- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03297333
Effects of Exercise Mode on Cardiac Fat and Function
September 27, 2021 updated by: Southern Illinois University Edwardsville
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
18
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
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Illinois
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Edwardsville, Illinois, United States, 62026
- Southern Illinois University of Edwardsville
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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 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
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 |
|---|---|
|
No Intervention: Control group
Participants in the control group will not participate in the training programs.
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Experimental: Resistance training group
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.
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The resistance training group
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Experimental: Aerobic interval training group
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).
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The aerobic interval training group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Epicardial adipose tissue (EAT)
Time Frame: 2 assessment points: at baseline and week 4
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EAT will be measured using cardiac Magnetic Resonance
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2 assessment points: at baseline and week 4
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Changes in Vascular Health
Time Frame: 2 assessment points: at baseline and week 4
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Atrial stiffness will be measured using a pulse wave analysis
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2 assessment points: at baseline and week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Paracardial adipose tissue (PAT)
Time Frame: 2 assessment points: at baseline and week 4
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PAT will be measured using cardiac Magnetic Resonance
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2 assessment points: at baseline and week 4
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Changes in Body Composition
Time Frame: 2 assessment points: at baseline and week 4
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Body composition will be measured using dual-energy x-ray absorptiometry
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2 assessment points: at baseline and week 4
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Changes in Cardiorespiratory Function
Time Frame: 2 assessment points: at baseline and week 4
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Cardiorespiratory Function will be measured on a treadmill with a metabolic cart
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2 assessment points: at baseline and week 4
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Changes in Muscular Strength
Time Frame: 2 assessment points: at baseline and week 4
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Muscular Strength will be assessed by 1 repetition maximum (1RM) test
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2 assessment points: at baseline and week 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 1, 2017
Primary Completion (Actual)
March 16, 2020
Study Completion (Actual)
March 16, 2020
Study Registration Dates
First Submitted
September 26, 2017
First Submitted That Met QC Criteria
September 28, 2017
First Posted (Actual)
September 29, 2017
Study Record Updates
Last Update Posted (Actual)
October 4, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-1208-4C-1
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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