Onsite vs. Virtual Group Fitness in Overweight/Obese Women

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: HIIT Exercise Training

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33134
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In-person exercise training group; participants in this group will receive in person exercise HIIT training 3 days a week for 12 weeks	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.
Experimental: Virtual exercise training group; participants in this group will receive virtual exercise HIIT training 3 days a week for 12 weeks	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse Wave Velocity (PWV)	vascular marker of cardiac risk will be reported as PWV (m/s) as measured using SphygmoCor	Up to 12 weeks
Pulse Wave Analysis Augmentation Index (AIx)	vascular marker of cardiac risk will be reported as AIx (%) as measured using SphygmoCor	Up to 12 weeks
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
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
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
Aerobic Fitness	Aerobic Fitness level as measured by the 20 meter shuttle run	Up to 12 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Arlette C Perry, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2021
• Primary Completion (Actual): November 8, 2021
• Study Completion (Actual): November 8, 2021

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Exercise Program
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 20210038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No