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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Southern Mississippi | Hattiesburg | Mississippi | 39402 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HFFS Session |
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| Washout |
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| Control Session |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants were randomized to receive all interventions: 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. 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | ml/kg/min | 1 Day |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HFFS | Visual feedback monitoring system: Participants will follow the exercise monitoring system's instructions displayed on a TV. Treadmill walking speed will be set at a comfortable walking speed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nuno Oliveira | University of Southern Mississippi | 6012665804 | nuno.oliveira@usm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2021 | May 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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). |
|
| 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 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Heart Rate (Bpm) | Average heart rate (bpm) during steady state period of exercise. | Posted | Mean | Standard Deviation | bpm | 1 day |
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| Primary | Percentage of Strides With Tibia Peak Positive Accelerations Above 3g | Posted | Mean | Standard Deviation | % of strides | 1 day |
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| Secondary | 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. | Posted | Mean | Standard Deviation | g | Up to 4 weeks |
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | bpm | 1 day |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control | 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). | 0 | 20 | 0 | 20 | 0 | 20 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |