Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426173
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-29
Brief Title:
Effect of Resistance Training in Patients on the Waiting List for Heart Transplant
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Effect of Resistance Training on Functional Capacity Quality of Life and Cardiac Biomarkers in Patients on the Waiting List for Heart Transplant a Randomized and Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The present longitudinal randomized and blinded clinical trial aims to
Evaluate the effects of resistance training on the functional capacity quality of life and cardiac biomarkers of hospitalized patients with heart failure HF on the waiting list for heart transplantation HTx
Evaluate the associations between Frieds frailty classification and functional capacity responses to resistance training
The protocol will have a total duration of 12 weeks
Evaluate the effects of resistance training on the functional capacity quality of life and cardiac biomarkers of hospitalized patients with heart failure HF on the waiting list for heart transplantation HTx
Evaluate the associations between Frieds frailty classification and functional capacity responses to resistance training
The protocol will have a total duration of 12 weeks
Detailed Description:
Heart failure HF presents a significant challenge to contemporary healthcare systems As HF progresses heart transplantation HTx becomes the primary treatment option to enhance survival rates Patients awaiting HTx often endure extended hospitalizations and rely on continuous inotropic support This scenario exacerbates bed rest and potentially worsening functional capacity Resistance training has shown promise in mitigating the detrimental effects of immobility however limited research has explored its impact on HF patients on the HTx waiting list
Objectives
To evaluate the effects of resistance training on functional capacity quality of life and cardiac biomarkers in hospitalized patients with HF on the HTx waiting list
To assess the associations between Frieds frailty phenotype and functional capacity responses to resistance training hemodynamic behavior during the protocol and the incidence of adverse events during the protocol implementation
Methods
A total of 50 patients hospitalized on the HTx waiting list will be recruited for this study Participants will be randomly assigned to one of two groups the resistance training group TG and the control group CG Assessments will occur at three time points baseline T0 at 6 weeks T1 and at 12 weeks T2 of resistance training Clinical parameters will be evaluated including the six-minute walk test and the Short Physical Performance Battery Peripheral muscle strength will be measured using a dynamometer and inspiratory muscle strength will be assessed through maximum inspiratory pressure Quality of life will be evaluated using the Kansas City Cardiomyopathy Questionnaire-12 Additionally cardiac biomarkers such as exhaled air ketone and brain natriuretic peptide levels in venous blood samples will be analyzed
Objectives
To evaluate the effects of resistance training on functional capacity quality of life and cardiac biomarkers in hospitalized patients with HF on the HTx waiting list
To assess the associations between Frieds frailty phenotype and functional capacity responses to resistance training hemodynamic behavior during the protocol and the incidence of adverse events during the protocol implementation
Methods
A total of 50 patients hospitalized on the HTx waiting list will be recruited for this study Participants will be randomly assigned to one of two groups the resistance training group TG and the control group CG Assessments will occur at three time points baseline T0 at 6 weeks T1 and at 12 weeks T2 of resistance training Clinical parameters will be evaluated including the six-minute walk test and the Short Physical Performance Battery Peripheral muscle strength will be measured using a dynamometer and inspiratory muscle strength will be assessed through maximum inspiratory pressure Quality of life will be evaluated using the Kansas City Cardiomyopathy Questionnaire-12 Additionally cardiac biomarkers such as exhaled air ketone and brain natriuretic peptide levels in venous blood samples will be analyzed
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