Home-based Physical Trainings for Reducing Cardiovascular Risk
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 19, 2021
CompletedFirst Posted
Study publicly available on registry
December 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedDecember 6, 2021
November 1, 2021
4.7 years
October 19, 2021
November 23, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
waist circumference (WC) navel
waist circumference measured at navel level
12 weeks
Six minutes walk distance (6MWD)
6 minutes walk distance
12 weeks
Secondary Outcomes (16)
body parameter 1
12 weeks
body parameter 2
12 weeks
body parameter 3
12 weeks
body parameter 4
12 weeks
functional parameter 1
12 weeks
- +11 more secondary outcomes
Study Arms (2)
telemedicine supervised group
EXPERIMENTALphysical training supervised by telemonitoring
institutional training
ACTIVE COMPARATORinstitutional training supervised by physiotherapist
Interventions
home-based physical training minimum 150 min./week with telemonitoring
institutional physical training supervised by physiotherapist 2-3 times 60 min./week
Eligibility Criteria
You may qualify if:
- voluntary patients aged between 25 and 70 years
- low level of regular physical activity, less than 30 min./ week
- basic IT skills
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- István Kósalead
Study Sites (1)
University of Szeged, Faculty of Health Sciences and Social Studies, Department of Phisiotherapy
Szeged, 6726, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of Department of Medical Prevention
Study Record Dates
First Submitted
October 19, 2021
First Posted
December 6, 2021
Study Start
November 1, 2017
Primary Completion
July 1, 2022
Study Completion
July 1, 2022
Last Updated
December 6, 2021
Record last verified: 2021-11