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CompletedNCT00232609Updated Sep 18, 2012

Development of the GameCycle Exercise System: Phase II

A Phase 2 interventional study of GameCycle Exercise System in Wheelchair Users, sponsored by VA Pittsburgh Healthcare System. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-18.

Sponsored by VA Pittsburgh Healthcare System · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of this research project is to further develop and test the effectiveness of a novel exercise system for wheelchair users, the Game Cycle.

Read the detailed description

The purpose of this research project is to further develop and test the effectiveness of a novel exercise system for wheelchair users, the GAMECycle. People in wheelchairs who have a desire to exercise are faced with barriers with respect to access to exercise equipment and to availability of exercise equipment that is specifically suitable for use with a wheelchair. The GAMECycle exercise system removes these barriers and offers the wheelchair user an entertaining, motivational environment in which to exercise. The long-term goal is to improve the overall activity level of individuals who use wheelchairs as their primary means of mobility and increase their general well being.

The GAMECycle Exercise System is a modified arm-ergometer that sits on a turnstile to allow steering in much the same way as an arm-cycle. More specifically, it is a crank and pedal set that is turned using the arms, similar to a bicycle that is turned with the feet. When using the system, subjects will be seated in their own wheelchair in front of the system comfortably positioned to be able to grasp the handles and use the arm crank. The GAMECycle is designed to provide upper body aerobic exercise in an environment (computer game play) that will help to make exercise more enjoyable by, among other things, distracting people from some of the less pleasant aspects of exercising. Although upper-body exercise systems for wheelchair users do exist, the GAMECycle is unique in its ability to combine arm-ergometry with playing computer videogames. And, in contrast to wheelchair roller systems, the arm-ergometry provided by the GAMECycle affords the user an exercise option that uses a motion that differs significantly from the motion of wheelchair propulsion.

This research consists of two phases: a Training Phase and an In Home Trial Phase. The training phase will last a maximum of two hours and the In Home Phase will last 4 months. Subjects who complete the Training Phase will be asked to participate in the In Home Trial.

Training Phase The purpose of the training sessions are to determine the users ability to reach and maintain target aerobic training zones during 15 minute exercise trials, teach new users how to use the GAMECycle Exercise System, and to obtain feedback from new users regarding perceived comfort, fit, and ease of use.

A GAMECycle exercise system will be set up in participating local rehab and research facilities. A clinician will ensure that the GAMECycle is adjusted to fit each user. The amount of resistance from the arm-ergometer will be adjusted to a level that feels comfortable during exercise. Heart rate and breathing rate will be monitored during a 15-minute exercise session. Subjects will rate their level of exertion every 2 minutes during the 15-minute exercise phase and will be asked to complete a questionnaire about their opinion of the GAMECycle System.

In Home Phase This phase involves a 4-month trial period divided into 2 two-month sessions. For two months, subjects will be asked to use the GAMECycle and for the other two months, subjects will be asked to use an arm-ergometer. It will randomly be determined whether the GAMECycle or the arm-ergometer is used first. Subjects will be required to record their exercise sessions and will be followed by a member of the research team by telephone. In addition, once a month for four months, a member of our research staff will visit each participant with a portable metabolic cart and heart rate monitor in order to collect heart rate date, metabolic date (VO2, VCO2), and ratings of perceived exertion using the Borg scale. This data will be collected during exercise with or without game play, depending on the condition of that session.

02

Conditions studied

  • Wheelchair Users

Keywords

  • Wheelchair
  • Exercise
  • Cardiovascular Disease
03

In context

Lead sponsor

VA Pittsburgh Healthcare System is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Use of a wheelchair as primary means of mobility (use a wheelchair > 20 hours per week)
  2. Between ages 18 and 50
  3. Able to use an arm-cycle

Exclusion criteria

Exclusion Criteria:

  1. Any history of cardiovascular or cardiopulmonary disease for the participant, or a history of CVD in their family (e.g., parents, grandparents, and siblings) which will be defined as death as a result of CVD prior to the age of 55.
  2. If a subject answers yes to any question on the PAR-Q.
05

Study design

Phase
Phase 2
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Interventions

  • DeviceGameCycle Exercise System
06

What researchers measure

Primary outcomes

  1. Physiologic and Metabolic activity (VO2, VCO2, HR)

  2. Ratings of perceived exertion

  3. Questionnaire responses

07

Study locations

1 site
  • Human Engineering Research Laboratories
    Pittsburgh, Pennsylvania 15206, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00232609
Lead sponsor
VA Pittsburgh Healthcare System
First posted
Oct 4, 2005
Start date
Aug 2005
Primary completion
Jul 2007
Completion
Jul 2007
Last update
Sep 18, 2012

Study contacts

Rory A Cooper, PhD
principal investigator · University of Pittsburgh and VA Pittsburgh Healthcare System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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