Trial Outcomes & Findings for Visual Feedback Monitoring During Exercise in Individuals With Obesity (NCT NCT04685707)

Last Updated: 2024-09-23

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

1 Day

Results posted on

2024-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
HFFS Session STARTED	11	9
HFFS Session COMPLETED	11	9
HFFS Session NOT COMPLETED	0	0
Washout STARTED	11	9
Washout COMPLETED	11	9
Washout NOT COMPLETED	0	0
Control Session STARTED	11	9
Control Session COMPLETED	11	9
Control Session NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Visual Feedback Monitoring During Exercise in Individuals With Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=20 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).
Age, Continuous	24.3 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

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).

Outcome measures

Outcome measures
Measure	HFFS n=20 Participants 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.	Control n=20 Participants 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).
Energy Expenditure (Oxygen Consumption)	20.2 ml/kg/min Standard Deviation 5.8	22.8 ml/kg/min Standard Deviation 6.1

PRIMARY outcome

Timeframe: 1 day

Average heart rate (bpm) during steady state period of exercise.

Outcome measures

Outcome measures
Measure	HFFS n=20 Participants 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.	Control n=20 Participants 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).
Heart Rate (Bpm)	149 bpm Standard Deviation 4.5	151 bpm Standard Deviation 3.8

PRIMARY outcome

Timeframe: 1 day

Outcome measures

Outcome measures
Measure	HFFS n=20 Participants 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.	Control n=20 Participants 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).
Percentage of Strides With Tibia Peak Positive Accelerations Above 3g	23.8 % of strides Standard Deviation 27.6	54.0 % of strides Standard Deviation 31.0

SECONDARY outcome

Timeframe: Up to 4 weeks

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.

Outcome measures

Outcome measures
Measure	HFFS n=20 Participants 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.	Control n=20 Participants 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).
Mean Tibial Positive Peak Acceleration	3.5 g Standard Deviation 0.2	4.0 g Standard Deviation 0.9

SECONDARY outcome

Timeframe: 1 day

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.

Outcome measures

Outcome measures
Measure	HFFS n=20 Participants 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.	Control n=20 Participants 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).
Heart Rate Error	3.3 bpm Standard Deviation 2.0	2.8 bpm Standard Deviation 1.5

Adverse Events

HFFS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nuno Oliveira

University of Southern Mississippi

Phone: 6012665804

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place