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

Not Applicable

Active, not recruiting

• Conditions: Systolic Heart Failure
• Interventions: Behavioral: Walking intervention

• Registration Number: NCT03041610
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-29
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-03
• Study Start: 2018-08-01
• Primary Completion: 2023-06-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-01
• Last Update Posted: 2023-10-04
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walking intervention	Walking intervention	-

Primary Outcome Measures

Name	Time	Method
functional capacity	6 months	functional capacity change measured with 6-minute walk test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

General University Hospital in Prague; 🇨🇿 Prague, Czechia