NCT04802005

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

March 13, 2021

Last Update Submit

September 20, 2021

Conditions

Keywords

Cardiac fatCardiac functionAerobic interval trainingCardiac Magnetic ResonanceVascular health

Outcome Measures

Primary Outcomes (2)

  • Changes in Cardiac Adipose Tissue (CAT)

    CAT will be measured using cardiac Magnetic Resonance

    2 assessment points: at baseline and week 5

  • Changes in Cardiac Function

    Cardiac Function will be measured using cardiac Magnetic Resonance

    2 assessment points: at baseline and week 5

Secondary Outcomes (4)

  • Changes in Body Composition

    2 assessment points: at baseline and week 5

  • Changes in Cardiorespiratory Function

    2 assessment points: at baseline and week 5

  • Changes in Muscular Strength

    2 assessment points: at baseline and week 5

  • Changes in Blood Pressure

    2 assessment points: at baseline and week 5

Study Arms (2)

Aerobic interval

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

The aerobic interval training group

Aerobic interval

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Illinois University Edwardsville

Edwardsville, Illinois, 62026, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Fernandez Del Valle, PhD

    Southern Illinois University of Edwardsville

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2021

First Posted

March 17, 2021

Study Start

March 16, 2021

Primary Completion

April 16, 2021

Study Completion

April 16, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations