Diastolic Heart Failure Clinical Trial
Official title:
Effect of Pedometer-Based Walking Intervention on Functional Capacity and Neurohumoral Modulation in Patients With Chronic Heart Failure With Preserved Ejection Fraction: a Multicenter Randomized Controlled Trial
A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically
inactive participants with chronic heart failure with preserved or mid-range ejection
fraction will be randomly assigned to intervention or control arms.
The six-month intervention will consist of an individualized pedometer-based walking program
with weekly step goals, monthly face-to-face sessions with the physician, and monthly
telephone calls with the research nurse. The intervention will be based on effective
behavioral principles (goal setting, self-monitoring, personalized feedback).
The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes
include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound,
average daily step count measured by accelerometry, anthropometric measures, symptoms of
depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.
n/a
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