Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting
Primary Purpose
End-stage Renal Disease
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ergogycle prototype testing for acceptability
Sponsored by
About this trial
This is an interventional other trial for End-stage Renal Disease
Eligibility Criteria
Inclusion Criteria :
- > 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)
Exclusion Criteria:
- 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
Exclusion Criteria Specific for ICU Patients :
- neuromuscular disorder affecting the weaning from mechanical ventilator support
- pathologic fracture or unstable cervical spine fracture
- hospitalized for more than 7 days
- COVID-19 positive
- reported as moribund by the intensivist
Sites / Locations
- CIUSSS de l'Estrie - CHUSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intradialytic exercise (patients)
Acute care exercise (patients)
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Acceptability of the device
Questionnaire based on the unified theory of acceptance and use of technology
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05404633
Brief Title
Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting
Official Title
Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intradialytic exercise (patients)
Arm Type
Experimental
Arm Description
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.
Arm Title
Acute care exercise (patients)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Ergogycle prototype testing for acceptability
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of the device
Description
Questionnaire based on the unified theory of acceptance and use of technology
Time Frame
up to 1 hour after the exercise session for both the patients and professionals
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria :
> 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)
Exclusion Criteria:
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
Exclusion Criteria Specific for ICU Patients :
neuromuscular disorder affecting the weaning from mechanical ventilator support
pathologic fracture or unstable cervical spine fracture
hospitalized for more than 7 days
COVID-19 positive
reported as moribund by the intensivist
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eléonor Riesco, PhD
Phone
1-819-821-8000
Ext
63337
Email
eleonore.riesco@usherbrooke.ca
Facility Information:
Facility Name
CIUSSS de l'Estrie - CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Godin Mélanie, MD
Email
melanie.godin@usherbrooke.ca
12. IPD Sharing Statement
Learn more about this trial
Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting
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