Development of the GameCycle Exercise System: Phase II

This study has been completed.
Sponsor:
Information provided by:
VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier:
NCT00232609
First received: September 30, 2005
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Wheelchair Users
Device: GameCycle Exercise System
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Development of the GameCycle Exercise System: Phase II

Resource links provided by NLM:


Further study details as provided by VA Pittsburgh Healthcare System:

Primary Outcome Measures:
  • Physiologic and Metabolic activity (VO2, VCO2, HR) [ Designated as safety issue: No ]
  • Ratings of perceived exertion [ Designated as safety issue: No ]
  • Questionnaire responses [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: August 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232609

Locations
United States, Pennsylvania
Human Engineering Research Laboratories
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
VA Pittsburgh Healthcare System
Investigators
Principal Investigator: Rory A Cooper, PhD University of Pittsburgh and VA Pittsburgh Healthcare System
  More Information

Additional Information:
No publications provided

Responsible Party: Rory Cooper, PhD, Human Engineering Research Laboratories
ClinicalTrials.gov Identifier: NCT00232609     History of Changes
Other Study ID Numbers: 02254, 0410155, 2R44HD039535-02A1
Study First Received: September 30, 2005
Last Updated: September 17, 2012
Health Authority: United States: Federal Government

Keywords provided by VA Pittsburgh Healthcare System:
Wheelchair
Exercise
Cardiovascular Disease

ClinicalTrials.gov processed this record on September 16, 2014