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Home-based Physical Trainings for Reducing Cardiovascular Risk

Primary Purpose

Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
home-based physical training
institutional physical training
Sponsored by
István Kósa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Szeged, Faculty of Health Sciences and Social Studies, Department of PhisiotherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

telemedicine supervised group

institutional training

Arm Description

physical training supervised by telemonitoring

institutional training supervised by physiotherapist

Outcomes

Primary Outcome Measures

waist circumference (WC) navel
waist circumference measured at navel level
Six minutes walk distance (6MWD)
6 minutes walk distance

Secondary Outcome Measures

body parameter 1
body weight measured in kg-s
body parameter 2
hip circumference measured in cm-s
body parameter 3
BMI calculated from weight (kg-s) and height (m-s)
body parameter 4
body composition parameters (fat / muscle / water ratio)
functional parameter 1
stress ECG duration time measured in sec
laboratory parameter 1
glycated haemoglobin (HbA1c) measured in percentage
laboratory parameter 2
fasting plasma glucose (+PG) measured in mmol/l
laboratory parameter 3
triglyceride (TG), measured in mmol/l
laboratory parameter 4
HDL cholesterol, measured in mmol/l
laboratory parameter 5
total-cholesterol measured in mmol/l
psychological test result 1
Anxiety score
psychological test result 2
Depression score
psychological test result 3
vital exhaustion score
psychological test result 4
health locus of control score
psychological test result 5
perceived stress score
psychological test result 6
self-control score

Full Information

First Posted
October 19, 2021
Last Updated
November 23, 2021
Sponsor
István Kósa
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1. Study Identification

Unique Protocol Identification Number
NCT05146076
Brief Title
Home-based Physical Trainings for Reducing Cardiovascular Risk
Official Title
Home-based Physical Trainings for Reducing Cardiovascular Risk
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
István Kósa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
telemedicine supervised group
Arm Type
Experimental
Arm Description
physical training supervised by telemonitoring
Arm Title
institutional training
Arm Type
Active Comparator
Arm Description
institutional training supervised by physiotherapist
Intervention Type
Other
Intervention Name(s)
home-based physical training
Intervention Description
home-based physical training minimum 150 min./week with telemonitoring
Intervention Type
Other
Intervention Name(s)
institutional physical training
Intervention Description
institutional physical training supervised by physiotherapist 2-3 times 60 min./week
Primary Outcome Measure Information:
Title
waist circumference (WC) navel
Description
waist circumference measured at navel level
Time Frame
12 weeks
Title
Six minutes walk distance (6MWD)
Description
6 minutes walk distance
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
body parameter 1
Description
body weight measured in kg-s
Time Frame
12 weeks
Title
body parameter 2
Description
hip circumference measured in cm-s
Time Frame
12 weeks
Title
body parameter 3
Description
BMI calculated from weight (kg-s) and height (m-s)
Time Frame
12 weeks
Title
body parameter 4
Description
body composition parameters (fat / muscle / water ratio)
Time Frame
12 weeks
Title
functional parameter 1
Description
stress ECG duration time measured in sec
Time Frame
12 weeks
Title
laboratory parameter 1
Description
glycated haemoglobin (HbA1c) measured in percentage
Time Frame
12 weeks
Title
laboratory parameter 2
Description
fasting plasma glucose (+PG) measured in mmol/l
Time Frame
12 weeks
Title
laboratory parameter 3
Description
triglyceride (TG), measured in mmol/l
Time Frame
12 weeks
Title
laboratory parameter 4
Description
HDL cholesterol, measured in mmol/l
Time Frame
12 weeks
Title
laboratory parameter 5
Description
total-cholesterol measured in mmol/l
Time Frame
12 weeks
Title
psychological test result 1
Description
Anxiety score
Time Frame
12 weeks
Title
psychological test result 2
Description
Depression score
Time Frame
12 weeks
Title
psychological test result 3
Description
vital exhaustion score
Time Frame
12 weeks
Title
psychological test result 4
Description
health locus of control score
Time Frame
12 weeks
Title
psychological test result 5
Description
perceived stress score
Time Frame
12 weeks
Title
psychological test result 6
Description
self-control score
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: waist circumference (WC) above 102 cm in men and above 88 cm in women proved type 2 diabetes mellitus (T2DM) or fasting plasma glucose level above 5,6 mmol/l treated hypertension or spontaneous blood pressure higher or equivalent than 130/ 85 mmHg treated hypertriglyceridaemia or serum triglyceride level above 1,7 mmol/l 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
István Kósa, Med. habil.
Phone
+36703321652
Email
kosa.istvan@med.u-szeged.hu
First Name & Middle Initial & Last Name or Official Title & Degree
Éva Máthéné Köteles
Phone
+36 30 272 5994
Email
mathene.koteles.eva.szilvia@szte.hu
Facility Information:
Facility Name
University of Szeged, Faculty of Health Sciences and Social Studies, Department of Phisiotherapy
City
Szeged
ZIP/Postal Code
6726
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mária Barnai, Ph.D.
Phone
+36 62 546 416
Email
barnai.maria@szte.hu

12. IPD Sharing Statement

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Home-based Physical Trainings for Reducing Cardiovascular Risk

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