Cardiac Rehab for Advanced Heart Failure-LVAD Candidates

Mayo Clinic

Status: Withdrawn

Conditions: Heart Failure

Treatments: Other: Strength Training for Frailty

Study type: Interventional

Funder types: Other

Identifiers

NCT03132441

17-000210

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Cardiac Rehabilitation

Experimental group

Description:

Strength Training for Frailty: All patients enrolled will be enrolled in 6 weeks of cardiac rehabilitation for the pilot study.

Treatment:

Other: Strength Training for Frailty