Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Preserved Ejection Fraction

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diastolic Heart Failure

Intervention / Treatment
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* Behavioral: Walking intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of heart failure with preserved (HFpEF) or mid-range (HFmrEF) ejection fraction with New York Heart Association (NYHA) class II or III symptoms. The diagnosis requires the following conditions to be fulfilled: the presence of symptoms and/or signs of heart failure, left ventricular ejection fraction ≥50% (HFpEF) or 40-49% (HFmrEF), elevated levels of natriuretic peptides (BNP >35 pg/ml and/or NT-proBNP >125 pg/mL), objective evidence of other cardiac functional and structural alterations underlying heart failure. Physically inactive, as determined by a question As a rule, do you do at least half an hour of moderate or vigorous exercise (such as walking or a sport) on five or more days of the week?. Exclusion Criteria: Signs and symptoms of decompensated heart failure, uncontrolled arrhythmia or effort angina, severe or symptomatic aortic stenosis, persistent hypotension, recent shocks delivered by the automated implantable cardioverter defibrillator. Co-morbid conditions that would affect adherence to trial procedures (e.g. inflammatory arthritis, active malignancy, renal disease requiring dialysis, uncontrolled diabetes, major depression or other significant psychiatric disorders, cognitive impairment, significant hearing or visual impairment). Major surgery planned within the next 12 months. Life expectancy shorter than 12 months. Inability to walk from any reason. Baseline six-minute walking distance >450 meters. Patients covering more than 450 meters in the baseline six-minute walk test (6MWT) are excluded due to a possible ceiling effect. Pregnancy. Failure to perform the 6MWT.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking intervention<br> | Behavioral: Walking intervention<br>* 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional capacity | functional capacity change measured with 6-minute walk test | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional capacity | functional capacity change measured with 6-minute walk test | 12 months | 
| NT-proBNP | N-terminal pro-B-type natriuretic peptide levels | 6 months | 
| hsCRP | high-sensitivity C-reactive protein | 6 months | 
| pulmonary congestion | assessed by ultrasound detection of B-lines | 6 and 12 months | 
| physical activity | average daily step count measured over 7 days by ActiGraph | 6 and 12 months | 
| depression | assessed with the Beck Depression Inventory-II | 6 and 12 months | 
| health-related quality of life | assessed with the 36-Item Short Form Health Survey (SF-36) | 6 and 12 months | 
| self-efficacy | assessed with the Czech version of the General Self-Efficacy scale (DOVE) | 6 and 12 months | 
| body mass index | calculated by dividing the body weight (kg) by the square of the height (m2) | 6 and 12 months | 
| waist circumference | recorded with a measurement tape to the nearest 0.1 cm | 6 and 12 months | 
| hip circumference | recorded with a measurement tape to the nearest 0.1 cm | 6 and 12 months | 
| Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score | method to predict survival in heart failure patients | 6 and 12 months |