Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05868070
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-05-02
Brief Title:
Feasibility and Safety of In-bed CyclingStepping in Critically Ill Patients
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Feasibility and Safety of In-bed CyclingStepping in Critically Ill Patients A Study Protocol for a Pilot Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intensive care unit ICU-acquired weakness ICU-AW is one of the most common complications of post-ICU syndrome It is the leading cause of gait disturbance decreased activities of daily living and poor health-related quality of life The early rehabilitation of critically ill patients can reduce the ICU-AW We designed a protocol to investigate the feasibility and safety of conventional rehabilitation with additional in-bed cyclingstepping in critically ill patients The study is designed as a single-center open-label pilot randomized parallel-group study After the screening participants are randomly allocated to two groups stratified by mechanical ventilation status The intervention group will be provided with exercises of in-bed cyclingstepping according to the level of consciousness motor power and function in addition to conventional rehabilitation In contrast the control group will be provided with only conventional rehabilitation The length of the intervention is from ICU admission to discharge and interventions will be conducted for 20 minutes a maximum of three times per session The primary outcome is the number and percentage of completed in-bed cyclingstepping sessions the duration and percentage of in-bed cyclingstepping sessions and the number of cessations of in-bed cyclingstepping sessions The secondary outcomes are the interval from ICU admission to the first session of in-bed cyclingstepping the number and percentage of completed conventional rehabilitation sessions the duration and percentage of conventional rehabilitation sessions the number of cessations of conventional rehabilitation sessions the number of adverse events level of consciousness functional mobility muscle strength activities of daily living and quality of life This study is a pilot clinical trial to investigate the feasibility and safety of conventional rehabilitation with additional in-bed cyclingstepping in critically ill patients If the expected results are achieved in this study the methods of ICU rehabilitation will be enriched
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 202013C18 | OTHER_GRANT | the Korea Medical Device Development Fund | None |