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

Université de Sherbrooke

Status: Enrolling

Conditions: End-stage Renal Disease

Treatments: Device: Ergogycle prototype testing for acceptability

Study type: Interventional

Funder types: Other

Identifiers

NCT05404633

MP-31-2021-4146

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Intradialytic exercise (patients)

Experimental group

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.

Treatment:

Device: Ergogycle prototype testing for acceptability

Acute care exercise (patients)

Experimental group

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).

Treatment:

Device: Ergogycle prototype testing for acceptability