End-stage Renal DiseaseNCT05404633
Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting
A study testing Ergogycle prototype testing for acceptability in people with End-stage Renal Disease, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Hospitalizations are harmful to patients. Without a proper intervention, it will lead to a permanent decline in physical function, especially among frail individuals. Ultimately, this will worsen quality of life, as well as the cognitive and functional status of affected elderly people, which will arguably reduce… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Ergogycle prototype testing for acceptability
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 31 Aug 2021to May 2023
- Phase
- Interventional
- 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
Who may be able to join
- > 55 years old
- receiving treatments for terminal renal insufficiency at least 3 times a week, for at least 3 months (hemodialysis; HD) or under mechanical ventilation for less than 72 hours, and that should last for at least 24 more hours (intensive unit care; ICU)
- Physically independent outside HD or before admission (ICU) (≥ 70 on the Barthel index)
- with medical clearance (HD : nephrologist; ICU : intensivist)
Who cannot join
- unable to walk without assistance (before ICU admission)
- diagnosed neurocognitive decline
- recent hemiarthroplasty for a hip fracture that causes a limitation in the flexion of the hip during pedaling
- already involved in another study
- neuromuscular disorder affecting the weaning from mechanical ventilator support
- pathologic fracture or unstable cervical spine fracture
Show all 9Show fewer
- hospitalized for more than 7 days
- COVID-19 positive
- reported as moribund by the intensivist
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1H 5N4
Godin Mélanie, MD, melanie.godin@usherbrooke.ca
About this study
Hospitalizations are harmful to patients. Without a proper intervention, it will lead to a permanent decline in physical function, especially among frail individuals. Ultimately, this will worsen quality of life, as well as the cognitive and functional status of affected elderly people, which will arguably reduce functional independence, increase post-discharge institutionalization and death among frail older adults. It is known that patients receiving early physical evaluation and rehabilitation (in the 24 hours following admission) improves post-discharge orientation, decreases delirium and the need of acute care. The rehabilitation often involves ergocycles, but commercially available devices are expensive and often hard to move, to set up in hospital bed and lack connectivity.
In this context, a connected ergocycle prototype which has a number of desired characteristics, including low production cost, relatively light and easy to move and with internet connectivity. The goal of this study is thereby to assess the usefulness and acceptability of the prototype with health professionals involved in physical rehabilitation and patients receiving said rehabilitation.
- Conditions
- End-stage Renal Disease
- Being tested
- Ergogycle prototype testing for acceptability
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergogycle prototype testing for acceptabilityDevice
The objective was to assess the acceptability of the ergogycle prototype (device) while used in a clinical settings by both the patients and the professionals.
| Study group | Role | What they receive |
|---|---|---|
| Intradialytic exercise (patients) | Experimental | Participants in this group will use the tested device to perform a 30-minute session of aerobic training (cycling during hemodialysis) at 3-4/10 on the Borg scale of perceived exertion. Receives: Device: Ergogycle prototype testing for acceptability |
| Acute care exercise (patients) | Experimental | Participants in this group will use the tested device to perform 2 x 10-minute of aerobic training (cycling in the hospital) interspersed with a 5-minute break. Exercise intensity will be of 2/10 on the Borg scale of perceived exertion (around 3 +/- 2 watts at 20 rpm). Receives: Device: Ergogycle prototype testing for acceptability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the device
Questionnaire based on the unified theory of acceptance and use of technology
Measured: up to 1 hour after the exercise session for both the patients and professionals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start31 Aug 2021
- Primary completion1 Sep 2022
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404633
- Sponsor's protocol ID
- MP-31-2021-4146
- Status last verified
- Mar 2023
- First submitted
- 8 Jul 2021
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting
- ClinicalTrials.gov ID
- NCT05404633
- Acronym / sponsor ID
- MP-31-2021-4146
- Conditions
- End-stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- May 2023 (estimated)
- First posted
- 3 Jun 2022 (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.
Hospitalizations are harmful to patients. Without a proper intervention, it will lead to a permanent decline in physical function, especially among frail individuals. Ultimately, this will worsen quality of life, as well as the cognitive and functional status of affected elderly people, which will arguably reduce functional independence, increase post-discharge institutionalization and death among frail older adults. It is known that patients receiving early physical evaluation and rehabilitation (in the 24 hours following admission) improves post-discharge orientation, decreases delirium and the need of acute care. The rehabilitation often involves ergocycles, but commercially available devices are expensive and often hard to move, to set up in hospital bed and lack connectivity.
In this context, a connected ergocycle prototype which has a number of desired characteristics, including low production cost, relatively light and easy to move and with internet connectivity. The goal of this study is thereby to assess the usefulness and acceptability of the prototype with health professionals involved in physical rehabilitation and patients receiving said rehabilitation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradialytic exercise (patients) | Experimental | Device: Ergogycle prototype testing for acceptabilityParticipants in this group will use the tested device to perform a 30-minute session of aerobic training (cycling during hemodialysis) at 3-4/10 on the Borg scale of perceived exertion. |
| Acute care exercise (patients) | Experimental | Device: Ergogycle prototype testing for acceptabilityParticipants in this group will use the tested device to perform 2 x 10-minute of aerobic training (cycling in the hospital) interspersed with a 5-minute break. Exercise intensity will be of 2/10 on the Borg scale of perceived exertion (around 3 +/- 2 watts at 20 rpm). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- > 55 years old
- receiving treatments for terminal renal insufficiency at least 3 times a week, for at least 3 months (hemodialysis; HD) or under mechanical ventilation for less than 72 hours, and that should last for at least 24 more hours (intensive unit care; ICU)
- Physically independent outside HD or before admission (ICU) (≥ 70 on the Barthel index)
- with medical clearance (HD : nephrologist; ICU : intensivist)
Key exclusion criteria (9 listed)
- unable to walk without assistance (before ICU admission)
- diagnosed neurocognitive decline
- recent hemiarthroplasty for a hip fracture that causes a limitation in the flexion of the hip during pedaling
- already involved in another study
- neuromuscular disorder affecting the weaning from mechanical ventilator support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergogycle prototype testing for acceptabilityThe objective was to assess the acceptability of the ergogycle prototype (device) while used in a clinical settings by both the patients and the professionals. | Device | Acute care exercise (patients), Intradialytic exercise (patients) |
Primary outcome
Acceptability of the device
Time frame: up to 1 hour after the exercise session for both the patients and professionals
Questionnaire based on the unified theory of acceptance and use of technology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergogycle prototype testing for acceptability in people with End-stage Renal Disease, run by Université de Sherbrooke at 1 site in Canada.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 Mar 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eléonor Riesco, PhD (1-819-821-8000 ext. 63337, eleonore.riesco@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the device (time frame: up to 1 hour after the exercise session for both the patients and professionals). 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 30 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.