ClinicalTrials.gg
TerminatedNCT03297333Updated Oct 4, 2021

Effects of Exercise Mode on Cardiac Fat and Function

An interventional study of Resistance training and Aerobic interval training in Obesity, sponsored by Southern Illinois University Edwardsville. Terminated at 1 site in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-04.

Sponsored by Southern Illinois University Edwardsville · Not applicable, Interventional, and Treatment

Why this study was terminated
Covid/19
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

Keywords

  • Obesity
  • Exercise
  • Cardiac Fat
  • Cardiac Magnetic Resonance
  • Vascular Health
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 18 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Southern Illinois University Edwardsville is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • 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.

    Other: Resistance training

  • 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).

    Other: Aerobic interval training

  • No intervention
    Control group

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

Interventions

  • OtherResistance training

    The resistance training group

  • OtherAerobic interval training

    The aerobic interval training group

06

What researchers measure

Primary outcomes

  1. Changes in Epicardial adipose tissue (EAT)

    EAT will be measured using cardiac Magnetic Resonance

    Time frame: 2 assessment points: at baseline and week 4

  2. Changes in Vascular Health

    Atrial stiffness will be measured using a pulse wave analysis

    Time frame: 2 assessment points: at baseline and week 4

Secondary outcomes

  1. Changes in Paracardial adipose tissue (PAT)

    PAT will be measured using cardiac Magnetic Resonance

    Time frame: 2 assessment points: at baseline and week 4

  2. Changes in Body Composition

    Body composition will be measured using dual-energy x-ray absorptiometry

    Time frame: 2 assessment points: at baseline and week 4

  3. Changes in Cardiorespiratory Function

    Cardiorespiratory Function will be measured on a treadmill with a metabolic cart

    Time frame: 2 assessment points: at baseline and week 4

  4. Changes in Muscular Strength

    Muscular Strength will be assessed by 1 repetition maximum (1RM) test

    Time frame: 2 assessment points: at baseline and week 4

07

Study locations

1 site
  • Southern Illinois University of Edwardsville
    Edwardsville, Illinois 62026, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in Mar 2020, 29 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2017
First posted
Sep 29, 2017
StartActual
Oct 1, 2017
Primary completionActual
Mar 16, 2020
CompletionActual
Mar 16, 2020
Last update
Oct 4, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03297333
Lead sponsor
Southern Illinois University Edwardsville
Responsible party
Sponsor
First posted
Sep 29, 2017
Start date
Oct 1, 2017
Primary completion
Mar 16, 2020
Completion
Mar 16, 2020
Last update
Oct 4, 2021

Study contacts

Maria Fernandez del Valle, PhD
principal investigator · Southern Illinois University of Edwardsville

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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