NCT03700827

Brief Summary

Study the effects of different exercise modes on total and regional adiposity variation in subcutaneous and visceral adipose tissue (VAT and SAT). The investigators hypothesize that total abdominal will improve for all the exercise groups compared to the control group. When comparing intervention groups: 1) no differences on the degree of improvement in total abdominal fat depots (VAT and SAT) 2) different degree of change when comparing specific sections at VAT and SAT are expected.

Trial Health

57
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Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

October 4, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

September 5, 2018

Last Update Submit

September 27, 2021

Conditions

Keywords

Abdominal FatVisceral Adipose TissueSubcutaneous Adipose TissueExerciseIntervention

Outcome Measures

Primary Outcomes (1)

  • Changes in Visceral Abdominal Tissue (VAT)

    Changes in VAT will be measured using Magnetic Resonance Imaging

    2 assessment periods: at baseline and week 4

Secondary Outcomes (13)

  • Changes in Subcutaneous Abdominal Tissue (SAT)

    2 assessment periods: at baseline and week 4

  • Changes in Muscular Strength

    2 assessment periods: at baseline and week 4

  • Changes in Cardiorespiratory Function

    2 assessment periods: at baseline and week 4

  • Changes in fat mass (kg)

    2 assessment periods: at baseline and week 4

  • Changes in relative body fat (%BF)

    2 assessment periods: at baseline and week 4

  • +8 more secondary outcomes

Study Arms (3)

Resistance Training Group

EXPERIMENTAL

Resistance training will consist of 3 whole body circuits per week for 3 weeks lasting approximately 1 hour per session. All major muscle groups will be involved (leg press, bent-over-row, bench press, back squat, dumbbell jump squats, dead-lifts, and weighted abdominal crunches). Each participant will go through each circuit three times with 30 seconds between each exercise and 2 minutes between each set.

Other: Resistance Training

Aerobic Training Group

EXPERIMENTAL

Aerobic interval training will consist of 3 sessions/week for 3 weeks for approximately 45-50 minutes per session depending on exercise energy expenditure. There will be two periods of intervals. The first period will be 3 minutes of high-intensity activity and the second period will be reduced to moderate-intensity for 2 minutes. The speed/incline will change depending on the participants perception or Borg's rating of perceived exertion. Intensity will be measured using Lactate levels after each session.

Other: Aerobic Training

Control Group

NO INTERVENTION

The control group must attend sessions but will not exercise.

Interventions

High-intensity Resistance Training Group

Resistance Training Group

Aerobic Interval Training Group

Aerobic Training Group

Eligibility Criteria

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

You may qualify if:

  • kg/m2 BMI
  • White/Caucasian
  • Female
  • Sedentary

You may not qualify if:

  • Known cardiovascular, pulmonary, metabolic disease
  • Pregnant females
  • Any excluded criteria with MRI scans (i.e. certain metal implants, recent tattoos)
  • Diabetic
  • Hypertension
  • Cigarette smoking
  • MRI related contraindications (metal, no removable devices, etc.)

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

Obesity, AbdominalMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition 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 5, 2018

First Posted

October 9, 2018

Study Start

October 1, 2017

Primary Completion

April 1, 2020

Study Completion

May 1, 2020

Last Updated

October 4, 2021

Record last verified: 2021-03

Locations