Back to resultsEffects of Exercise on Cardiac Fat in Women With Obesity: a Pilot Study
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- BMI 30-39.99
- White/Caucasian
Exclusion Criteria:
- 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
- MRI exclusion criteria must be observed: must complete a safety checklist that is designed to identify metal in your body that could pose a hazard during scanning. Some forms of metal are acceptable (e.g., dental fillings after 1970). Tattoos are generally not exclusionary, unless they have been inked with metallic dyes. All metal must be removed from your body. All female subjects, prior to scanning, are required to complete a pregnancy test. Must NOT be claustrophobic or have a history of claustrophobia
Sites / Locations
- Kinesiology and Sport Management
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise Intervention
Control
Arm Description
Hight intensity resistance training group
No-exercise control group
Outcomes
Primary Outcome Measures
Changes in Cardiac fat volumes
Cardiac fat volumes will be assessed by means of Magnetic Resonance Imaging
Secondary Outcome Measures
Changes in Vascular function
Vascular function will be assessed by means of Arterial Tonometry
Changes in Cardiorespiratory Function
Cardiorespiratory Function will be assessed on a treadmill test with a 12-lead EKG. Protocol: Modified Bruce (A baseline stage will be added)
Changes in Muscular Strength
Muscular Strength in upper and lower extremities will be assessed by 1 repetition maximum (1RM) test on Bench Press and Leg Press
Changes in Body Composition
Body Composition will be assessed using Dual-energy x-ray absorptiometry
Changes in Diet
Diet will be assessed using the ASA24h recall (http://epi.grants.cancer.gov/asa24/)
Changes in Spontaneous Physical Activity
Spontaneous Physical Activity will be assessed using accelerometers Actical.
Changes in Oxidative stress markers
Blood will be collected and processed in order to assess oxidative stress markers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02589327
Brief Title
Effects of Exercise on Cardiac Fat in Women With Obesity: a Pilot Study
Official Title
Effects of Exercise on Cardiac Fat in Women With Obesity: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. More effective treatments are needed to induce changes in cardiac fat content, body composition, and cardiac fat metabolic activity that result in a reduction in cardiovascular risk in overweight and obese population. Despite this need, little is known about which mode, frequency, and duration of exercise will allow for greater reductions in cardiac fat, improvements in body composition, restoration of a healthy cardiac fat metabolic activity, and improvement on cardiovascular risk markers. The aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Intervention
Arm Type
Experimental
Arm Description
Hight intensity resistance training group
Arm Title
Control
Arm Type
No Intervention
Arm Description
No-exercise control group
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Cardiac fat volumes
Description
Cardiac fat volumes will be assessed by means of Magnetic Resonance Imaging
Time Frame
2 assessment points: at baseline and week 4
Secondary Outcome Measure Information:
Title
Changes in Vascular function
Description
Vascular function will be assessed by means of Arterial Tonometry
Time Frame
2 assessment points: at baseline and week 4
Title
Changes in Cardiorespiratory Function
Description
Cardiorespiratory Function will be assessed on a treadmill test with a 12-lead EKG. Protocol: Modified Bruce (A baseline stage will be added)
Time Frame
2 assessment points: at baseline and week 4
Title
Changes in Muscular Strength
Description
Muscular Strength in upper and lower extremities will be assessed by 1 repetition maximum (1RM) test on Bench Press and Leg Press
Time Frame
2 assessment points: at baseline and week 4
Title
Changes in Body Composition
Description
Body Composition will be assessed using Dual-energy x-ray absorptiometry
Time Frame
2 assessment points: at baseline and week 4
Title
Changes in Diet
Description
Diet will be assessed using the ASA24h recall (http://epi.grants.cancer.gov/asa24/)
Time Frame
5 assessment points: baseline, week 1, 2, 3, and 4
Title
Changes in Spontaneous Physical Activity
Description
Spontaneous Physical Activity will be assessed using accelerometers Actical.
Time Frame
Baseline and week 4
Title
Changes in Oxidative stress markers
Description
Blood will be collected and processed in order to assess oxidative stress markers
Time Frame
5 assessment points: pre-post during session 1, pre-post during session 9, and pre week 4.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI 30-39.99
White/Caucasian
Exclusion Criteria:
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
MRI exclusion criteria must be observed: must complete a safety checklist that is designed to identify metal in your body that could pose a hazard during scanning. Some forms of metal are acceptable (e.g., dental fillings after 1970). Tattoos are generally not exclusionary, unless they have been inked with metallic dyes. All metal must be removed from your body. All female subjects, prior to scanning, are required to complete a pregnancy test. Must NOT be claustrophobic or have a history of claustrophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Fernandez del Valle, PhD
Organizational Affiliation
Texas Tech University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kinesiology and Sport Management
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79423
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Exercise on Cardiac Fat in Women With Obesity: a Pilot Study
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