- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02589327
Effects of Exercise on Cardiac Fat in Women With Obesity: a Pilot Study
May 9, 2016 updated by: Texas Tech University
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Lubbock, Texas, United States, 79423
- Kinesiology and Sport Management
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise Intervention
Hight intensity resistance training group
|
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.
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No Intervention: Control
No-exercise control group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Cardiac fat volumes
Time Frame: 2 assessment points: at baseline and week 4
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Cardiac fat volumes will be assessed by means of Magnetic Resonance Imaging
|
2 assessment points: at baseline and week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Vascular function
Time Frame: 2 assessment points: at baseline and week 4
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Vascular function will be assessed by means of Arterial Tonometry
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2 assessment points: at baseline and week 4
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Changes in Cardiorespiratory Function
Time Frame: 2 assessment points: at baseline and week 4
|
Cardiorespiratory Function will be assessed on a treadmill test with a 12-lead EKG.
Protocol: Modified Bruce (A baseline stage will be added)
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2 assessment points: at baseline and week 4
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Changes in Muscular Strength
Time Frame: 2 assessment points: at baseline and week 4
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Muscular Strength in upper and lower extremities will be assessed by 1 repetition maximum (1RM) test on Bench Press and Leg Press
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2 assessment points: at baseline and week 4
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Changes in Body Composition
Time Frame: 2 assessment points: at baseline and week 4
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Body Composition will be assessed using Dual-energy x-ray absorptiometry
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2 assessment points: at baseline and week 4
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Changes in Diet
Time Frame: 5 assessment points: baseline, week 1, 2, 3, and 4
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Diet will be assessed using the ASA24h recall (http://epi.grants.cancer.gov/asa24/)
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5 assessment points: baseline, week 1, 2, 3, and 4
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Changes in Spontaneous Physical Activity
Time Frame: Baseline and week 4
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Spontaneous Physical Activity will be assessed using accelerometers Actical.
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Baseline and week 4
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Changes in Oxidative stress markers
Time Frame: 5 assessment points: pre-post during session 1, pre-post during session 9, and pre week 4.
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Blood will be collected and processed in order to assess oxidative stress markers
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5 assessment points: pre-post during session 1, pre-post during session 9, and pre week 4.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria Fernandez del Valle, PhD, Texas Tech University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
October 14, 2015
First Submitted That Met QC Criteria
October 27, 2015
First Posted (Estimate)
October 28, 2015
Study Record Updates
Last Update Posted (Estimate)
May 11, 2016
Last Update Submitted That Met QC Criteria
May 9, 2016
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 504792C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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