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Effect of Two Exercise Programs on Obese Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03980860
Recruitment Status : Active, not recruiting
First Posted : June 10, 2019
Last Update Posted : September 11, 2019
Information provided by (Responsible Party):
Adarsh Gupta, DO, MS, FACOFP, Rowan University

Brief Summary:
The purpose of the study is to compare the effectiveness of two exercise programs (High Intensity Interval Training/HIIT and Low Intensity (LIT) Long Duration training) on decreasing fat mass and preserving lean body mass in obese patients. What the investigators are proposing is that HIIT is less effective because it will most likely decrease lean body mass in obese patients, whereas LIT decreases fat mass and conserves lean body tissue.

Condition or disease Intervention/treatment Phase
Obesity Hypertension Other: Exercise Type Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This is a case/control study comparing overweight/obese patients of three different groups (control, HIIT, LIT). The goal of a case/control is to show whether exposure to HIIT, two times a week for 6 weeks will decrease lean body mass versus control and LIT. If it turns out that lean body mass does decrease, then HIIT is not an effective exercise modality for overweight/obese patients, and in fact LIT or control may be a better option.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of HIIT vs Low Intensity Training on Fat Loss in Obese Patients
Actual Study Start Date : June 5, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: HIIT (High Intensity Interval Training)
Subjects are undergoing high intensity interval training
Other: Exercise Type
The implementation of 2 types of exercise programs to reduce body fat

Active Comparator: Low intensity training long duration
Subjects are undergoing a lower intensity training program for a long duration
Other: Exercise Type
The implementation of 2 types of exercise programs to reduce body fat

No Intervention: Control
No exercise program intervention (usual care)

Primary Outcome Measures :
  1. Body fat [ Time Frame: 6 weeks ]
    Reduction in body fat

  2. Lean body mass [ Time Frame: 6 weeks ]
    Retention of lean body mass

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 6 weeks ]
    Reduction of blood pressure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Anyone with a BMI of 25 and above

Exclusion Criteria:

  • Those that cannot exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03980860

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United States, New Jersey
Rowan SOM Family Medicine
Stratford, New Jersey, United States, 08084
Sponsors and Collaborators
Rowan University
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Principal Investigator: Adarsh Gupta, DO Rowan University

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Responsible Party: Adarsh Gupta, DO, MS, FACOFP, Professor of Family Medicine, Rowan University Identifier: NCT03980860     History of Changes
Other Study ID Numbers: Pro2019000482
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases