High-intensity Interval Training in Overweight/Obese
Primary Purpose
Obesity, Metabolically Benign
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interval training
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Metabolically Benign
Eligibility Criteria
Inclusion Criteria:
- written and dated informed consent to participate in the study.
- willing and able to comply with the protocol.
- good health as determined by a health and exercise status questionnaire
- normal electrocardiogram (ECG), and physical.
- body mass index of 25-45 kg/m 2.
- has been cleared for participation by a physician (either study or personal).
Exclusion Criteria:
- participating in another clinical trial or have received an investigational product within thirty days prior to enrollment.
- has lost ten or more pounds during the previous three months and maintained the weight loss.
- significant history or current presence of untreated high blood pressure (BP) [systolic BP> 140 mmHg and/or diastolic BP> 90 mmHg], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. Subject currently suffers from/or has a known history of (or is currently being treated for) clinical depression or an eating disorder(s).
- has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
- are identified as moderate to high risk individuals by the American College of Sports Medicine will be excluded from the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
High-intensity interval -2min
High-intensity interval -1min
Control
Arm Description
5 bouts of 2 min cycling at varying intensities of VO2peak (80-100%) with 1 min recovery.
10 bouts of 1 min cycling at 90% of VO2peak with 1 min rest periods
No exercise
Outcomes
Primary Outcome Measures
Cardiorespiratory Fitness (VO2peak)
Secondary Outcome Measures
Body Composition
Blood Lipids
Full Information
NCT ID
NCT02444377
First Posted
May 11, 2015
Last Updated
November 29, 2016
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT02444377
Brief Title
High-intensity Interval Training in Overweight/Obese
Official Title
Impact of Varying High-intensity Interval Protocols on Cardiometabolic Risk Factors in Overweight/Obese
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Purpose: The purpose of this study would be to evaluate the effects of interval training on cardiovascular health, lipid profile and body composition in overweight and obese men and women.
A secondary purpose will be to compare lab based measurements of body composition [4-compartment model (4C)) with portable equipment [bioelectrical impedance spectroscopy (BIS) and ultrasound (US)]
Participants: Seventy-six men and women (age 18-55 yrs; BMI 25-45 kg/m2) will be randomly assigned to a high-intensity short interval group (SIT), high-intensity long interval group (HIT) or a control group (CON). Procedures (methods): Participants will be assessed for peak oxygen utilization (VO2peak), blood lipids, glucose and insulin levels. Body composition will also be measured using a 4C model, as measured from dual energy x-ray absorptiometry (DEXA), air displacement plethysmography (BodPod), and BIS, in comparison to US values. Participants assigned to either training group will undergo 3 weeks of interval training, 3 days per week. SIT will complete 10 bouts of a series of 1 min cycling with 1 min rest periods at 90% of the power output obtained during VO2peak;in comparison HIT will complete 5 bouts of the same protocol: 2 min bouts with 1 min recovery at varying intensities of VO2peak (80-100% power output).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolically Benign
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-intensity interval -2min
Arm Type
Experimental
Arm Description
5 bouts of 2 min cycling at varying intensities of VO2peak (80-100%) with 1 min recovery.
Arm Title
High-intensity interval -1min
Arm Type
Experimental
Arm Description
10 bouts of 1 min cycling at 90% of VO2peak with 1 min rest periods
Arm Title
Control
Arm Type
No Intervention
Arm Description
No exercise
Intervention Type
Behavioral
Intervention Name(s)
Interval training
Primary Outcome Measure Information:
Title
Cardiorespiratory Fitness (VO2peak)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Body Composition
Time Frame
3 weeks
Title
Blood Lipids
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
written and dated informed consent to participate in the study.
willing and able to comply with the protocol.
good health as determined by a health and exercise status questionnaire
normal electrocardiogram (ECG), and physical.
body mass index of 25-45 kg/m 2.
has been cleared for participation by a physician (either study or personal).
Exclusion Criteria:
participating in another clinical trial or have received an investigational product within thirty days prior to enrollment.
has lost ten or more pounds during the previous three months and maintained the weight loss.
significant history or current presence of untreated high blood pressure (BP) [systolic BP> 140 mmHg and/or diastolic BP> 90 mmHg], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. Subject currently suffers from/or has a known history of (or is currently being treated for) clinical depression or an eating disorder(s).
has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
are identified as moderate to high risk individuals by the American College of Sports Medicine will be excluded from the study.
12. IPD Sharing Statement
Learn more about this trial
High-intensity Interval Training in Overweight/Obese
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