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

Diastolic Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03041376
• Other study ID #: Walking in HFpEF
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: May 2018
• Source: Charles University, Czech Republic
• Contact: Jan Belohlavek, Ass. Prof.
• Phone: +420724371594
• Email: Jan.Belohlavek[@]vfn.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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:

1. the presence of symptoms and/or signs of heart failure,

2. left ventricular ejection fraction =50% (HFpEF) or 40-49% (HFmrEF),

3. elevated levels of natriuretic peptides (BNP >35 pg/ml and/or NT-proBNP >125 pg/mL),

4. objective evidence of other cardiac functional and structural alterations underlying heart failure.

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.

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure
• Heart Failure, Diastolic

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.

Locations

Country	Name	City	State
Czechia	General University Hospital in Prague	Prague

Sponsors (6)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Brno University Hospital, General University Hospital, Prague, Tomas Bata Hospital, Czech Republic, University Hospital Hradec Kralove, University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional capacity	functional capacity change measured with 6-minute walk test	6 months
Secondary	functional capacity	functional capacity change measured with 6-minute walk test	12 months
Secondary	NT-proBNP	N-terminal pro-B-type natriuretic peptide levels	6 months
Secondary	hsCRP	high-sensitivity C-reactive protein	6 months
Secondary	pulmonary congestion	assessed by ultrasound detection of B-lines	6 and 12 months
Secondary	physical activity	average daily step count measured over 7 days by ActiGraph	6 and 12 months
Secondary	depression	assessed with the Beck Depression Inventory-II	6 and 12 months
Secondary	health-related quality of life	assessed with the 36-Item Short Form Health Survey (SF-36)	6 and 12 months
Secondary	self-efficacy	assessed with the Czech version of the General Self-Efficacy scale (DOVE)	6 and 12 months
Secondary	body mass index	calculated by dividing the body weight (kg) by the square of the height (m2)	6 and 12 months
Secondary	waist circumference	recorded with a measurement tape to the nearest 0.1 cm	6 and 12 months
Secondary	hip circumference	recorded with a measurement tape to the nearest 0.1 cm	6 and 12 months
Secondary	Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score	method to predict survival in heart failure patients	6 and 12 months