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Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Reduced Ejection Fraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041610
Recruitment Status : Unknown
Verified May 2018 by Jan Belohlavek, Charles University, Czech Republic.
Recruitment status was:  Recruiting
First Posted : February 3, 2017
Last Update Posted : May 17, 2018
Sponsor:
Collaborators:
University Hospital Hradec Kralove
University Hospital Olomouc
Tomas Bata Hospital, Czech Republic
Brno University Hospital
General University Hospital, Prague
Information provided by (Responsible Party):
Jan Belohlavek, Charles University, Czech Republic

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
Systolic Heart Failure Behavioral: Walking intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Pedometer-Based Walking Intervention on Functional Capacity and Neurohumoral Modulation in Patients With Chronic Heart Failure With Reduced 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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



Primary Outcome Measures :
  1. functional capacity [ Time Frame: 6 months ]
    functional capacity change measured with 6-minute walk test


Secondary Outcome Measures :
  1. functional capacity [ Time Frame: 12 months ]
    functional capacity change measured with 6-minute walk test

  2. NT-proBNP [ Time Frame: 6 months ]
    N-terminal pro-B-type natriuretic peptide levels

  3. hsCRP [ Time Frame: 6 months ]
    high-sensitivity C-reactive protein

  4. pulmonary congestion [ Time Frame: 6 and 12 months ]
    assessed by ultrasound detection of B-lines

  5. physical activity [ Time Frame: 6 and 12 months ]
    average daily step count measured over 7 days by ActiGraph

  6. depression [ Time Frame: 6 and 12 months ]
    assessed with the Beck Depression Inventory-II

  7. health-related quality of life [ Time Frame: 6 and 12 months ]
    assessed with the 36-Item Short Form Health Survey (SF-36)

  8. self-efficacy [ Time Frame: 6 and 12 months ]
    assessed with the Czech version of the General Self-Efficacy scale (DOVE)

  9. body mass index [ Time Frame: 6 and 12 months ]
    calculated by dividing the body weight (kg) by the square of the height (m2).

  10. waist circumference [ Time Frame: 6 and 12 months ]
    recorded with a measurement tape to the nearest 0.1 cm

  11. hip circumference [ Time Frame: 6 and 12 months ]
    recorded with a measurement tape to the nearest 0.1 cm

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of heart failure with reduced ejection fraction (left ventricular ejection fraction <40%) with New York Heart Association (NYHA) class II or III symptoms.
  2. 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:

  1. 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.
  2. 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).
  3. Major surgery planned within the next 12 months.
  4. Life expectancy shorter than 12 months.
  5. Inability to walk from any reason.
  6. 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.
  7. Pregnancy.
  8. Failure to perform the 6MWT.

Information from the National Library of Medicine

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): NCT03041610


Contacts
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Contact: Jan Belohlavek, Ass. Prof. +420724371594 Jan.Belohlavek@vfn.cz

Locations
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Czechia
General University Hospital in Prague Recruiting
Prague, Czechia, 12808
Contact: Jan Belohlavek         
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
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Principal Investigator: Jan Belohlavek, Ass. Prof. Charles University, Czech Republic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jan Belohlavek, Ass. Prof., Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT03041610    
Other Study ID Numbers: Walking in HFrEF
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases