- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06664281
Effects of SIT Combined with Remote Ischemic Preconditioning on Vascular Function in Young Women with Masked Obesity
October 28, 2024 updated by: Beijing Sport University
Effects of Sprint Interval Training Combined with Remote Ischemic Preconditioning on Vascular Function in Young Women with Masked Obesity
Comparison of the effects of combined Sprint Interval Training (SIT) with Remote Ischemic Preconditioning (RIPC) and SIT on vascular function in young women with masked obesity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized clinical trial of single-blind with 3 arms (control group, SIT group and SIT with RIPC group), in which a pre-treatment-posttest design has been used.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- School of Sports Medicine and Rehabilitation, Beijing Sport University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Females aged between 18 and 30 years;
- BMI within the normal range (18.5~24.9 kg/m²), BF% > 30%;
- Participants with no clinically diagnosed contraindications for exercise, in good health, and not engaged in regular exercise, as determined by the health and physical activity questionnaire (based on the American College of Sports Medicine's guidelines for exercise testing and prescription).
Exclusion Criteria:
- History of cardiovascular diseases, including coronary heart disease, stroke, or peripheral arterial disease diagnosed through vascular imaging techniques;
- Currently participating in other intervention studies, including dietary, nutritional, or psychological education programs;
- Those with regular professional training;
- Musculoskeletal disorders that make long-term exercise interventions unsuitable.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Active Comparator: sprint interval training group
|
sprint interval training
|
|
Active Comparator: sprint interval training combined with remote ischemic preconditioning group
|
sprint interval training combined with remote ischemic preconditioning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intima-Media Thickness (IMT)
Time Frame: 8 weeks
|
Changes in Intima media thickness before and after intervention.
|
8 weeks
|
|
Flow-Mediated Dilation (FMD)
Time Frame: 8 weeks
|
Changes in Flow-mediated dilation before and after Intervention.
Brachial artery flow-mediated dilation (FMD) was measured by the UNEXEF high-resolution ultrasound vascular endothelial function analyzer.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Composition Indicator
Time Frame: 8 weeks
|
Changes in Body composition indicators before and after Intervention.
Including body fat percentage (BF%).
|
8 weeks
|
|
Human Morphometric i Indicators
Time Frame: 8 weeks
|
Changes in Human morphometric indicators before and after Intervention.
Including height, weight, waist circumference, hip circumference, and body mass index (BMI).
BMI was calculated based on the measured height and weight using the formula: BMI = weight/height² (kg/m²).
|
8 weeks
|
|
Blood Pressure (BP)
Time Frame: 8 weeks
|
Changes in blood pressure before and after intervention.
Including systolic and diastolic blood pressure.
|
8 weeks
|
|
Nitric Oxide (NO)
Time Frame: 8 weeks
|
Changes in concentration of nitric oxide before and after Intervention.
|
8 weeks
|
|
Maximum Oxygen Uptake (VO2max)
Time Frame: 8 weeks
|
Changes in maximum oxygen uptake before and after Intervention.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2023
Primary Completion (Actual)
October 30, 2023
Study Completion (Actual)
December 30, 2023
Study Registration Dates
First Submitted
October 24, 2024
First Submitted That Met QC Criteria
October 28, 2024
First Posted (Actual)
October 29, 2024
Study Record Updates
Last Update Posted (Actual)
October 29, 2024
Last Update Submitted That Met QC Criteria
October 28, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESITCRIPVFYWMO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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