NCT03297333

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

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

September 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

October 4, 2021

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

September 26, 2017

Last Update Submit

September 27, 2021

Conditions

Keywords

ObesityExerciseCardiac FatCardiac Magnetic ResonanceVascular Health

Outcome Measures

Primary Outcomes (2)

  • Changes in Epicardial adipose tissue (EAT)

    EAT will be measured using cardiac Magnetic Resonance

    2 assessment points: at baseline and week 4

  • Changes in Vascular Health

    Atrial stiffness will be measured using a pulse wave analysis

    2 assessment points: at baseline and week 4

Secondary Outcomes (4)

  • Changes in Paracardial adipose tissue (PAT)

    2 assessment points: at baseline and week 4

  • Changes in Body Composition

    2 assessment points: at baseline and week 4

  • Changes in Cardiorespiratory Function

    2 assessment points: at baseline and week 4

  • Changes in Muscular Strength

    2 assessment points: at baseline and week 4

Study Arms (3)

Resistance training group

EXPERIMENTAL

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

Aerobic interval training group

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. 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

Control group

NO INTERVENTION

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

Interventions

The resistance training group

Resistance training group

The aerobic interval training group

Aerobic interval training group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Illinois University of Edwardsville

Edwardsville, Illinois, 62026, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maria Fernandez del Valle, PhD

    Southern Illinois University of Edwardsville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

September 29, 2017

Study Start

October 1, 2017

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

October 4, 2021

Record last verified: 2019-07

Locations