Metabolic SyndromeNCT05146076
Home-based Physical Trainings for Reducing Cardiovascular Risk
A study testing home-based physical training and institutional physical training in people with Metabolic Syndrome, run by István Kósa at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- home-based physical training and institutional physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHungary
- Study dates
- 1 Nov 2017to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
University of Szeged, Faculty of Health Sciences and Social Studies, Department of Phisiotherapy
Szeged, 6726
Mária Barnai, Ph.D., +36 62 546 416, barnai.maria@szte.hu
About this study
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- home-based physical training, institutional physical training
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based physical trainingOther
home-based physical training minimum 150 min./week with telemonitoring
institutional physical trainingOther
institutional physical training supervised by physiotherapist 2-3 times 60 min./week
| Study group | Role | What they receive |
|---|---|---|
| telemedicine supervised group | Experimental | physical training supervised by telemonitoring Receives: Other: home-based physical training |
| institutional training | Active comparator | institutional training supervised by physiotherapist Receives: Other: institutional physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
waist circumference (WC) navel
waist circumference measured at navel level
Measured: 12 weeks
Six minutes walk distance (6MWD)
6 minutes walk distance
Measured: 12 weeks
Secondary outcomes (16)
body parameter 1
body weight measured in kg-s
Measured: 12 weeks
body parameter 2
hip circumference measured in cm-s
Measured: 12 weeks
body parameter 3
BMI calculated from weight (kg-s) and height (m-s)
Measured: 12 weeks
body parameter 4
body composition parameters (fat / muscle / water ratio)
Measured: 12 weeks
functional parameter 1
stress ECG duration time measured in sec
Measured: 12 weeks
laboratory parameter 1
glycated haemoglobin (HbA1c) measured in percentage
Measured: 12 weeks
laboratory parameter 2
fasting plasma glucose (+PG) measured in mmol/l
Measured: 12 weeks
laboratory parameter 3
triglyceride (TG), measured in mmol/l
Measured: 12 weeks
laboratory parameter 4
HDL cholesterol, measured in mmol/l
Measured: 12 weeks
laboratory parameter 5
total-cholesterol measured in mmol/l
Measured: 12 weeks
psychological test result 1
Anxiety score
Measured: 12 weeks
psychological test result 2
Depression score
Measured: 12 weeks
psychological test result 3
vital exhaustion score
Measured: 12 weeks
psychological test result 4
health locus of control score
Measured: 12 weeks
psychological test result 5
perceived stress score
Measured: 12 weeks
psychological test result 6
self-control score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Nov 2017
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- István Kósa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, István Kósa, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146076
- Sponsor's protocol ID
- CV risk physical training
- Status last verified
- Nov 2021
- First submitted
- 19 Oct 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Physical Trainings for Reducing Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT05146076
- Acronym / sponsor ID
- CV risk physical training
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- István KósaUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telemedicine supervised group | Experimental | Other: home-based physical trainingphysical training supervised by telemonitoring |
| institutional training | Active comparator | Other: institutional physical traininginstitutional training supervised by physiotherapist |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home-based physical traininghome-based physical training minimum 150 min./week with telemonitoring | Other | telemedicine supervised group |
| institutional physical traininginstitutional physical training supervised by physiotherapist 2-3 times 60 min./week | Other | institutional training |
Primary outcome
waist circumference (WC) navel
Time frame: 12 weeks
waist circumference measured at navel level
Six minutes walk distance (6MWD)
Time frame: 12 weeks
6 minutes walk distance
16 secondary outcomes
body parameter 1
Time frame: 12 weeks
body parameter 2
Time frame: 12 weeks
body parameter 3
Time frame: 12 weeks
body parameter 4
Time frame: 12 weeks
functional parameter 1
Time frame: 12 weeks
laboratory parameter 1
Time frame: 12 weeks
laboratory parameter 2
Time frame: 12 weeks
laboratory parameter 3
Time frame: 12 weeks
laboratory parameter 4
Time frame: 12 weeks
laboratory parameter 5
Time frame: 12 weeks
psychological test result 1
Time frame: 12 weeks
psychological test result 2
Time frame: 12 weeks
psychological test result 3
Time frame: 12 weeks
psychological test result 4
Time frame: 12 weeks
psychological test result 5
Time frame: 12 weeks
psychological test result 6
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based physical training and institutional physical training in people with Metabolic Syndrome, run by István Kósa at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact István Kósa, Med. habil. (+36703321652, kosa.istvan@med.u-szeged.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
waist circumference (WC) navel (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.