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
Abstract Background Regular physical activity is recommended for patients with chronic heart failure to improve their functional capacity, and walking is a popular, effective, and safe form of physical activity. Pedometers have shown potential to increase the amount of walking across a range of chro...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-07-01
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| Series: | Journal of Translational Medicine |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12967-017-1257-x |
| _version_ | 1817988221804478464 |
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| author | Tomas Vetrovsky Michal Siranec Jiri Parenica Martin Griva Jiri Stastny Jan Precek Radek Pelouch Vaclav Bunc Ales Linhart Jan Belohlavek |
| author_facet | Tomas Vetrovsky Michal Siranec Jiri Parenica Martin Griva Jiri Stastny Jan Precek Radek Pelouch Vaclav Bunc Ales Linhart Jan Belohlavek |
| author_sort | Tomas Vetrovsky |
| collection | DOAJ |
| description | Abstract Background Regular physical activity is recommended for patients with chronic heart failure to improve their functional capacity, and walking is a popular, effective, and safe form of physical activity. Pedometers have shown potential to increase the amount of walking across a range of chronic diseases, but it is unknown whether a pedometer-based intervention improves functional capacity and neurohumoral modulation in heart failure patients. Methods Two multicenter randomized controlled trials will be conducted in parallel: one in patients with chronic heart failure with reduced ejection fraction (HFrEF), the other in patients with chronic heart failure with preserved ejection fraction (HFpEF). Each trial will consist of a 6-month intervention with an assessment at baseline, at 3 months, at the end of the intervention, and 6 months after completing the intervention. Each trial will aim to include a total of 200 physically inactive participants with chronic heart failure who will be randomly assigned to intervention or control arms. The 6-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a 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-min walk distance at the end of the 6-month intervention. 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. Discussion To our knowledge, these are the first studies to evaluate a pedometer-based walking intervention in patients with chronic heart failure with either reduced or preserved ejection fraction. The studies will contribute to a better understanding of physical activity promotion in heart failure patients to inform future physical activity recommendations and heart failure guidelines. Trial registration The trials are registered in ClinicalTrials.gov, identifiers: NCT03041610, registered 29 January 2017 (HFrEF), NCT03041376, registered 1 February 2017 (HFpEF) |
| first_indexed | 2024-04-14T00:31:32Z |
| format | Article |
| id | doaj.art-eb9abed1a55e456cb441f2a1fb5acb4c |
| institution | Directory Open Access Journal |
| issn | 1479-5876 |
| language | English |
| last_indexed | 2024-04-14T00:31:32Z |
| publishDate | 2017-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Translational Medicine |
| spelling | doaj.art-eb9abed1a55e456cb441f2a1fb5acb4c2022-12-22T02:22:32ZengBMCJournal of Translational Medicine1479-58762017-07-0115111010.1186/s12967-017-1257-xEffect 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 trialsTomas Vetrovsky0Michal Siranec1Jiri Parenica2Martin Griva3Jiri Stastny4Jan Precek5Radek Pelouch6Vaclav Bunc7Ales Linhart8Jan Belohlavek9Faculty of Physical Education and Sport, Charles University2nd Department of Medicine-Department of Cardiovascular Medicine, 1st Faculty of Medicine, Charles University in Prague and General University Hospital in PragueCardiology Department of University Hospital BrnoDepartment of Cardiology, Tomas Bata Regional Hospital, ZlinDepartment of Cardiology, Tomas Bata Regional Hospital, ZlinDepartment of Internal Medicine I-Cardiology, University Hospital Olomouc1st Department of Internal Medicine - Cardioangiology, Charles University in Prague - Faculty of Medicine in Hradec Kralove, University Hospital Hradec KraloveFaculty of Physical Education and Sport, Charles University2nd Department of Medicine-Department of Cardiovascular Medicine, 1st Faculty of Medicine, Charles University in Prague and General University Hospital in Prague2nd Department of Medicine-Department of Cardiovascular Medicine, 1st Faculty of Medicine, Charles University in Prague and General University Hospital in PragueAbstract Background Regular physical activity is recommended for patients with chronic heart failure to improve their functional capacity, and walking is a popular, effective, and safe form of physical activity. Pedometers have shown potential to increase the amount of walking across a range of chronic diseases, but it is unknown whether a pedometer-based intervention improves functional capacity and neurohumoral modulation in heart failure patients. Methods Two multicenter randomized controlled trials will be conducted in parallel: one in patients with chronic heart failure with reduced ejection fraction (HFrEF), the other in patients with chronic heart failure with preserved ejection fraction (HFpEF). Each trial will consist of a 6-month intervention with an assessment at baseline, at 3 months, at the end of the intervention, and 6 months after completing the intervention. Each trial will aim to include a total of 200 physically inactive participants with chronic heart failure who will be randomly assigned to intervention or control arms. The 6-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a 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-min walk distance at the end of the 6-month intervention. 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. Discussion To our knowledge, these are the first studies to evaluate a pedometer-based walking intervention in patients with chronic heart failure with either reduced or preserved ejection fraction. The studies will contribute to a better understanding of physical activity promotion in heart failure patients to inform future physical activity recommendations and heart failure guidelines. Trial registration The trials are registered in ClinicalTrials.gov, identifiers: NCT03041610, registered 29 January 2017 (HFrEF), NCT03041376, registered 1 February 2017 (HFpEF)http://link.springer.com/article/10.1186/s12967-017-1257-xChronic heart failurePhysical activityWalkingFunctional capacityPedometer6-min walk test |
| spellingShingle | Tomas Vetrovsky Michal Siranec Jiri Parenica Martin Griva Jiri Stastny Jan Precek Radek Pelouch Vaclav Bunc Ales Linhart Jan Belohlavek 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 Journal of Translational Medicine Chronic heart failure Physical activity Walking Functional capacity Pedometer 6-min walk test |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Chronic heart failure Physical activity Walking Functional capacity Pedometer 6-min walk test |
| url | http://link.springer.com/article/10.1186/s12967-017-1257-x |
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