A Prospective Trial to Evaluate the Utility of Focused Frailty Interventions on Patients Undergoing Evaluation for Left Ventricular Assist Device (LVAD) Placement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Mayo Clinic
- Locations
- 1
- Primary Endpoint
- Change in frailty marker gait speed
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Cardiac Rehabilitation
Strength Training for Frailty:
All patients enrolled will be enrolled in 6 weeks of cardiac rehabilitation for the pilot study.
Intervention: Strength Training for Frailty (Other)
Outcomes
Primary Outcomes
Change in frailty marker gait speed
Time Frame: 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
Time Frame: Baseline, 6 weeks
Frailty is assessed by the strength of a participant's handgrip, measured using a commercial device.
Secondary Outcomes
- Change in New York Heart Association (NYHA) classification(Baseline, 6 weeks)
- Change in KCCQ score(Baseline, 6 weeks)
- Change in Minnesota Living with Heart Failure (MLHF) score(Baseline, 6 weeks)
Investigators
Sudhir Kushwaha
MD
Mayo Clinic