sciences and Social Studies, Department of Phisiotherapy; 🇭🇺 Szeged, Hungary