Home-based Physical Trainings for Reducing Cardiovascular Risk

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: home-based physical training; Other: institutional physical training

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: István Kósa, Med. habil.; Phone Number: +36703321652; Email: kosa.istvan@med.u-szeged.hu
• Study Contact Backup: Name: Éva Máthéné Köteles; Phone Number: +36 30 272 5994; Email: mathene.koteles.eva.szilvia@szte.hu

Study Locations

• Hungary
  • Szeged, Hungary, 6726
    • Recruiting
    • University of Szeged, Faculty of Health Sciences and Social Studies, Department of Phisiotherapy
    • Contact: Mária Barnai, Ph.D.; Phone Number: +36 62 546 416; Email: barnai.maria@szte.hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: István Kósa

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: CV risk physical training

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No