NCT03041610

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

4.9 years

First QC Date

January 29, 2017

Last Update Submit

October 1, 2023

Conditions

Systolic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • functional capacity

    functional capacity change measured with 6-minute walk test

    6 months

Secondary Outcomes (12)

  • functional capacity

    12 months

  • NT-proBNP

    6 months

  • hsCRP

    6 months

  • pulmonary congestion

    6 and 12 months

  • physical activity

    6 and 12 months

  • +7 more secondary outcomes

Study Arms (2)

Walking intervention

EXPERIMENTAL
Behavioral: Walking intervention

Control

NO INTERVENTION

Interventions

Walking interventionBEHAVIORAL

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.

Walking intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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?".

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General University Hospital in Prague

Prague, 12808, Czechia

Location

Related Publications (3)

  • Vetrovsky T, Siranec M, Frybova T, Gant I, Svobodova I, Linhart A, Parenica J, Miklikova M, Sujakova L, Pospisil D, Pelouch R, Odrazkova D, Parizek P, Precek J, Hutyra M, Taborsky M, Vesely J, Griva M, Semerad M, Bunc V, Hrabcova K, Vojkuvkova A, Svoboda M, Belohlavek J; WATCHFUL Investigators. Lifestyle Walking Intervention for Patients With Heart Failure With Reduced Ejection Fraction: The WATCHFUL Trial. Circulation. 2024 Jan 16;149(3):177-188. doi: 10.1161/CIRCULATIONAHA.123.067395. Epub 2023 Nov 13.

    PMID: 37955615DERIVED

  • Vetrovsky T, Siranec M, Frybova T, Gant I, Semerad M, Miklikova M, Bunc V, Vesely J, Stastny J, Griva M, Precek J, Pelouch R, Parenica J, Jarkovsky J, Belohlavek J. Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial. Trials. 2023 Aug 17;24(1):539. doi: 10.1186/s13063-023-07516-5.

    PMID: 37587489DERIVED

  • 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.

    PMID: 28673328DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Officials

  • Jan Belohlavek, Ass. Prof.

    Charles University, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

January 29, 2017

First Posted

February 3, 2017

Study Start

August 1, 2018

Primary Completion

June 30, 2023

Study Completion

December 30, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)