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| Name | Class |
|---|---|
| General University Hospital, Prague | OTHER |
| Brno University Hospital | OTHER |
| University Hospital Olomouc | OTHER |
| University Hospital Hradec Kralove |
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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.
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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:
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:
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Belohlavek, Ass. Prof. | Contact | +420724371594 | Jan.Belohlavek@vfn.cz |
| 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 | Recruiting | Prague | 12808 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Tomas Bata Hospital, Czech Republic | 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 |