Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Preserved Ejection Fraction
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|ClinicalTrials.gov Identifier: NCT03041376|
Recruitment Status : Unknown
Verified May 2018 by Jan Belohlavek, Charles University, Czech Republic.
Recruitment status was: Recruiting
First Posted : February 2, 2017
Last Update Posted : May 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Diastolic Heart Failure||Behavioral: Walking intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 11, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||January 31, 2020|
|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|
- functional capacity [ Time Frame: 6 months ]functional capacity change measured with 6-minute walk test
- functional capacity [ Time Frame: 12 months ]functional capacity change measured with 6-minute walk test
- NT-proBNP [ Time Frame: 6 months ]N-terminal pro-B-type natriuretic peptide levels
- hsCRP [ Time Frame: 6 months ]high-sensitivity C-reactive protein
- pulmonary congestion [ Time Frame: 6 and 12 months ]assessed by ultrasound detection of B-lines
- physical activity [ Time Frame: 6 and 12 months ]average daily step count measured over 7 days by ActiGraph
- depression [ Time Frame: 6 and 12 months ]assessed with the Beck Depression Inventory-II
- health-related quality of life [ Time Frame: 6 and 12 months ]assessed with the 36-Item Short Form Health Survey (SF-36)
- self-efficacy [ Time Frame: 6 and 12 months ]assessed with the Czech version of the General Self-Efficacy scale (DOVE)
- body mass index [ Time Frame: 6 and 12 months ]calculated by dividing the body weight (kg) by the square of the height (m2)
- waist circumference [ Time Frame: 6 and 12 months ]recorded with a measurement tape to the nearest 0.1 cm
- hip circumference [ Time Frame: 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 [ Time Frame: 6 and 12 months ]method to predict survival in heart failure patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041376
|Contact: Jan Belohlavek, Ass. Prof.||+420724371594||Jan.Belohlavek@vfn.cz|
|General University Hospital in Prague||Recruiting|
|Prague, Czechia, 12808|
|Contact: Jan Belohlavek|
|Principal Investigator:||Jan Belohlavek, Ass. Prof.||Charles University, Czech Republic|