Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Study Details
Study Description
Brief Summary
A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically inactive participants with chronic heart failure with reduced 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Walking intervention
|
Behavioral: Walking intervention
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.
|
| No Intervention: Control
|
Outcome Measures
Primary Outcome Measures
- functional capacity [6 months]
functional capacity change measured with 6-minute walk test
Secondary Outcome Measures
- functional capacity [12 months]
functional capacity change measured with 6-minute walk test
- NT-proBNP [6 months]
N-terminal pro-B-type natriuretic peptide levels
- hsCRP [6 months]
high-sensitivity C-reactive protein
- pulmonary congestion [6 and 12 months]
assessed by ultrasound detection of B-lines
- physical activity [6 and 12 months]
average daily step count measured over 7 days by ActiGraph
- depression [6 and 12 months]
assessed with the Beck Depression Inventory-II
- health-related quality of life [6 and 12 months]
assessed with the 36-Item Short Form Health Survey (SF-36)
- self-efficacy [6 and 12 months]
assessed with the Czech version of the General Self-Efficacy scale (DOVE)
- body mass index [6 and 12 months]
calculated by dividing the body weight (kg) by the square of the height (m2).
- waist circumference [6 and 12 months]
recorded with a measurement tape to the nearest 0.1 cm
- hip circumference [6 and 12 months]
recorded with a measurement tape to the nearest 0.1 cm
- Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score [6 and 12 months]
method to predict survival in heart failure patients
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of heart failure with reduced ejection fraction (left ventricular ejection fraction <40%) with New York Heart Association (NYHA) class II or III symptoms.
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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:
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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.
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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).
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Major surgery planned within the next 12 months.
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Life expectancy shorter than 12 months.
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Inability to walk from any reason.
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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.
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Pregnancy.
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Failure to perform the 6MWT.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | General University Hospital in Prague | Prague | Czechia | 12808 |
Sponsors and Collaborators
- Charles University, Czech Republic
- University Hospital Hradec Kralove
- University Hospital Olomouc
- Tomas Bata Hospital, Czech Republic
- Brno University Hospital
- General University Hospital, Prague
Investigators
- Principal Investigator: Jan Belohlavek, Ass. Prof., Charles University, Czech Republic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Walking in HFrEF