NCT00232609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

September 18, 2012

Status Verified

September 1, 2012

Enrollment Period

1.9 years

First QC Date

September 30, 2005

Last Update Submit

September 17, 2012

Conditions

Wheelchair Users

Keywords

WheelchairExerciseCardiovascular Disease

Outcome Measures

Primary Outcomes (3)

  • Physiologic and Metabolic activity (VO2, VCO2, HR)

  • Ratings of perceived exertion

  • Questionnaire responses

Interventions

GameCycle Exercise SystemDEVICE

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.
  • If a subject answers yes to any question on the PAR-Q.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Engineering Research Laboratories

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Motor ActivityCardiovascular Diseases

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rory A Cooper, PhD

    University of Pittsburgh and VA Pittsburgh Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

August 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

September 18, 2012

Record last verified: 2012-09

Locations

US(1)