Cardiac Rehab for Advanced Heart Failure-LVAD Candidates
- Conditions
- Heart Failure
- Interventions
- Other: Strength Training for Frailty
- Registration Number
- NCT03132441
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Candidate for a Left Ventricular Assist Device (LVAD)
- Advanced Heart Failure as determined by New York Heart Association classification III or IV
- Unable to perform physical activities required by protocol due to anatomic or musculoskeletal comorbidities
- Physical activity is contraindicated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cardiac Rehabilitation Strength Training for Frailty Strength Training for Frailty: All patients enrolled will be enrolled in 6 weeks of cardiac rehabilitation for the pilot study.
- Primary Outcome Measures
Name Time Method Change in frailty marker gait speed Baseline, 6 weeks Frailty is assessed by the strength of a participant's gait speed, measured using a commercial device.
Change in frailty marker handgrip strength Baseline, 6 weeks Frailty is assessed by the strength of a participant's handgrip, measured using a commercial device.
- Secondary Outcome Measures
Name Time Method Change in New York Heart Association (NYHA) classification Baseline, 6 weeks 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).Change in KCCQ score Baseline, 6 weeks A participant's quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaire score.
Change in Minnesota Living with Heart Failure (MLHF) score Baseline, 6 weeks A participant's quality of life assessed by Minnesota Living with Heart Failure (MLHF) questionnaire score.
Trial Locations
- Locations (1)
Mayo Clinic-Rochester
🇺🇸Rochester, Minnesota, United States