Back to resultsPedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Preserved Ejection Fraction
Primary Purpose
Diastolic Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Walking intervention
Sponsored by
About this trial
This is an interventional prevention trial for Diastolic Heart Failure
Eligibility Criteria
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:
- the presence of symptoms and/or signs of heart failure,
- left ventricular ejection fraction ≥50% (HFpEF) or 40-49% (HFmrEF),
- elevated levels of natriuretic peptides (BNP >35 pg/ml and/or NT-proBNP >125 pg/mL),
- objective evidence of other cardiac functional and structural alterations underlying heart failure.
- 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:
- 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.
- 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).
- Major surgery planned within the next 12 months.
- Life expectancy shorter than 12 months.
- Inability to walk from any reason.
- 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.
- Pregnancy.
- Failure to perform the 6MWT.
Sites / Locations
- General University Hospital in PragueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Walking intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
functional capacity
functional capacity change measured with 6-minute walk test
Secondary Outcome Measures
functional capacity
functional capacity change measured with 6-minute walk test
NT-proBNP
N-terminal pro-B-type natriuretic peptide levels
hsCRP
high-sensitivity C-reactive protein
pulmonary congestion
assessed by ultrasound detection of B-lines
physical activity
average daily step count measured over 7 days by ActiGraph
depression
assessed with the Beck Depression Inventory-II
health-related quality of life
assessed with the 36-Item Short Form Health Survey (SF-36)
self-efficacy
assessed with the Czech version of the General Self-Efficacy scale (DOVE)
body mass index
calculated by dividing the body weight (kg) by the square of the height (m2)
waist circumference
recorded with a measurement tape to the nearest 0.1 cm
hip circumference
recorded with a measurement tape to the nearest 0.1 cm
Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score
method to predict survival in heart failure patients
Full Information
NCT ID
NCT03041376
First Posted
February 1, 2017
Last Updated
May 14, 2018
Sponsor
Charles University, Czech Republic
Collaborators
General University Hospital, Prague, Brno University Hospital, University Hospital Olomouc, University Hospital Hradec Kralove, Tomas Bata Hospital, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT03041376
Brief Title
Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Preserved Ejection Fraction
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
January 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
Collaborators
General University Hospital, Prague, Brno University Hospital, University Hospital Olomouc, University Hospital Hradec Kralove, Tomas Bata Hospital, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Walking intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Walking intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
functional capacity
Description
functional capacity change measured with 6-minute walk test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
functional capacity
Description
functional capacity change measured with 6-minute walk test
Time Frame
12 months
Title
NT-proBNP
Description
N-terminal pro-B-type natriuretic peptide levels
Time Frame
6 months
Title
hsCRP
Description
high-sensitivity C-reactive protein
Time Frame
6 months
Title
pulmonary congestion
Description
assessed by ultrasound detection of B-lines
Time Frame
6 and 12 months
Title
physical activity
Description
average daily step count measured over 7 days by ActiGraph
Time Frame
6 and 12 months
Title
depression
Description
assessed with the Beck Depression Inventory-II
Time Frame
6 and 12 months
Title
health-related quality of life
Description
assessed with the 36-Item Short Form Health Survey (SF-36)
Time Frame
6 and 12 months
Title
self-efficacy
Description
assessed with the Czech version of the General Self-Efficacy scale (DOVE)
Time Frame
6 and 12 months
Title
body mass index
Description
calculated by dividing the body weight (kg) by the square of the height (m2)
Time Frame
6 and 12 months
Title
waist circumference
Description
recorded with a measurement tape to the nearest 0.1 cm
Time Frame
6 and 12 months
Title
hip circumference
Description
recorded with a measurement tape to the nearest 0.1 cm
Time Frame
6 and 12 months
Title
Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score
Description
method to predict survival in heart failure patients
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
the presence of symptoms and/or signs of heart failure,
left ventricular ejection fraction ≥50% (HFpEF) or 40-49% (HFmrEF),
elevated levels of natriuretic peptides (BNP >35 pg/ml and/or NT-proBNP >125 pg/mL),
objective evidence of other cardiac functional and structural alterations underlying heart failure.
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:
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.
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).
Major surgery planned within the next 12 months.
Life expectancy shorter than 12 months.
Inability to walk from any reason.
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.
Pregnancy.
Failure to perform the 6MWT.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Belohlavek, Ass. Prof.
Phone
+420724371594
Email
Jan.Belohlavek@vfn.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Belohlavek, Ass. Prof.
Organizational Affiliation
Charles University, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
General University Hospital in Prague
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Belohlavek
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28673328
Citation
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.
Results Reference
derived
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Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Preserved Ejection Fraction
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