NCT02589327

Brief Summary

Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. The aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 11, 2016

Status Verified

September 1, 2015

Enrollment Period

7 months

First QC Date

October 14, 2015

Last Update Submit

May 9, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in Cardiac fat volumes

    Cardiac fat volumes will be assessed by means of Magnetic Resonance Imaging

    2 assessment points: at baseline and week 4

Secondary Outcomes (7)

  • Changes in Vascular function

    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

  • Changes in Body Composition

    2 assessment points: at baseline and week 4

  • Changes in Diet

    5 assessment points: baseline, week 1, 2, 3, and 4

  • +2 more secondary outcomes

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

Hight intensity resistance training group

Other: Exercise Intervention

Control

NO INTERVENTION

No-exercise control group

Interventions

The intervention will consist of 3 weeks of whole body circuit training (resistance training) where participants in the intervention group will perform 7 different exercises. The circuit will consist of 10 repetitions per exercise of 7 exercises: leg press, bent-over row, bench press, squats, dumbbell jump squats with raises, dead-lifts and weighted abdominal crunches, with approximately 30 sec of rest in between each exercise (based on the estimated time needed to move from one position to the next). Each participant will move through the circuit 3 times, with 2 to 3 minutes of rest between each round. Intensity will be 6-7 of RPE at the first set, and 9-10 at the third set.

Exercise Intervention

Eligibility Criteria

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

You may qualify if:

  • BMI 30-39.99
  • White/Caucasian

You may not qualify if:

  • Known health problems such as cardiovascular, pulmonary or metabolic disease will be excluded.
  • Pregnant females.
  • Any adults found taking medications that affect endocrine or cardiovascular function will also be excluded from the study.
  • Participants that exercise more than three times per week or strength train more than twice per week.
  • Individuals that have poor venous access or have expressed a fear of needles or having blood taken will also be excluded.
  • Cigarette smoking (current or those who quit within the previous 6 months
  • Hypertension
  • Diabetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kinesiology and Sport Management

Lubbock, Texas, 79423, 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

    Texas Tech University

    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

October 14, 2015

First Posted

October 28, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 11, 2016

Record last verified: 2015-09

Locations