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| Name | Class |
|---|---|
| University Hospital Hradec Kralove | OTHER |
| University Hospital Olomouc | OTHER |
| Tomas Bata Hospital, Czech Republic | OTHER |
| Brno University Hospital |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking intervention | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| functional capacity | functional capacity change measured with 6-minute walk test | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Belohlavek, Ass. Prof. | Charles University, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital in Prague | Prague | 12808 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37955615 | Derived | Vetrovsky T, Siranec M, Frybova T, Gant I, Svobodova I, Linhart A, Parenica J, Miklikova M, Sujakova L, Pospisil D, Pelouch R, Odrazkova D, Parizek P, Precek J, Hutyra M, Taborsky M, Vesely J, Griva M, Semerad M, Bunc V, Hrabcova K, Vojkuvkova A, Svoboda M, Belohlavek J; WATCHFUL Investigators. Lifestyle Walking Intervention for Patients With Heart Failure With Reduced Ejection Fraction: The WATCHFUL Trial. Circulation. 2024 Jan 16;149(3):177-188. doi: 10.1161/CIRCULATIONAHA.123.067395. Epub 2023 Nov 13. | |
| 37587489 |
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| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| General University Hospital, Prague | OTHER |
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|
| 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 |
| Derived |
| Vetrovsky T, Siranec M, Frybova T, Gant I, Semerad M, Miklikova M, Bunc V, Vesely J, Stastny J, Griva M, Precek J, Pelouch R, Parenica J, Jarkovsky J, Belohlavek J. Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial. Trials. 2023 Aug 17;24(1):539. doi: 10.1186/s13063-023-07516-5. |
| 28673328 | Derived | Vetrovsky T, Siranec M, Parenica J, Griva M, Stastny J, Precek J, Pelouch R, Bunc V, Linhart A, Belohlavek J. Effect of a 6-month pedometer-based walking intervention on functional capacity in patients with chronic heart failure with reduced (HFrEF) and with preserved (HFpEF) ejection fraction: study protocol for two multicenter randomized controlled trials. J Transl Med. 2017 Jul 3;15(1):153. doi: 10.1186/s12967-017-1257-x. |