Effects of a Short-term Aerobic Interval Exercise Program on Cardiac Fat and Function in Women With Obesity: A Pilot Study

September 20, 2021 updated by: Maria Fernandez Del Valle, Southern Illinois University Edwardsville
The overall goal of this project is to the study the effects of an aerobic interval training program on cardiac fat, and its relationship to cardiac function using cardiac Magnetic Resonance Imaging.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • United States
    • Illinois
      • Edwardsville, Illinois, United States, 62026
        • Southern Illinois University Edwardsville

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • females, age 18-40 years old, body mass index (BMI) ≥ 30 kg/m2 and < 39.9 kg/m2, without known metabolic and/or cardiovascular disease

Exclusion Criteria:

  • known CV, metabolic or pulmonary diseases or conditions, muscular-skeletal injuries (i.e. spine, knees, hips or shoulders, taking medications that affect endocrine or cardiovascular function, hypertension, being engaged in moderate intensity exercise more than two times per week or moderate-high intensity training of any type and frequency, being pregnant, cigarette smoking, having non-removable pieces or devices incompatible with DXA and CMR assessment

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic interval
Aerobic interval will consist of a supervised aerobic interval training sessions 3 times/week. Duration will range between 45-50 min/session depending on the exercise energy expenditure (target expenditure ~450-500kcal/session). Each interval will have a total duration of 5 min, and it will be divided into 2 periods. The first period will consist of 3 minutes of high-intensity activity at 70-85% of predicted HRmax, and for the second period the intensity will be reduced to 60-65% of predicted HRmax for 2 minutes. The training sessions will be carried out outdoors at the trails located on campus. The activity will consist of walking and/or light jogging. The speed/incline will be changed depending on the participants' heart rate and perception using the Borg's rating of perceived exertion (RPE) as needed. The RPE for the first period range will be 13-17 (15-17 at the end of the period) and 10-12 for the second period.
Other: Aerobic Interval Training
The aerobic interval training group
No Intervention: Control group
Participants in the control group will not participate in the training programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Cardiac Adipose Tissue (CAT)
Time Frame: 2 assessment points: at baseline and week 5
CAT will be measured using cardiac Magnetic Resonance
2 assessment points: at baseline and week 5
Changes in Cardiac Function
Time Frame: 2 assessment points: at baseline and week 5
Cardiac Function will be measured using cardiac Magnetic Resonance
2 assessment points: at baseline and week 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Body Composition
Time Frame: 2 assessment points: at baseline and week 5
Body composition will be measured using dual-energy x-ray absorptiometry
2 assessment points: at baseline and week 5
Changes in Cardiorespiratory Function
Time Frame: 2 assessment points: at baseline and week 5
Cardiorespiratory Function will be measured on a treadmill with a metabolic cart
2 assessment points: at baseline and week 5
Changes in Muscular Strength
Time Frame: 2 assessment points: at baseline and week 5
Muscular Strength will be assessed through 1 repetition maximum (1RM).
2 assessment points: at baseline and week 5
Changes in Blood Pressure
Time Frame: 2 assessment points: at baseline and week 5
Blood pressure will be measured using pulse wave analysis
2 assessment points: at baseline and week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Illinois University Edwardsville

Investigators

  • Principal Investigator: Maria Fernandez del Valle, PhD, Southern Illinois University of Edwardsville

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)

March 16, 2021

Primary Completion (Actual)

April 16, 2021

Study Completion (Actual)

April 16, 2021

Study Registration Dates

First Submitted

March 13, 2021

First Submitted That Met QC Criteria

March 13, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1063

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

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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