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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
The intervention will be delivered over a six-month period and will consist of: (1) an individualized pedometer-based walking program with weekly step goals, (2) regular visits to the clinic including face-to-face session with the physician, and (3) regular telephone calls with the research nurse in between the face-to-face contacts.
General University Hospital in Prague
Prague, Czechia
RECRUITINGfunctional capacity
functional capacity change measured with 6-minute walk test
Time frame: 6 months
functional capacity
functional capacity change measured with 6-minute walk test
Time frame: 12 months
NT-proBNP
N-terminal pro-B-type natriuretic peptide levels
Time frame: 6 months
hsCRP
high-sensitivity C-reactive protein
Time frame: 6 months
pulmonary congestion
assessed by ultrasound detection of B-lines
Time frame: 6 and 12 months
physical activity
average daily step count measured over 7 days by ActiGraph
Time frame: 6 and 12 months
depression
assessed with the Beck Depression Inventory-II
Time frame: 6 and 12 months
health-related quality of life
assessed with the 36-Item Short Form Health Survey (SF-36)
Time frame: 6 and 12 months
self-efficacy
assessed with the Czech version of the General Self-Efficacy scale (DOVE)
Time frame: 6 and 12 months
body mass index
calculated by dividing the body weight (kg) by the square of the height (m2)
Time frame: 6 and 12 months
waist circumference
recorded with a measurement tape to the nearest 0.1 cm
Time frame: 6 and 12 months
hip circumference
recorded with a measurement tape to the nearest 0.1 cm
Time frame: 6 and 12 months
Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score
method to predict survival in heart failure patients
Time frame: 6 and 12 months
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