search
Back to results

Effects of Exercise Mode on Cardiac Fat and Function

Primary Purpose

Obesity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance training
Aerobic interval training
Sponsored by
Southern Illinois University Edwardsville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Exercise, Cardiac Fat, Cardiac Magnetic Resonance, Vascular Health

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Sedentary
  • Caucasian
  • BMI >30 kg/m2 and < 39.9 kg/m2

Exclusion Criteria:

  • Known cardiovascular, metabolic, pulmonary disease or conditions
  • Muscular-skeletal injuries
  • Taking medications that affect endocrine or cardiovascular function
  • Hypertension
  • Being engaged in low intensity strength training more than two times per week or moderate-high intensity of any type of frequency
  • Being pregnant
  • Cigarette smoking
  • Having non-removable pieces or devices incompatible with DXA and CMR assessment.

Sites / Locations

  • Southern Illinois University of Edwardsville

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Resistance training group

Aerobic interval training group

Control group

Arm Description

Resistance training will consist of a supervised circuit training 3 sessions/week for approximately 45-50 min/session. The circuit will include 7 strength exercises engaging the major muscle groups (leg press, rows, back squats, weighted crunches, deadlifts, bench press, and squat jumps with weights). The participants will perform 3 sets of 10 repetitions with resting periods of 30 seconds between exercises, and 2 minutes between sets. The overall OMNI-Resistance Exercise Scale per set will range between 8-10. Heart rate and exercise energy expenditure during the workout will be monitored. The load will be changed depending on the participants' perception when needed. In addition, the intensity will be monitored assessing Lactate concentrations at baseline and at the end of each session. Circuit will be repeated until meeting the targeted exercise energy expenditure of 450-500 kcal/session.

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. 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, and the second period the intensity will be reduced for 2 minutes. The speed/incline will be changed depending on the participants' heart rate and perception using the Borg's rating of perceived exertion as needed. Heart rate and exercise energy expenditure during the workout will be monitored. Intensity will be monitored assessing Lactate concentrations at the end of each session. Intervals will be repeated until meeting the targeted exercise energy expenditure (450-500 kcal/session).

Participants in the control group will not participate in the training programs.

Outcomes

Primary Outcome Measures

Changes in Epicardial adipose tissue (EAT)
EAT will be measured using cardiac Magnetic Resonance
Changes in Vascular Health
Atrial stiffness will be measured using a pulse wave analysis

Secondary Outcome Measures

Changes in Paracardial adipose tissue (PAT)
PAT will be measured using cardiac Magnetic Resonance
Changes in Body Composition
Body composition will be measured using dual-energy x-ray absorptiometry
Changes in Cardiorespiratory Function
Cardiorespiratory Function will be measured on a treadmill with a metabolic cart
Changes in Muscular Strength
Muscular Strength will be assessed by 1 repetition maximum (1RM) test

Full Information

First Posted
September 26, 2017
Last Updated
September 27, 2021
Sponsor
Southern Illinois University Edwardsville
search

1. Study Identification

Unique Protocol Identification Number
NCT03297333
Brief Title
Effects of Exercise Mode on Cardiac Fat and Function
Official Title
Effects of Exercise Mode on Cardiac Fat and Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Covid/19
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
March 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern Illinois University Edwardsville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall goal of this project is to study the effects of exercise energy expenditure matched vigorous dynamic resistance training and aerobic training on cardiac fat, and its relationship to cardiac function and geometry using cardiac Magnetic Resonance Imaging.
Detailed Description
Exercise-induced weight-loss is one of the most common strategies for reducing excess fat in overweight and obese individuals. Although vigorous intensity may be more favorable promoting positive cardiac adaptations compared to low-moderate intensity, evidence of the positive effects of different exercise modes needs to be explored to allow for realistic comparisons with other strategies. Research using cardiac Magnetic Resonance Imaging that compares the effects of different modes of exercise - matched by exercise energy expenditure - on epicardial adipose tissue and paracardial adipose tissue, and how these interventions modify cardiac function and geometry have not been previously explored in obesity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Exercise, Cardiac Fat, Cardiac Magnetic Resonance, Vascular Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance training group
Arm Type
Experimental
Arm Description
Resistance training will consist of a supervised circuit training 3 sessions/week for approximately 45-50 min/session. The circuit will include 7 strength exercises engaging the major muscle groups (leg press, rows, back squats, weighted crunches, deadlifts, bench press, and squat jumps with weights). The participants will perform 3 sets of 10 repetitions with resting periods of 30 seconds between exercises, and 2 minutes between sets. The overall OMNI-Resistance Exercise Scale per set will range between 8-10. Heart rate and exercise energy expenditure during the workout will be monitored. The load will be changed depending on the participants' perception when needed. In addition, the intensity will be monitored assessing Lactate concentrations at baseline and at the end of each session. Circuit will be repeated until meeting the targeted exercise energy expenditure of 450-500 kcal/session.
Arm Title
Aerobic interval training group
Arm Type
Experimental
Arm Description
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. 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, and the second period the intensity will be reduced for 2 minutes. The speed/incline will be changed depending on the participants' heart rate and perception using the Borg's rating of perceived exertion as needed. Heart rate and exercise energy expenditure during the workout will be monitored. Intensity will be monitored assessing Lactate concentrations at the end of each session. Intervals will be repeated until meeting the targeted exercise energy expenditure (450-500 kcal/session).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will not participate in the training programs.
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
The resistance training group
Intervention Type
Other
Intervention Name(s)
Aerobic interval training
Intervention Description
The aerobic interval training group
Primary Outcome Measure Information:
Title
Changes in Epicardial adipose tissue (EAT)
Description
EAT will be measured using cardiac Magnetic Resonance
Time Frame
2 assessment points: at baseline and week 4
Title
Changes in Vascular Health
Description
Atrial stiffness will be measured using a pulse wave analysis
Time Frame
2 assessment points: at baseline and week 4
Secondary Outcome Measure Information:
Title
Changes in Paracardial adipose tissue (PAT)
Description
PAT will be measured using cardiac Magnetic Resonance
Time Frame
2 assessment points: at baseline and week 4
Title
Changes in Body Composition
Description
Body composition will be measured using dual-energy x-ray absorptiometry
Time Frame
2 assessment points: at baseline and week 4
Title
Changes in Cardiorespiratory Function
Description
Cardiorespiratory Function will be measured on a treadmill with a metabolic cart
Time Frame
2 assessment points: at baseline and week 4
Title
Changes in Muscular Strength
Description
Muscular Strength will be assessed by 1 repetition maximum (1RM) test
Time Frame
2 assessment points: at baseline and week 4

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sedentary Caucasian BMI >30 kg/m2 and < 39.9 kg/m2 Exclusion Criteria: Known cardiovascular, metabolic, pulmonary disease or conditions Muscular-skeletal injuries Taking medications that affect endocrine or cardiovascular function Hypertension Being engaged in low intensity strength training more than two times per week or moderate-high intensity of any type of frequency Being pregnant Cigarette smoking Having non-removable pieces or devices incompatible with DXA and CMR assessment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Fernandez del Valle, PhD
Organizational Affiliation
Southern Illinois University of Edwardsville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Illinois University of Edwardsville
City
Edwardsville
State/Province
Illinois
ZIP/Postal Code
62026
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Exercise Mode on Cardiac Fat and Function

We'll reach out to this number within 24 hrs