Back to resultsOnsite vs. Virtual Group Fitness in Overweight/Obese Women
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIIT Exercise Training
Sponsored by
About this trial
This is an interventional supportive care trial for Overweight and Obesity focused on measuring Exercise Program
Eligibility Criteria
Inclusion Criteria:
- Premenopausal adult females over the age of 18 and under the age of 45 with a BMI greater than or equal to 25 and a waist circumference greater than or equal to 35 inches.
- No medical contraindications to participation in an exercise program including major medical illnesses (i.e. cardiovascular disease, stroke, cancer, etc.)
- Ability to provide informed consent
- Willingness and ability to participate in an interval training in-person group fitness exercise program 3x/week for 12 weeks
Exclusion Criteria:
- Adults unable to consent or mini-mental score less than 18.
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Post-menopausal women
- Do not speak English
- Prisoners
- Subjects on medicines (serum glucose, insulin, weight loss medicines, beta-blockers) and having any medical pre-conditions that would interfere with one's capacity to exercise.
- Answer "Yes" to any of the questions on the Pre-Activity Screening Questionnaire (PASQ)
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
In-person exercise training group
Virtual exercise training group
Arm Description
participants in this group will receive in person exercise HIIT training 3 days a week for 12 weeks
participants in this group will receive virtual exercise HIIT training 3 days a week for 12 weeks
Outcomes
Primary Outcome Measures
Pulse Wave Velocity (PWV)
vascular marker of cardiac risk will be reported as PWV (m/s) as measured using SphygmoCor
Pulse Wave Analysis Augmentation Index (AIx)
vascular marker of cardiac risk will be reported as AIx (%) as measured using SphygmoCor
Pulse Wave Analysis Mean Arterial Pressure (MAP)
vascular marker of cardiac risk will be reported as MAP (mmHg) as measured using SphygmoCor
Visceral Adipose Tissue (VAT) content
Anthropometric measure will be reported as VAT content as measured by noninvasive direct segmental multi-frequency bioelectrical impedance body composition analyzer
Total Adiposity
Anthropometric measure will be reported as Total Adiposity as measured by noninvasive direct segmental multi-frequency bioelectrical impedance body composition analyzer
Aerobic Fitness
Aerobic Fitness level as measured by the 20 meter shuttle run
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04974476
Brief Title
Onsite vs. Virtual Group Fitness in Overweight/Obese Women
Official Title
A Comparison of Onsite vs. Virtual Fitness Program on Anthropometric Measures, Aerobic Fitness, and Vascular Markers of Cardiac Risk Markers in Overweight/Obese Premenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 24, 2021 (Actual)
Primary Completion Date
November 8, 2021 (Actual)
Study Completion Date
November 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare an onsite to virtual whole-body high intensity interval training (HIIT) program on anthropometric variables, aerobic fitness measures, and vascular markers of cardiac risk in a single study of overweight and obese women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Exercise Program
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In-person exercise training group
Arm Type
Experimental
Arm Description
participants in this group will receive in person exercise HIIT training 3 days a week for 12 weeks
Arm Title
Virtual exercise training group
Arm Type
Experimental
Arm Description
participants in this group will receive virtual exercise HIIT training 3 days a week for 12 weeks
Intervention Type
Other
Intervention Name(s)
HIIT Exercise Training
Intervention Description
The HIIT total session duration will be approximately 30 minutes and will be composed of 10 sets of 60 seconds of high-intensity exercises, >80% of maximum heart rate (MHR), interspersed with a recovery period of 60 seconds of low-intensity exercise at 60% of MHR.
Primary Outcome Measure Information:
Title
Pulse Wave Velocity (PWV)
Description
vascular marker of cardiac risk will be reported as PWV (m/s) as measured using SphygmoCor
Time Frame
Up to 12 weeks
Title
Pulse Wave Analysis Augmentation Index (AIx)
Description
vascular marker of cardiac risk will be reported as AIx (%) as measured using SphygmoCor
Time Frame
Up to 12 weeks
Title
Pulse Wave Analysis Mean Arterial Pressure (MAP)
Description
vascular marker of cardiac risk will be reported as MAP (mmHg) as measured using SphygmoCor
Time Frame
Up to 12 weeks
Title
Visceral Adipose Tissue (VAT) content
Description
Anthropometric measure will be reported as VAT content as measured by noninvasive direct segmental multi-frequency bioelectrical impedance body composition analyzer
Time Frame
Up to 12 weeks
Title
Total Adiposity
Description
Anthropometric measure will be reported as Total Adiposity as measured by noninvasive direct segmental multi-frequency bioelectrical impedance body composition analyzer
Time Frame
Up to 12 weeks
Title
Aerobic Fitness
Description
Aerobic Fitness level as measured by the 20 meter shuttle run
Time Frame
Up to 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal adult females over the age of 18 and under the age of 45 with a BMI greater than or equal to 25 and a waist circumference greater than or equal to 35 inches.
No medical contraindications to participation in an exercise program including major medical illnesses (i.e. cardiovascular disease, stroke, cancer, etc.)
Ability to provide informed consent
Willingness and ability to participate in an interval training in-person group fitness exercise program 3x/week for 12 weeks
Exclusion Criteria:
Adults unable to consent or mini-mental score less than 18.
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Post-menopausal women
Do not speak English
Prisoners
Subjects on medicines (serum glucose, insulin, weight loss medicines, beta-blockers) and having any medical pre-conditions that would interfere with one's capacity to exercise.
Answer "Yes" to any of the questions on the Pre-Activity Screening Questionnaire (PASQ)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlette C Perry
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Onsite vs. Virtual Group Fitness in Overweight/Obese Women
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