Home-based Physical Trainings for Reducing Cardiovascular Risk

NCT ID: NCT05146076

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2022-07-01

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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telemedicine supervised group

physical training supervised by telemonitoring

Group Type EXPERIMENTAL

home-based physical training

Intervention Type OTHER

home-based physical training minimum 150 min./week with telemonitoring

institutional training

institutional training supervised by physiotherapist

Group Type ACTIVE_COMPARATOR

institutional physical training

Intervention Type OTHER

institutional physical training supervised by physiotherapist 2-3 times 60 min./week

Interventions

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home-based physical training

home-based physical training minimum 150 min./week with telemonitoring

Intervention Type OTHER

institutional physical training

institutional physical training supervised by physiotherapist 2-3 times 60 min./week

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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István Kósa

OTHER

Sponsor Role lead

Responsible Party

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István Kósa

Head of Department of Medical Prevention

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Szeged, Faculty of Health Sciences and Social Studies, Department of Phisiotherapy

Szeged, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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István Kósa, Med. habil.

Role: CONTACT

Phone: +36703321652

Email: [email protected]

Éva Máthéné Köteles

Role: CONTACT

Phone: +36 30 272 5994

Email: [email protected]

Facility Contacts

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Mária Barnai, Ph.D.

Role: primary

Other Identifiers

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CV risk physical training

Identifier Type: -

Identifier Source: org_study_id