Cardiometabolic RiskNCT04359433
Intermittent Exercise Among Students
A study testing Exercise programme in people with Cardiometabolic Risk, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Evaluate the effectiveness of intermittency anaerobic exercise interventions among the students with high risk of cardiometabolic . Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk
- What is being tested?
- Exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2021to Dec 2024
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male: Waist-to-height ratio≥0.463
- Female： Waist-to-height ratio≥0.469
- Students with cardiometabolic risk factors include elevated BP, dyslipidaemia, elevated fasting blood glucose (FBG) and central obesity.
Who cannot join
- Participates with severe disease conditions include cardiac insufficiency, respiratory system relate diseases, immunodeficiency or severe malnutrition, ect
- Taking or having taken weight-loss drugs
- Participates unsuitable or improper to participate the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Effectiveness of Intermittent Anaerobic Exercise Among the Students With Cardiometabolic Risk
Evaluate the effectiveness of intermittency anaerobic exercise interventions among the students with high risk of cardiometabolic .
- Conditions
- Cardiometabolic Risk
- Being tested
- Exercise programme
- Keywords
- cardiometabolic, children, Waist to height ratio, WHtR, Intermittent Anaerobic Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programmeBehavioural
Exercise programme includes 8 anaerobic movements choosen from Tabata. This exercise programme workout is aimed at body fat reduction, and the structure is as follows:
- 8 anerobic movements in 20 seconds is a set
- Rest for 10 seconds before another set
- Finish 4 sets every time, it shall take you 4 minutes
- Do 4 sets 2 to 3 times a week
| Study group | Role | What they receive |
|---|---|---|
| Standard group | No intervention | The participates in this group would provide normal health education of scientific and rational diet. |
| Exercise intervention group | Experimental | Besides normal health education of scientific and rational diet，the participates in this group would be suggested to carry out an anaerobic exercise named Tabata. Receives: Behavioral: Exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal of cardiometabolic risk related index
Cardiometabolic risk related index includes fasting blood glucose, blood lipids, blood pressure and abdominal obesity.Cardiometabolic risk related index would be set to 1 as at least 2 indexs mentioned were abnormal while 0 for less than 2.
Measured: 3th month after enrollment
Secondary outcomes (3)
Change of Waist-to-height ratio
Waist-to-height ratio is calculated by the formula ：Waist-to-height ratio=waistline (cm)/height(cm). All the participates' Waist-to-height ratio would be calculated at baseline and 12th months after enrollment. The change would be manifested in the situatuion of the difference.
Measured: Baseline, 12th months after enrollment
Change of Body Mass Index
Body Mass Index is calculated by the formula ：Body Mass Index=weight(kg)/(height(cm))^2. All the participates' Body Mass Index would be calculated at baseline and 12th months after enrollment. The change would be manifested in the situatuion of the difference.
Measured: Baseline, 12th months after enrollment
Change of hipline
All the participates' hipline would be measured at baseline and 12th months after enrollment. The change would be manifested in the situatuion of the difference.
Measured: Baseline, 12th months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start2 Aug 2021
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Funding issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic RiskStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weili Yan, PhD, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359433
- Sponsor's protocol ID
- IES-EKYY
- Status last verified
- May 2024
- First submitted
- 21 Apr 2020
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effectiveness of Intermittent Anaerobic Exercise Among the Students With Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT04359433
- Acronym / sponsor ID
- IES-EKYY
- Conditions
- Cardiometabolic Risk
- Keywords
- cardiometabolic, children, Waist to height ratio, WHtR, Intermittent Anaerobic Exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Apr 2020 (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.
Evaluate the effectiveness of intermittency anaerobic exercise interventions among the students with high risk of cardiometabolic .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | No intervention | –The participates in this group would provide normal health education of scientific and rational diet. |
| Exercise intervention group | Experimental | Behavioral: Exercise programmeBesides normal health education of scientific and rational diet，the participates in this group would be suggested to carry out an anaerobic exercise named Tabata. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male: Waist-to-height ratio≥0.463
- Female： Waist-to-height ratio≥0.469
- Students with cardiometabolic risk factors include elevated BP, dyslipidaemia, elevated fasting blood glucose (FBG) and central obesity.
Key exclusion criteria (3 listed)
- Participates with severe disease conditions include cardiac insufficiency, respiratory system relate diseases, immunodeficiency or severe malnutrition, ect
- Taking or having taken weight-loss drugs
- Participates unsuitable or improper to participate the study
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 |
|---|---|---|
| Exercise programmeExercise programme includes 8 anaerobic movements choosen from Tabata. This exercise programme workout is aimed at body fat reduction, and the structure is as follows: * 8 anerobic movements in 20 seconds is a set * Rest for 10 seconds before another set * Finish 4 sets every time, it shall take you 4 minutes * Do 4 sets 2 to 3 times a week | Behavioural | Exercise intervention group |
Primary outcome
Abnormal of cardiometabolic risk related index
Time frame: 3th month after enrollment
Cardiometabolic risk related index includes fasting blood glucose, blood lipids, blood pressure and abdominal obesity.Cardiometabolic risk related index would be set to 1 as at least 2 indexs mentioned were abnormal while 0 for less than 2.
3 secondary outcomes
Change of Waist-to-height ratio
Time frame: Baseline, 12th months after enrollment
Change of Body Mass Index
Time frame: Baseline, 12th months after enrollment
Change of hipline
Time frame: Baseline, 12th months after enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Weili Yan, PhD study chair
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise programme in people with Cardiometabolic Risk, run by Children's Hospital of Fudan University at 1 site in China.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 May 2024. 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 China. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal of cardiometabolic risk related index (time frame: 3th month after enrollment). 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 14 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.