Normal Weight ObesityNCT06556875
Regulation of HIIT Combined with IET on Vascular Function in Young Women with Normal Weight Obesity
A study testing HIIT and HIIT combined IET in people with Normal Weight Obesity, run by Beijing Sport University at 1 site in China.
Trial summary
Comparison of the effects of combined IET with HIIT and HIIT on vascular function in young NWO women. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Weight Obesity
- What is being tested?
- HIIT and HIIT combined IET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2023to 30 Dec 2023
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, aged between 18 and 30 years old;
- BMI between 18.5 and 24.9 kg/m2 with a BF% > 30% (normal weight obesity determination criteria);
- exercise capacity to complete the exercise programme.
Who cannot join
- Acute or chronic musculoskeletal disorders, cardiovascular diseases, etc. that prevented training;
- other diseases (such as diabetes, etc.) that had a great impact on physical condition;
- bad habits (such as smoking, drinking, etc.);
- and unstable body weight (up and down fluctuations of more than 2.5 kg) in the 3 months before the experiment.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Sports Medicine and Rehabilitation, Beijing Sport University
Beijing
About this study
Comparison of the effects of combined IET with HIIT and HIIT on vascular function in young NWO women.
Read the detailed description
This is a randomized clinical trial of single-blind with 3 arms (control group , HIIT group and IET with HIIT group), in which a pre-treatment-posttest design has been used.
- Conditions
- Normal Weight Obesity
- Being tested
- HIIT, HIIT combined IET
- Keywords
- isometric exercise training, high-intensity interval training, normal weight obesity, vascular fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITBehavioural
high intensity interval training
HIIT combined IETBehavioural
high intensity interval training combined with isometric exercise training
| Study group | Role | What they receive |
|---|---|---|
| HIIT group | Active comparator | Not described Receives: Behavioral: HIIT |
| HIIT combined IET group | Active comparator | Not described Receives: Behavioral: HIIT combined IET |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intima-Media Thickness (IMT)
The subjects were required to sit still for 5～10 minutes before the test, and the carotid artery structural and functional parameters were recorded using a GE vivid 7 colour ultrasound instrument from the United States as follows: the subjects were required to lie in the supine position, and the probe was used to sweep longitudinally along the outer edge of the sternocleidomastoid muscle, and the maximal Intima-media thickness (IMT) was measured. Changes in Intima media thickness before and after intervention.
Measured: 8 weeks
Flow-Mediated Dilation (FMD)
Vascular endothelial function was measured with a Japanese-made UNEX EF vascular endothelial function tester. Pressure was applied on top of the resting blood pressure and the ischaemic process was performed for 5 min. At the end of the ischaemic process, the pressure band was removed and flow-mediated dilation (FMD) of the brachial artery was calculated. Changes in Flow-mediated dilation before and after Intervention
Measured: 8 weeks
Secondary outcomes (5)
Body Composition Indicators
Body composition indicators analysis was assessed using DXA. Body composition indicators include: fat mass(kg), lean body mass(kg), percentage of body fat(%).
Measured: 8 weeks
Body Mass Index (BMI)
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat. Changes in Body mass index before and after Intervention.
Measured: 8 weeks
Blood Pressure (BP)
Quiet blood pressure: Systolic and diastolic blood pressures are measured using a standard mercury sphygmomanometer. Changes in blood pressure before and after intervention, including systolic blood pressure, diastolic blood pressure, and pulse pressure difference.
Measured: 8 weeks
Pulse Wave Velocity (PWV) and ankle brachial index (ABI)
The testing instrument is Omron Atherosclerosis Tester (BP-203RPEIII). During the test, the subjects need to expose their limbs, lie flat on the bed, and keep their bodies relaxed. At the same time, they need to tie cuffs around their limbs to avoid any physical movement and ensure the accuracy of the test results. The unit of PWV is (cm/s), and ABI is a numerical value. Changes in Pulse wave velocity and ankle brachial index before and after Intervention.
Measured: 8 weeks
Volume Oxygen Maximum (VO2max)
During the test, gradually increasing loads were performed using the Bruce running table protocol, and gas metabolism metrics were obtained at each stage of exercise using a portable Cortex-3B gas metabolism analyser. Changes in Volume oxygen maximum before and after Intervention.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start23 Feb 2023
- Primary completion30 Sep 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Weight ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556875
- Sponsor's protocol ID
- RHCIVFYWNWO
- Status last verified
- Feb 2023
- First submitted
- 27 Jul 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of HIIT Combined with IET on Vascular Function in Young Women with Normal Weight Obesity
- ClinicalTrials.gov ID
- NCT06556875
- Acronym / sponsor ID
- RHCIVFYWNWO
- Conditions
- Normal Weight Obesity
- Keywords
- isometric exercise training, high-intensity interval training, normal weight obesity, vascular fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 16 Aug 2024 (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.
Comparison of the effects of combined IET with HIIT and HIIT on vascular function in young NWO women.
Detailed description
This is a randomized clinical trial of single-blind with 3 arms (control group , HIIT group and IET with HIIT group), in which a pre-treatment-posttest design has been used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIIT group | Active comparator | Behavioral: HIIT |
| HIIT combined IET group | Active comparator | Behavioral: HIIT combined IET |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female, aged between 18 and 30 years old;
- BMI between 18.5 and 24.9 kg/m2 with a BF% > 30% (normal weight obesity determination criteria);
- exercise capacity to complete the exercise programme.
Key exclusion criteria (4 listed)
- Acute or chronic musculoskeletal disorders, cardiovascular diseases, etc. that prevented training;
- other diseases (such as diabetes, etc.) that had a great impact on physical condition;
- bad habits (such as smoking, drinking, etc.);
- and unstable body weight (up and down fluctuations of more than 2.5 kg) in the 3 months before the experiment.
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 |
|---|---|---|
| HIIThigh intensity interval training | Behavioural | HIIT group |
| HIIT combined IEThigh intensity interval training combined with isometric exercise training | Behavioural | HIIT combined IET group |
Primary outcome
Intima-Media Thickness (IMT)
Time frame: 8 weeks
The subjects were required to sit still for 5～10 minutes before the test, and the carotid artery structural and functional parameters were recorded using a GE vivid 7 colour ultrasound instrument from the United States as follows: the subjects were required to lie in the supine position, and the probe was used to sweep longitudinally along the outer edge of the sternocleidomastoid muscle, and the maximal Intima-media thickness (IMT) was measured. Changes in Intima media thickness before and after intervention.
Flow-Mediated Dilation (FMD)
Time frame: 8 weeks
Vascular endothelial function was measured with a Japanese-made UNEX EF vascular endothelial function tester. Pressure was applied on top of the resting blood pressure and the ischaemic process was performed for 5 min. At the end of the ischaemic process, the pressure band was removed and flow-mediated dilation (FMD) of the brachial artery was calculated. Changes in Flow-mediated dilation before and after Intervention
5 secondary outcomes
Body Composition Indicators
Time frame: 8 weeks
Body Mass Index (BMI)
Time frame: 8 weeks
Blood Pressure (BP)
Time frame: 8 weeks
Pulse Wave Velocity (PWV) and ankle brachial index (ABI)
Time frame: 8 weeks
Volume Oxygen Maximum (VO2max)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and HIIT combined IET in people with Normal Weight Obesity, run by Beijing Sport 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 4 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: finished, as of the sponsor's last update on 28 Oct 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intima-Media Thickness (IMT) (time frame: 8 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 28 Oct 2024.