Vascular DiseasesNCT05817487
Effects of COP Exercise and HIIT on Vascular Health in Young Overweight Females
A study testing high-intensity interval training (HIIT) and crossover point(COP) exercise training in people with Vascular Diseases, run by Beijing Sport University at 1 site in China.
Trial summary
The goal of this study is to determine the effects of high-intensity interval training and crossover point exercise training on vascular health in young overweight 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
- Vascular Diseases
- What is being tested?
- high-intensity interval training (HIIT) and crossover point(COP) exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2019to 25 Oct 2019
- 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, 18-30 years old
- Body mass index (BMI) < 28 kg/m2 and ≥ 24 kg/m2
- No exercise habit, and no recent new exercise plan
- No contraindications to exercise
Who cannot join
- Participates had an orthopedic or other condition that limited participation in daily exercise
- Participates had a history of myocardial infarction, stroke, diabetes mellitus, chronic respiratory disease or cancer
- Participates had smoking or alcohol behavior
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Crossover Point Exercise and High-intensity Interval Training on Vascular Health in Young Overweight Females
The goal of this study is to determine the effects of high-intensity interval training and crossover point exercise training on vascular health in young overweight women.
Read the detailed description
In recent years, improving cardiovascular health through exercise has become a popular research question, however, it is not clear which intensity and modes of exercise bring more benefits. Crossover point(COP) intensity has great medical potential as a personalized exercise intensity that is based on substrate utilization mode, especially in overweight and obese people.On the other hand, several studies have demonstrated that HIIT is an effective method in improving vascular endothelial dysfunction. During our study, we evaluated the vascular health changes in young overweight women who received either COP exercise or HIIT exercise for 10 weeks.
- Conditions
- Vascular Diseases
- Being tested
- high-intensity interval training (HIIT), crossover point(COP) exercise training
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity interval training (HIIT)Behavioural
Participants in both the COP and HIIT groups underwent 30 sessions of exercise performed over 10 weeks. The training sessions in the HIIT group involved five high-intensity intervals of 4 minutes each (running or walking on a treadmill) at 85% VO2max interspersed with 3 minutes of low-intensity walking.
crossover point(COP) exercise trainingBehavioural
Participants in both the COP and HIIT groups underwent 30 sessions of exercise performed over 10 weeks. The COP exercise training sessions involved 45 minutes of continuous exercise at the COP on a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| HIIT group | Experimental | Not described Receives: Behavioral: high-intensity interval training (HIIT) |
| COP group | Experimental | Not described Receives: Behavioral: crossover point(COP) exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
brachial-ankle pulse wave velocity (baPWV)
The change of baPWV before and after intervention
Measured: 10 weeks
blood pressure
The change of blood pressure before and after intervention
Measured: 10 weeks
Secondary outcomes (2)
Interleukin 6 (IL-6)
The change of IL-6 level before and after intervention
Measured: 10 weeks
Homocysteine (HCY)
The change of HCY level before and after intervention
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start18 Feb 2019
- Primary completion5 Jul 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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
- None (open label)
- Enrolment
- 20 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
- NCT05817487
- Sponsor's protocol ID
- EOCPEAHITOVHIYOF
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Crossover Point Exercise and High-intensity Interval Training on Vascular Health in Young Overweight Females
- ClinicalTrials.gov ID
- NCT05817487
- Acronym / sponsor ID
- EOCPEAHITOVHIYOF
- Conditions
- Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 18 Apr 2023 (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.
The goal of this study is to determine the effects of high-intensity interval training and crossover point exercise training on vascular health in young overweight women.
Detailed description
In recent years, improving cardiovascular health through exercise has become a popular research question, however, it is not clear which intensity and modes of exercise bring more benefits. Crossover point(COP) intensity has great medical potential as a personalized exercise intensity that is based on substrate utilization mode, especially in overweight and obese people.On the other hand, several studies have demonstrated that HIIT is an effective method in improving vascular endothelial dysfunction. During our study, we evaluated the vascular health changes in young overweight women who received either COP exercise or HIIT exercise for 10 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT group | Experimental | Behavioral: high-intensity interval training (HIIT) |
| COP group | Experimental | Behavioral: crossover point(COP) exercise training |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female, 18-30 years old
- Body mass index (BMI) < 28 kg/m2 and ≥ 24 kg/m2
- No exercise habit, and no recent new exercise plan
- No contraindications to exercise
Key exclusion criteria (3 listed)
- Participates had an orthopedic or other condition that limited participation in daily exercise
- Participates had a history of myocardial infarction, stroke, diabetes mellitus, chronic respiratory disease or cancer
- Participates had smoking or alcohol behavior
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 |
|---|---|---|
| high-intensity interval training (HIIT)Participants in both the COP and HIIT groups underwent 30 sessions of exercise performed over 10 weeks. The training sessions in the HIIT group involved five high-intensity intervals of 4 minutes each (running or walking on a treadmill) at 85% VO2max interspersed with 3 minutes of low-intensity walking. | Behavioural | HIIT group |
| crossover point(COP) exercise trainingParticipants in both the COP and HIIT groups underwent 30 sessions of exercise performed over 10 weeks. The COP exercise training sessions involved 45 minutes of continuous exercise at the COP on a treadmill. | Behavioural | COP group |
Primary outcome
brachial-ankle pulse wave velocity (baPWV)
Time frame: 10 weeks
The change of baPWV before and after intervention
blood pressure
Time frame: 10 weeks
The change of blood pressure before and after intervention
2 secondary outcomes
Interleukin 6 (IL-6)
Time frame: 10 weeks
Homocysteine (HCY)
Time frame: 10 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 18 Apr 2023.
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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 high-intensity interval training (HIIT) and crossover point(COP) exercise training in people with Vascular Diseases, 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 4 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: finished, as of the sponsor's last update on 18 Apr 2023. 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?
brachial-ankle pulse wave velocity (baPWV) (time frame: 10 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 18 Apr 2023.