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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03524521
Other study ID # 17-010163
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 6, 2018
Est. completion date January 8, 2021

Study information

Verified date January 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Body-weight based interval training (IT) performed 3 times per week will lead to reductions in abdominal adiposity and reduce overall body fat percentage in overweight and obese sedentary adults more effectively than moderate intensity continuous training (MICT). Body-weight interval training will improve exercise capacity (peak VO2) in overweight/obese adults.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date January 8, 2021
Est. primary completion date January 8, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Behavioral:
Interval Training
Interval training is prescribed 3 days per week using 5 body weight exercises in a progressive fashion.
Standard of Care
Walking prescribed to meet current exercise guidelines; 150 minutes per week.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Body fat percent DEXA derived body fat % 12 weeks
Secondary Change in Weight Weight in kilograms 12 weeks
Secondary Change in peak VO2 Peak VO2 in ml/kg/min 12 weeks
Secondary Visceral adipose tissue area cm^2 12 weeks
Secondary Thigh adipose tissue area cm^2 12 weeks
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