Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232609
Status:
COMPLETED
Last Update Posted:
2012-09-18
First Post:
2005-09-30
Brief Title:
Development of the GameCycle Exercise System Phase II
Sponsor:
VA Pittsburgh Healthcare System
Organization:
VA Pittsburgh Healthcare System
Study Overview
Official Title:
Development of the GameCycle Exercise System Phase II
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R44HD039535-02A1 | NIH | None | httpsreporternihgovquickSearch2R44HD039535-02A1 |