Onsite vs. Virtual Group Fitness in Overweight/Obese Women

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04974476
• Other study ID #: 20210038
• Status: Completed
• Phase: N/A
• Start date: July 24, 2021
• Est. completion date: November 8, 2021

Study information

• Verified date: November 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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)

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• HIIT Exercise Training
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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse Wave Velocity (PWV)	vascular marker of cardiac risk will be reported as PWV (m/s) as measured using SphygmoCor	Up to 12 weeks
Primary	Pulse Wave Analysis Augmentation Index (AIx)	vascular marker of cardiac risk will be reported as AIx (%) as measured using SphygmoCor	Up to 12 weeks
Primary	Pulse Wave Analysis Mean Arterial Pressure (MAP)	vascular marker of cardiac risk will be reported as MAP (mmHg) as measured using SphygmoCor	Up to 12 weeks
Primary	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	Up to 12 weeks
Primary	Total Adiposity	Anthropometric measure will be reported as Total Adiposity as measured by noninvasive direct segmental multi-frequency bioelectrical impedance body composition analyzer	Up to 12 weeks
Primary	Aerobic Fitness	Aerobic Fitness level as measured by the 20 meter shuttle run	Up to 12 weeks