Visual Feedback Monitoring During Exercise in Individuals With Obesity
Primary Purpose
Obesity
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visual feedback monitoring system
Control
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- BMI ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2
- Age 20 to 45 years;
- Able to understand spoken English at the level needed to:
- understand and follow instructions for equipment setup, testing, and task performance
- answer questions related to effort and preference
- be able to understand consent document and provide informed assent
Exclusion Criteria:
- Any signs or symptoms suggestive of cardiovascular, pulmonary, metabolic, or renal disease.
- Any injury or health condition that affects the ability to walk on a treadmill.
Sites / Locations
- The University of Southern Mississippi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Active-Sedentary Control
Active-Sedentary Experimental
Arm Description
Outcomes
Primary Outcome Measures
Energy expenditure
Energy expenditure (J) resulting from the exercise session
Secondary Outcome Measures
Heart rate
Average and Maximum heart rate (bpm) resulting from the exercise session
Tibial positive peak acceleration
Tibial positive peak accelerations (g) resulting from the exercise session
Maximum hip flexion
Maximum hip flexion angles (degrees) resulting from the exercise session.
Full Information
NCT ID
NCT04685707
First Posted
December 10, 2020
Last Updated
March 13, 2023
Sponsor
University of Mississippi Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04685707
Brief Title
Visual Feedback Monitoring During Exercise in Individuals With Obesity
Official Title
Visual Feedback Monitoring During Exercise in Individuals With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Mississippi Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Exercise has been shown to offer numerous health benefits and be particularly important in preventing weight gain or regain for people with obesity. Exercise guidelines can be difficult to interpret and apply independently and do not address specific exercise limitations in individuals with obesity. The exercise monitoring system proposed in this study might provide a new method to meet aerobic exercise guidelines independently with reduced risk of injury.
The exercise monitoring system controls, in real-time, the intensity of an exercise session consisting of treadmill walking. During treadmill walking, the exercise monitoring system will instruct participants to increase or decrease how much participants raise their knees and swing their arms while maintaining a smooth contact with the ground, based on real-time readings of the participants' heart rate.
In this clinical trial, each participant will perform a control and an experimental training session. Both training sessions will include four blocks of 7 minutes of treadmill walking alternated with three periods of rest (3 min). In the control session, participants will monitor the intensity of exercise independently using a standard heart rate monitor and control it by adjusting their walking speed. In the experimental session, each participant will follow the exercise monitoring system instructions displayed on a TV, and treadmill walking speed will be set at a comfortable walking speed. Target heart rates of 40% and 60% HRR will be used as the exercise intensities in both training sessions. The investigators will examine energy expenditure, heart rate, and kinematic measures under control and experimental conditions. The goals of this clinical trial are to determine the effect of exercising with the exercise monitoring system in individuals with obesity. The investigators hypothesized that the experimental session will result in higher total energy cost and efficiency than the control session; and in lower heart rate error, tibial positive peak accelerations and feedback errors than the control session. The investigators will also compare the effect of the exercise monitoring system between active and sedentary individuals with obesity.
The results of this study will inform proposals for larger interventions that will focus on 1) testing different types of obesity and osteoarthritis, 2) adding a resistance-training component, and 3) integrating a diet intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active-Sedentary Control
Arm Type
Active Comparator
Arm Title
Active-Sedentary Experimental
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Visual feedback monitoring system
Intervention Description
Participants will follow the exercise monitoring system's instructions displayed on a TV. Treadmill walking speed will be set at a comfortable walking speed.
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Participants will monitor the intensity of exercise independently using a standard heart rate monitor and control it by adjusting the treadmill speed (walking speed).
Primary Outcome Measure Information:
Title
Energy expenditure
Description
Energy expenditure (J) resulting from the exercise session
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Heart rate
Description
Average and Maximum heart rate (bpm) resulting from the exercise session
Time Frame
Up to 4 weeks
Title
Tibial positive peak acceleration
Description
Tibial positive peak accelerations (g) resulting from the exercise session
Time Frame
Up to 4 weeks
Title
Maximum hip flexion
Description
Maximum hip flexion angles (degrees) resulting from the exercise session.
Time Frame
Up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2
Age 20 to 45 years;
Able to understand spoken English at the level needed to:
understand and follow instructions for equipment setup, testing, and task performance
answer questions related to effort and preference
be able to understand consent document and provide informed assent
Exclusion Criteria:
Any signs or symptoms suggestive of cardiovascular, pulmonary, metabolic, or renal disease.
Any injury or health condition that affects the ability to walk on a treadmill.
Facility Information:
Facility Name
The University of Southern Mississippi
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Visual Feedback Monitoring During Exercise in Individuals With Obesity
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