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

NCT ID: NCT05404633

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2023-05-31

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.

Conditions

End-stage Renal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intradialytic exercise (patients)

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.

Group Type: EXPERIMENTAL

Ergogycle prototype testing for acceptability

Intervention Type: DEVICE

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.

Acute care exercise (patients)

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).

Group Type: EXPERIMENTAL

Ergogycle prototype testing for acceptability

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Eléonor Riesco, PhD

Role: CONTACT

eleonore.riesco@usherbrooke.ca

1-819-821-8000 ext. 63337

Facility Contacts

Godin Mélanie, MD

Role: primary

melanie.godin@usherbrooke.ca

Other Identifiers

MP-31-2021-4146

Identifier Type: -

Identifier Source: org_study_id