- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03524521
Body Weight-Based Interval Training in Sedentary Overweight and Obese Adults
The Effect of Interval Training Using Body Weight on Body Composition in Sedentary Overweight and Obese Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
Participants will be randomly assigned to one of the two home-based exercise groups.
The MICT group is the standard care group and will be instructed to walk for 30 minutes, 5 days per week at a moderate intensity. The goal is to accumulate 150 minutes of continuous aerobic exercise each week. Participants will be instructed on the use of the Rating of Perceived Exertion (RPE) scale during baseline testing and will be instructed to reach an RPE of 12-16. A heart rate monitor will be worn to monitor exercise intensity. Heart rate should reach ~70% of maximal heart rate.
The IT group will perform 5 body-weight exercises in three progressive phases. During the first 2 weeks the circuit will be completed twice, 30 second intervals, 90 seconds of rest. The exercises will be performed on 3 days of the week with at least one day of rest between exercise days (ideally Monday, Wednesday, Friday). The number of repetitions will increase to a maximum of 4 while the interval and rest periods increase to a maximum of 45 seconds each. The total time spent performing intervals by week 8 will be 15 minutes. A 2 minute warm up and 3 minute cool down will be performed, such as jumping jacks or simply walking. A heart rate monitor will be used to measure exercise intensity. Heart rate should reach approximately 90% of heart rate max during the intervals. Participants will be instructed on the use of the Rating of Perceived Exertion scale during baseline testing and will be instructed to reach an RPE of ≥17 during the high intensity intervals.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults 18-65 years of age
- Willing and able to provide informed consent
- Sedentary, overweight and obese adults (<90 minutes of moderate intensity exercise)
- BMI 25≤35
- Able to safely begin an exercise program
- Have a smartphone, and willing and able to download and use the Fitbit app
Exclusion Criteria:
- Unable to provide informed consent.
- Known cardiovascular disease, or uncontrolled hypertension,
- Diagnosed type 1 or 2 diabetes
- Women who are pregnant or plan to become pregnant in the next 3-4 months
- Orthopedic injury/limitation or any other contraindications to exercise.
- Medications that cause weight gain (steroids, HIV-related medications, etc.), or glucose lowering medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Walking
This arm is prescribed standard of care exercise prescription; 30 minutes of moderate intensity walking, 5 days/week.
|
Walking prescribed to meet current exercise guidelines; 150 minutes per week.
|
Experimental: Interval Training
This arm is prescribed body-weight based interval training 3 days per week with progressive increase in exercise intervals and sets.
|
Interval training is prescribed 3 days per week using 5 body weight exercises in a progressive fashion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body fat percent
Time Frame: 12 weeks
|
DEXA derived body fat %
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Weight
Time Frame: 12 weeks
|
Weight in kilograms
|
12 weeks
|
Change in peak VO2
Time Frame: 12 weeks
|
Peak VO2 in ml/kg/min
|
12 weeks
|
Visceral adipose tissue area
Time Frame: 12 weeks
|
cm^2
|
12 weeks
|
Thigh adipose tissue area
Time Frame: 12 weeks
|
cm^2
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amanda R Bonikowske, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-010163
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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