Home-based Physical Trainings for Reducing Cardiovascular Risk

István Kósa

Status: Unknown

Conditions: Metabolic Syndrome

Treatments: Other: institutional physical training; Other: home-based physical training

Study type: Interventional

Funder types: Other

Identifiers

NCT05146076

CV risk physical training

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

telemedicine supervised group

Experimental group

Description:

physical training supervised by telemonitoring

Treatment:

Other: home-based physical training

institutional training

Active Comparator group

Description:

institutional training supervised by physiotherapist

Treatment:

Other: institutional physical training