Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313684
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-04
Brief Title:
Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure
Sponsor:
Universidad de La Frontera
Organization:
Universidad de La Frontera
Study Overview
Official Title:
Comprehensive Hybrid Cardiac Rehabilitation Trial to Assess Impact on Heart Failure Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
COCREATIONHF
Brief Summary:
CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone
Detailed Description:
Comprehensive hybrid cardiac rehabilitation CR models have been scantly investigated in heart failure HF populations particularly in low-resource settings
A 2 parallel-arm multi-center randomized clinical superiority trial will be conducted with blinded outcome assessment 152 HF patients NYHA class II or III will be recruited consecutively and randomly assigned The experimental intervention will include evaluation medical and nurse management aerobic interval training resistance exercise psychosocial support and education These will initially be delivered in a center transitioning to home in 4 stages Participants in the control arm will receive face-to-face continuous aerobic exercise sessions and resistance exercises The main outcomes are cardiorespiratory fitness functional capacity and quality of life These will be measured at baseline end of intervention and 12-month follow-up
The pragmatic comprehensive hybrid CR model could be implemented more broadly if superiority is demonstrated
A 2 parallel-arm multi-center randomized clinical superiority trial will be conducted with blinded outcome assessment 152 HF patients NYHA class II or III will be recruited consecutively and randomly assigned The experimental intervention will include evaluation medical and nurse management aerobic interval training resistance exercise psychosocial support and education These will initially be delivered in a center transitioning to home in 4 stages Participants in the control arm will receive face-to-face continuous aerobic exercise sessions and resistance exercises The main outcomes are cardiorespiratory fitness functional capacity and quality of life These will be measured at baseline end of intervention and 12-month follow-up
The pragmatic comprehensive hybrid CR model could be implemented more broadly if superiority is demonstrated
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