Heart Failure
Conditions
Keywords
advanced heart failure, NYHA Class III-IV, frailty, cardiac rehabilitation
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.
Interventions
OTHERStrength Training for Frailty
Cardiac Rehabilitation, abbreviated course
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single arm pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| Change in KCCQ score | Baseline, 6 weeks | A participant's quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaire score. |
Countries
United States
Outcome results
None listed