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

C

Charles University, Czech Republic

Status

Active, not recruiting

Conditions

Systolic Heart Failure

Treatments

Behavioral: Walking intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03041610
Walking in HFrEF

Details and patient eligibility

About

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.

Enrollment

202 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

202 participants in 2 patient groups

Walking intervention
Experimental group
Treatment:
Behavioral: Walking intervention
Control
No Intervention group

Trial contacts and locations

0

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Central trial contact

Jan Belohlavek, Ass. Prof.

Data sourced from clinicaltrials.gov

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