Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161987
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-07-19
Brief Title:
EACH-ADHF Early Comprehensive Rehabilitation in Patients With ADHF
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
Efficacy and Safety of Early Comprehensive Rehabilitation in Patients With ADHF A Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-12
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:
EACH-ADHF
Brief Summary:
EACH-ADHF Early Comprehensive Rehabilitation in patients with ADHF study is a multi-center parallel-group randomized controlled trial designed to evaluate the effects of the early comprehensive rehabilitation including exercise and inspiratory muscle training over a period of 6 weeks on the quality of life of patients with ADHF
Detailed Description:
Guangdong Provincial Peoples Hospital will be the lead center with an additional 12 hospitals designated as satellite centers for the study To sum up these centers will recruit a total of 140 consenting patients Following informed consent and baseline testing the participants will be randomized in a 11 fashion to receive a 6-week progressive comprehensive exercise training and inspiratory muscle training or attention control
The intervention group will receive an 6-week exercise program consisting of endurance resistance balance mobility and inspiratory muscle training The comprehensive rehabilitation will begin during the patients stay and continue to the outpatient clinic The control group will receive usual care with bi-weekly contact from study personnel The primary outcomes of the study are improvements in the summary score of KCCQ and PImaxpred while secondary endpoints include the impact on physical function cardiac function psychological status and major adverse cardiovascular events MACE Additionally the study will also explore the effects of comprehensive rehabilitation on hospital readmission and mortality rates with follow-up assessments planned up to 6 months after discharge
The intervention group will receive an 6-week exercise program consisting of endurance resistance balance mobility and inspiratory muscle training The comprehensive rehabilitation will begin during the patients stay and continue to the outpatient clinic The control group will receive usual care with bi-weekly contact from study personnel The primary outcomes of the study are improvements in the summary score of KCCQ and PImaxpred while secondary endpoints include the impact on physical function cardiac function psychological status and major adverse cardiovascular events MACE Additionally the study will also explore the effects of comprehensive rehabilitation on hospital readmission and mortality rates with follow-up assessments planned up to 6 months after discharge
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