Clinical trial NCT05146076: Home-based Physical Trainings for Reducing Cardiovascular Risk
Official title: Home-based Physical Trainings for Reducing Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

  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

Primary outcomes:
measure: waist circumference (WC) navel
timeFrame: 12 weeks
measure: Six minutes walk distance (6MWD)
timeFrame: 12 weeks
Secondary outcomes:
measure: body parameter 1
timeFrame: 12 weeks
measure: body parameter 2
timeFrame: 12 weeks
measure: body parameter 3
timeFrame: 12 weeks
measure: body parameter 4
timeFrame: 12 weeks
measure: functional parameter 1
timeFrame: 12 weeks
measure: laboratory parameter 1
timeFrame: 12 weeks
measure: laboratory parameter 2
timeFrame: 12 weeks
measure: laboratory parameter 3
timeFrame: 12 weeks
measure: laboratory parameter 4
timeFrame: 12 weeks
measure: laboratory parameter 5
timeFrame: 12 weeks
measure: psychological test result 1
timeFrame: 12 weeks
measure: psychological test result 2
timeFrame: 12 weeks
measure: psychological test result 3
timeFrame: 12 weeks
measure: psychological test result 4
timeFrame: 12 weeks
measure: psychological test result 5
timeFrame: 12 weeks
measure: psychological test result 6
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged, Faculty of Health Sciences and Social Studies, Department of Phisiotherapy
Study officials:
References: