Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640140
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Effects of a Supervised Training Program on Functional Capacity in Patients With HF and Cardiorenal Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Cardiorenal Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Train-CR
Brief Summary:
This is a prospective study blinded for the evaluator randomized 11 to receive standard management alone or combined with a training program aerobic combined with strength exercises that will be carried out in a single center After randomization patients will be clinically evaluated The primary endpoint peakVO2 will be assessed by cardiopulmonary exercise testing combined with echocardiography echo-CPET at 12 weeks Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled A sample size estimation alfa 005 power 80 a 20 loss rate and at least a delta change of mean peakVO2 24 mLkgmin SD2 of 26 patients 13 per arm would be necessary to test our hypothesis
Detailed Description:
Heart failure HF is a highly prevalent clinical entity that predominantly affects elderly people with comorbidities Among these chronic kidney disease is particularly frequent complicating disease management and worsening prognosis Supervised training programs in patients with HF have improved functional capacity and reduced hospitalizations However the evidence is scarce regarding the effects of a supervised training program on patients with HF and cardiorenal syndrome This work aims to evaluate the effect of a supervised exercise program for 12 weeks in patients with HF and cardiorenal syndrome on peak oxygen consumption peakVO2
This is a prospective study blinded for the evaluator randomized 11 to receive standard management alone or combined with a training program aerobic combined with strength exercises that will be carried out in a single center After randomization patients will be clinically evaluated The primary endpoint peakVO2 will be assessed by cardiopulmonary exercise testing combined with echocardiography echo-CPET at 12 weeks Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled A sample size estimation alfa 005 power 80 a 20 loss rate and at least a delta change of mean peakVO2 24 mLkgmin SD2 of 26 patients 13 per arm would be necessary to test our hypothesis
This is a prospective study blinded for the evaluator randomized 11 to receive standard management alone or combined with a training program aerobic combined with strength exercises that will be carried out in a single center After randomization patients will be clinically evaluated The primary endpoint peakVO2 will be assessed by cardiopulmonary exercise testing combined with echocardiography echo-CPET at 12 weeks Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled A sample size estimation alfa 005 power 80 a 20 loss rate and at least a delta change of mean peakVO2 24 mLkgmin SD2 of 26 patients 13 per arm would be necessary to test our hypothesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None