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

• Sponsor: Université de Sherbrooke (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05404633
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End-stage Renal Disease	Device: Ergogycle prototype testing for acceptability	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting
• Actual Study Start Date: Aug 31, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Experimental: 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).	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.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CIUSSS de l'Estrie - CHUS	Sherbrooke	Quebec	Canada	J1H 5N4

Sponsors and Collaborators

• Université de Sherbrooke

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Université de Sherbrooke
• ClinicalTrials.gov Identifier: NCT05404633
• Other Study ID Numbers: MP-31-2021-4146
• First Posted: Jun 3, 2022
• Last Update Posted: Jun 3, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Failure, Chronic

Study Results

No Results Posted as of Jun 3, 2022