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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diastolic Heart Failure
• Intervention / Treatment: Behavioral: Walking intervention

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Belohlavek, Ass. Prof.; Phone Number: +420724371594; Email: Jan.Belohlavek@vfn.cz

Study Locations

• Czechia
  • Prague, Czechia, 12808
    • Recruiting
    • General University Hospital in Prague
    • Contact: Jan Belohlavek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional capacity	functional capacity change measured with 6-minute walk test	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: Brno University Hospital; University Hospital Olomouc; Tomas Bata Hospital, Czech Republic; General University Hospital, Prague; University Hospital Hradec Kralove
• Investigators: Principal Investigator: Jan Belohlavek, Ass. Prof., Charles University, Czech Republic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): January 31, 2020

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Diastolic
• Other Study ID Numbers: Walking in HFpEF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No