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

NCT05404633 | Unknown

• 1 other identifier: MP-31-2021-4146
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intradialytic exercise (patients)

EXPERIMENTAL

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.

Device: Ergogycle prototype testing for acceptability

Acute care exercise (patients)

EXPERIMENTAL

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).

Device: Ergogycle prototype testing for acceptability

Interventions

Ergogycle prototype testing for acceptability 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); Intradialytic exercise (patients)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eléonor Riesco, PhD

CONTACT

1-819-821-8000; eleonore.riesco@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: June 3, 2022
• Study Start: August 31, 2021
• Primary Completion: September 1, 2022
• Study Completion: May 1, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

CA (1)