Visual Feedback Monitoring During Exercise in Individuals With Obesity

NCT04685707 | Completed Results

• 1 other identifier: 19-607
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Mean Tibial Positive Peak Acceleration

  Up to 4 weeks

• Heart Rate Error

  1 day

Study Arms (2)

HFFS, then Control

EXPERIMENTAL

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); Other: Control

Control, then HFFS

EXPERIMENTAL

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); Other: Control

Interventions

Visual feedback monitoring system (HFFS) DEVICE

Participants will follow the exercise monitoring system's instructions displayed on a TV. Treadmill walking speed will be set at a comfortable walking speed.

Control, then HFFS; HFFS, then Control

Control OTHER

Participants will monitor the intensity of exercise independently using a standard heart rate monitor and control it by adjusting the treadmill speed (walking speed).

Control, then HFFS; HFFS, then Control

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

The University of Southern Mississippi

Hattiesburg, Mississippi, 39402, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Nuno Oliveira
• Organization: University of Southern Mississippi

nuno.oliveira@usm.edu

6012665804

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 28, 2020
• Study Start: September 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2023
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)