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

Not Applicable

Recruiting

• Conditions: End-stage Renal Disease
• Interventions: Device: Ergogycle prototype testing for acceptability

• Registration Number: NCT05404633
• Lead Sponsor: Université de Sherbrooke

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-08
• Study Start: 2021-08-31
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-03
• Primary Completion: 2022-09-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intradialytic exercise (patients)	Ergogycle prototype testing for acceptability	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.
Acute care exercise (patients)	Ergogycle prototype testing for acceptability	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).

Primary Outcome Measures

Name	Time	Method
Acceptability of the device	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

Trial Locations

Locations (1)

CIUSSS de l'Estrie - CHUS; 🇨🇦 Sherbrooke, Quebec, Canada