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Completed

NCT Number: NCT02990507

Advanced Virtual Exercise Environment Device for Use by Persons With Physical Disabilities

An Advanced Virtual Exercise Environment Device (AVEED) has been developed that incorporates arm and leg ergometers in conjunction with a virtual reality interface. The purpose of this study is to examine participant perspectives regarding the virtual interface and exercise device combination with regard to usability, comfort, safety, rating of perceived exertion, and enjoyment.

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Key information

Conditions

Physically Disabled Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univerisity of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

Individuals with physical disabilities show much lower rates of exercise participation than their able-bodied peers (Boslaugh et al. 2006, Preventing Chronic Disease). Much of the reason for the low rates of activity among this population come from the presence of barriers. Lack of motivation, lack of transportation, lack of accessible facilities and equipment, and cost are all factors that discourage exercise participation among those with disabilities (Rimmer et al. 2008, JRRD; Barfield and Malone 2013, JRRD). Based on these factors, there is a need for accessible enjoyable exercise options for people with physical disabilities. The AVEED is comprised of an ergometer with foot and hand pedals, and a visual display in front of the user that can show a variety of scenic pathways.

The AVEED builds on previous work that demonstrates the potential benefit of interactive exercise for those with physical disabilities. The present study will establish the potential of this device to provide an engaging moderate intensity exercise opportunity for persons with disabilities.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Greater than 18 years old
  • Mobility impairment, able to push a manual wheelchair

Exclusion criteria

  • Individuals without a disability
  • Individuals with vision loss that prevents them from seeing video elements on the screen
  • Individuals with unstable cardiovascular conditions
  • Individuals unable to push a manual wheelchair
  • Individuals unable to understand study directions.

Treatment and study plan

AVEED: Arm rotation, video display

Other

Participants rotate arm cranks for 5 minutes then rest for 5 minutes.

AVEED: Arm rotation, without video display

Other

Participants rotate arm cranks for 5 minutes then rest for 5 minutes.

AVEED: Leg rotation, arm-energy input, video display

Other

Participants rotate leg cranks for 5 minutes then rest for 5 minutes.

AVEED: Leg rotation, arm-energy input, without video display

Other

Participants rotate leg cranks for 5 minutes then rest for 5 minutes.

Primary outcomes

  1. Participant feedback

    Time frame: 2 days (approximately 48 hours) after enrolling

    Likert-style questions regarding ease of use, comfort, safety, and enjoyment related to using the device. Other questions will ask participants to compare the device with virtual interface to the device without the interface, as well as the likelihood of using their using the device if they had access to one.

Secondary outcomes

  1. Exercise intensity

    Time frame: 2 days (approximately 48 hours) after enrolling

    Percent heart rate reserve (%HRR) is a measure of exercise intensity and is calculated as (HR - HRrest)/(HRmax - HRrest). Maximum HR can be estimated using the Karvonen formula which states HRmax = 220 - age. The participant's HR will be monitored in real time via a Bluetooth enabled device strapped to the chest. The goal is for the participant to input energy into the AVEED system and maintain a rate that produces a HRR of approximately 60%. Exercising at a rate of 60% of their age-predicted HRR, would establish them within the range of intensity for cardiovascular improvement. Verbal cues will be provided to ensure participants stay between 50-70% of HRR. If the participant is unable to sustain this intensity they will be allowed to rest for 1-2 minutes and then start again. Data recorded by the system will include continuous HR and energy output (watts).

  2. Body orientation

    Time frame: 2 days (approximately 48 hours) after enrolling

    Video recordings will be used to assess how the participant's body is oriented in relation to the ergometer and their ease of use in rotating the cranks under the different conditions. the video will be scored using a 3 point likert scale: 1 being very poor body orientation to 3 being excellent orientation.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

Evaluation of an Advanced Virtual Exercise Environment Device (AVEED) for Use by Persons With Physical Disabilities

Acronym: AVEED

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2016
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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