Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733365
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2017-11-13
Brief Title:
Exercise in Patients Admitted With Recently Decompensated Heart Failure
Sponsor:
Centro Hospitalar do Porto
Organization:
Centro Hospitalar do Porto
Study Overview
Official Title:
Nursing Rehabilitation on Patients Admitted by Recently Decompensated Heart Failure ERIC Program - Impact of Exercise
Status:
COMPLETED
Status Verified Date:
2021-01
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:
ERIC
Brief Summary:
An aerobic physical exercise protocol will be applied to patients admitted in ward due to decompensated heart failure in order to validate the efficacy and safety of physical exercise in this phase of clinical stabilization through the said training protocol - ERIC program
Detailed Description:
With the objective of validating the efficacy and safety of physical exercise as a therapeutic resource in patients admitted for decompensated heart failure will be applied by rehabilitation nurses a protocol of physical exercise with increasing levels of intensity Patients who meet the inclusion criteria will be randomized through an online program randomizerorg and the ERIC protocol will be applied to the test group The control group will be implemented the usual care of rehabilitation nursing The ERIC protocol comprises 5 levels of intensity as following shown
Stage 1 - respiratory and calisthenic exercises 5-10 minutes Stage 2 - pedaler for 5-10 minutes Stage 3 - aerobic training walking on the corridor for 5-10 minutes Stage 4 - aerobic training walking on the corridor for 10-15 minutes Stage 5 - aerobic training walking on the corridor for 15 minutes climbing stairs for 5 minutes
All patients will be monitored and followed up by a rehabilitation nurse while they are doing the exercise The investigator decides depending on the patients performance and clinical conditions the form of progression in the program but it is mandatory to follow the previously defined levels of intensity Patients in the test group may start the program only on stage I or II according to clinical criteria
At admission of the patients test group and control group clinical and sociodemographic parameters are evaluated as well as data related to Barthels indices and London Chest of activities of daily living LCADL At the discharge date the Barthel index and the LCADL scale will also be evaluated as well as the 6-minute walking test
Stage 1 - respiratory and calisthenic exercises 5-10 minutes Stage 2 - pedaler for 5-10 minutes Stage 3 - aerobic training walking on the corridor for 5-10 minutes Stage 4 - aerobic training walking on the corridor for 10-15 minutes Stage 5 - aerobic training walking on the corridor for 15 minutes climbing stairs for 5 minutes
All patients will be monitored and followed up by a rehabilitation nurse while they are doing the exercise The investigator decides depending on the patients performance and clinical conditions the form of progression in the program but it is mandatory to follow the previously defined levels of intensity Patients in the test group may start the program only on stage I or II according to clinical criteria
At admission of the patients test group and control group clinical and sociodemographic parameters are evaluated as well as data related to Barthels indices and London Chest of activities of daily living LCADL At the discharge date the Barthel index and the LCADL scale will also be evaluated as well as the 6-minute walking test
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