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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2019
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

The World Health Organization (WHO) recommends for people aged 65 years and over a weekly practice of at least 150 minutes of moderate-intensity endurance activities or at least 75 minutes of activity. endurance of sustained intensity, or an equivalent combination of moderate and sustained activity. However, the attractiveness for physical activity fades over the years limiting the practice of physical activity. Several types of unconventional approaches have already shown their effectiveness in the prevention of falls in the elderly but these practices find their limits in the lack of adherence to this type of exercise, especially in nursing homes. New virtual reality and gaming technologies have recently emerged and are being used as tools to prevent the risk of falling. The use of these new tools has advantages over conventional exercises: motivating. The investigators aimed to test the interest of a virtual environment with cycling to increase the motivation of physical activity practice in institutionalized older adults.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Caen University Hospital Caen Normandy

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

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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