MotivationCyclepad PilotNCT03834545
Improved Motivation for Physical Activity in an Institutionalized Geriatric Population Through a Virtual Environment
An observational study of Motivation and Fall, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Motivation, Fall
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Institutionalized older adults over 65 years
Who may be able to join
- age over 65
- ability to cycle
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- Motivation, Fall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cycling group | They attended three sessions of exercise on three different conditions : a classic ergometric bicycle without chairback, an ergometric bicycle with chairback with virtual environment and the other session without virtual environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycling distance in meters
Primary outcome was the cycling distance measured at each session without encouragement
Measured: 3 months
Secondary outcomes (6)
Time spent pedaling in seconds per session
Measure of the time spent pedaling per session without encouragement
Measured: 3 months
The average speed in meters per second per session
Measure of the average cycling speed per session without encouragement.
Measured: 3 months
Mean pedaling cadence per session in revolutions per minute
Measure of the average pedaling cadence per session without encouragement.
Measured: 3 months
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
Measured: 3 months
Mean pedaling power per session in Watts
Measure of the pedaling power per session without encouragement
Measured: 3 months
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".
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Apr 2018
- Primary completion15 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834545
- Sponsor's protocol ID
- ARUET
- Acronym
- Cyclepad Pilot
- Status last verified
- Feb 2019
- First submitted
- 30 Jan 2019
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03834545
- Acronym / sponsor ID
- Cyclepad Pilot / ARUET
- Conditions
- Motivation, Fall
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cycling group | – | –They attended three sessions of exercise on three different conditions : a classic ergometric bicycle without chairback, an ergometric bicycle with chairback with virtual environment and the other session without virtual environment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Institutionalized older adults over 65 years
Key inclusion criteria (2 listed)
- age over 65
- ability to cycle
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cycling distance in meters
Time frame: 3 months
Primary outcome was the cycling distance measured at each session without encouragement
6 secondary outcomes
Time spent pedaling in seconds per session
Time frame: 3 months
The average speed in meters per second per session
Time frame: 3 months
Mean pedaling cadence per session in revolutions per minute
Time frame: 3 months
Borg rating of perceived exertion scale
Time frame: 3 months
Mean pedaling power per session in Watts
Time frame: 3 months
Closed-ended question to know which condition they would prefer for a futur exercise session.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motivation and Fall, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycling distance in meters (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.