Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655532
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Effects of an Exercise Program in Women Over 60 yr With HFpEF and Sarcopenia on Functional Capacity and Quality of Life
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of a Concurrent Training-based Exercise Program in Women Over 60 Years With Heart Failure With Preserved Ejection Fraction and Sarcopenia on Functional Capacity Quality of Life and Cognitive Function
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-SARC
Brief Summary:
This prospective study will randomize 11 women with heart failure with preserved ejection fraction HFpEF and sarcopenia to receive standard management alone or a combined 12-week supervised exercise program combining aerobic and strength exercise carried out in a single centre
After randomization patients will be clinically evaluated The primary endpoint peakVO2 will be assessed by cardiopulmonary exercise testing CPET at 12 weeks Women over 60 with HFpEF functional class NYHA class II-III and sarcopenia criteria will be enrolled A sample size estimation alfa 005 power 80 a 20 loss rate and at least a delta change of mean peakVO2 19 mLkgmin SD2 of 40 patients 20 per arm would be necessary to test our hypothesis
After randomization patients will be clinically evaluated The primary endpoint peakVO2 will be assessed by cardiopulmonary exercise testing CPET at 12 weeks Women over 60 with HFpEF functional class NYHA class II-III and sarcopenia criteria will be enrolled A sample size estimation alfa 005 power 80 a 20 loss rate and at least a delta change of mean peakVO2 19 mLkgmin SD2 of 40 patients 20 per arm would be necessary to test our hypothesis
Detailed Description:
Heart failure with preserved ejection fraction HFpEF is a highly prevalent clinical entity that predominantly affects women whose incidence has increased in the last decade and has a complex and multifactorial pathophysiology Sarcopenia a prevalent concurrent condition appears to be associated with reduced muscle strength and reduced maximal functional capacity
Supervised training programs in patients with heart failure with reduced ejection fraction and sarcopenia have improved functional capacity However we do not have evidence about the effects of a supervised training program on patients with HFpEF and sarcopenia mainly when affecting women older than 60 This work aims to evaluate the effect of a 12-week supervised exercise program in patients with HFpEF and sarcopenia on maximal functional capacity evaluated by peak oxygen consumption peakVO2
Supervised training programs in patients with heart failure with reduced ejection fraction and sarcopenia have improved functional capacity However we do not have evidence about the effects of a supervised training program on patients with HFpEF and sarcopenia mainly when affecting women older than 60 This work aims to evaluate the effect of a 12-week supervised exercise program in patients with HFpEF and sarcopenia on maximal functional capacity evaluated by peak oxygen consumption peakVO2
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