Cardiac Rehab for Advanced Heart Failure-LVAD Candidates

Study Overview
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Brief Summary
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This study is a pilot study evaluating the feasibility and early efficacy of cardiac rehabilitation to improve frailty and symptoms in patients with advanced heart failure (NYHA class III-IV), who are being considered for LVAD therapy.

Detailed Description
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Frailty in patients with advanced heart failure is not thoroughly described, but in those studies that assessed frailty, it was a common phenomenon. Furthermore, some data suggest an association between pre-LVAD implant frailty and post-implant complications and survival. Interventions for frailty have been utilized in various populations, including the elderly frail and the frail from cardiovascular causes. These interventions target physical strengthening and endurance and have been shown on occasion to improve functional outcomes. The current study, a pilot study, seeks to assess frailty in a prospective cohort of patients being evaluated in Heart Failure Clinic for consideration of LVAD implantation due to NYHA class III-IV dyspnea and enroll these patients in a six-week focused cardiac rehabilitation protocol aimed at improving frailty and functional independence. The primary endpoint of the study is improvement in frailty markers at the end (gait speed, handgrip strength), and secondary endpoints include improvement in the indices of quality of life and symptomatology via validated questionnaires.

Official Title
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A Prospective Trial to Evaluate the Utility of Focused Frailty Interventions on Patients Undergoing Evaluation for Left Ventricular Assist Device (LVAD) Placement

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Strength Training for Frailty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for a Left Ventricular Assist Device (LVAD) Advanced Heart Failure as determined by New York Heart Association classification III or IV Exclusion Criteria: Unable to perform physical activities required by protocol due to anatomic or musculoskeletal comorbidities Physical activity is contraindicated

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Rehabilitation<br>Strength Training for Frailty: All patients enrolled will be enrolled in 6 weeks of cardiac rehabilitation for the pilot study. | Other: Strength Training for Frailty<br>* Cardiac Rehabilitation, abbreviated course<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frailty marker handgrip strength | Frailty is assessed by the strength of a participant's handgrip, measured using a commercial device. | Baseline, 6 weeks | 
| Change in frailty marker gait speed | Frailty is assessed by the strength of a participant's gait speed, measured using a commercial device. | Baseline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in New York Heart Association (NYHA) classification | New York Heart Association (NYHA) Classification Scale Early-Stage Heart Failure NYHA Class I No symptoms at any level of exertion and no limitation in ordinary physical activity. NYHA Class II Mild symptoms and slight limitation during regular activity. Comfortable at rest. Advanced-Stage Heart Failure NYHA Class III Noticeable limitation due to symptoms, even during minimal activity. Comfortable only at rest. NYHA Class IV Severe limitations. Experience symptoms even while at rest (sitting in a recliner or watching TV). | Baseline, 6 weeks | 
| Change in Minnesota Living with Heart Failure (MLHF) score | A participant's quality of life assessed by Minnesota Living with Heart Failure (MLHF) questionnaire score. | Baseline, 6 weeks | 
| Change in KCCQ score | A participant's quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaire score. | Baseline, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced heart failure, NYHA Class III-IV, frailty, cardiac rehabilitation