Fall Clinical Trial
— Cyclepad PilotOfficial title:
Improvement of Motivation for Physical Activity in an Institutionalized Geriatric Population Thanks to a Virtual Environment: Comparison of Motivation Between Classic Bike and Bike With Virtual Environment
| NCT number | NCT03834545 |
| Other study ID # | ARUET |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2018 |
| Est. completion date | June 30, 2018 |
| Verified date | February 2019 |
| Source | University Hospital, Caen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to test the interest of a virtual environment with cycling to increase the motivation of physical activity practice in institutionalized older adults.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | June 30, 2018 |
| Est. primary completion date | May 15, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - age over 65 - ability to cycle Exclusion Criteria: - unstable cardiopathy - New York Heart Association classification III or IV - severe cognitive disorders with inability to follow simple orders (follow investigator, ride on the ergometric bicycles, pedal) - visual disturbance preventing counting fingers at 5m |
| Country | Name | City | State |
|---|---|---|---|
| France | Caen University Hospital | Caen | Normandy |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Caen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cycling distance in meters | Primary outcome was the cycling distance measured at each session without encouragement | 3 months | |
| Secondary | Time spent pedaling in seconds per session | Measure of the time spent pedaling per session without encouragement | 3 months | |
| Secondary | The average speed in meters per second per session | Measure of the average cycling speed per session without encouragement. | 3 months | |
| Secondary | Mean pedaling cadence per session in revolutions per minute | Measure of the average pedaling cadence per session without encouragement. | 3 months | |
| Secondary | Borg rating of perceived exertion scale | Measure of the perceived exertion after each cycling session with Borg rating of perceived exertion scale. Range 0-10. Ten corresponding to the maximal perceived exertion | 3 months | |
| Secondary | Mean pedaling power per session in Watts | Measure of the pedaling power per session without encouragement | 3 months | |
| Secondary | Closed-ended question to know which condition they would prefer for a futur exercise session. | Participant were asked at the end of the third session, which condition they would prefer for a futur exercice session. Possible answers: "Classic ergometric bicycle Kettler E3)", "Cycleo without virtual environment", "Cycleo with virtual environment", "None". | 3 months |
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