Visual Feedback Monitoring During Exercise in Individuals With Obesity

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 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 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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Visual feedback monitoring system (HFFS); Other: Control

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39402
      • The University of Southern Mississippi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HFFS, then Control; Participants first performed the HFFS (increased hip flexion) exercise session. After a washout period of at least 24h, they then performed the Control (walking/running) exercise session.	Device: Visual feedback monitoring system (HFFS); Participants will follow the exercise monitoring system's instructions displayed on a TV. Treadmill walking speed will be set at a comfortable walking speed.; Other: Control; Participants will monitor the intensity of exercise independently using a standard heart rate monitor and control it by adjusting the treadmill speed (walking speed).
Experimental: Control, then HFFS; Participants first performed the Control (walking/running) exercise session. After a washout period of at least 24h, they then performed the HFFS (increased hip flexion) exercise session.	Device: Visual feedback monitoring system (HFFS); Participants will follow the exercise monitoring system's instructions displayed on a TV. Treadmill walking speed will be set at a comfortable walking speed.; Other: Control; Participants will monitor the intensity of exercise independently using a standard heart rate monitor and control it by adjusting the treadmill speed (walking speed).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy Expenditure (Oxygen Consumption)	Energy expenditure was evaluated from oxygen consumption (ml/kg/min) measured during the exercise and recovery bouts using a breath-by-breath portable metabolic analyzer (K5, COSMED, Rome, Italy).	1 Day
Heart Rate (Bpm)	Average heart rate (bpm) during steady state period of exercise.	1 day
Percentage of Strides With Tibia Peak Positive Accelerations Above 3g		1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Tibial Positive Peak Acceleration	Tibia axial accelerations were calculated using an IMU (Xsens Technologies BV, Enschede, Netherlands) aligned in the long axis of the participant's tibia attached to the anteromedial aspect of the distal tibia using double-sided adhesive tape. The mean peak positive acceleration (PPA) was calculated as the mean tibia PPA across all recorded strides for both sides during the exercise above 3g.	Up to 4 weeks
Heart Rate Error	Heart rate error (HRerr) was calculated as the absolute error between the target heart rate (HRtarget) and the actual heart rate during the steady state exercise. HRtarget corresponded to 60% heart rate reserve (HRR) of each participant. HRR was calculated as the difference between the estimated maximal heart rate and the resting heart rate. Maximal heart rate was estimated using the 220-age formula, and resting heart rate was measured using the heart rate monitor after at least 4 min of seated rest at the beginning of each session.	1 day

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 19-607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No