Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting

End-stage Renal Disease Clinical Trial

Official title:

Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05404633
• Other study ID #: MP-31-2021-4146
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: May 2023

Study information

• Verified date: March 2023
• Source: Université de Sherbrooke
• Contact: Eléonor Riesco, PhD
• Phone: 1-819-821-8000
• Email: eleonore.riesco[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Ergogycle prototype testing for acceptability
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.

Locations

Country	Name	City	State
Canada	CIUSSS de l'Estrie - CHUS	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the device	Questionnaire based on the unified theory of acceptance and use of technology	up to 1 hour after the exercise session for both the patients and professionals