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Systolic Heart FailureNCT03041610

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

A study testing Walking intervention in people with Systolic Heart Failure, run by Charles University, Czech Republic at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systolic Heart Failure
What is being tested?
Walking intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
1 siteCzechia
Study dates
1 Aug 2018to 30 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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?".

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Czechia1 site

  • General University Hospital in Prague

    Prague, 12808

Other trials in Czechia

About this study

Official title: Effect of Pedometer-Based Walking Intervention on Functional Capacity and Neurohumoral Modulation in Patients With Chronic Heart Failure With Reduced 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 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.

Being tested
Walking intervention
Medical subject headings
Heart Failure, Systolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Walking interventionBehavioural

    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.

Study groups in NCT03041610
Study groupRoleWhat they receive
Walking interventionExperimentalNot described
Receives: Behavioral: Walking intervention
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. functional capacity

    functional capacity change measured with 6-minute walk test

    Measured: 6 months

Secondary outcomes (12)

  1. functional capacity

    functional capacity change measured with 6-minute walk test

    Measured: 12 months

  2. NT-proBNP

    N-terminal pro-B-type natriuretic peptide levels

    Measured: 6 months

  3. hsCRP

    high-sensitivity C-reactive protein

    Measured: 6 months

  4. pulmonary congestion

    assessed by ultrasound detection of B-lines

    Measured: 6 and 12 months

  5. physical activity

    average daily step count measured over 7 days by ActiGraph

    Measured: 6 and 12 months

  6. depression

    assessed with the Beck Depression Inventory-II

    Measured: 6 and 12 months

  7. health-related quality of life

    assessed with the 36-Item Short Form Health Survey (SF-36)

    Measured: 6 and 12 months

  8. self-efficacy

    assessed with the Czech version of the General Self-Efficacy scale (DOVE)

    Measured: 6 and 12 months

  9. body mass index

    calculated by dividing the body weight (kg) by the square of the height (m2).

    Measured: 6 and 12 months

  10. waist circumference

    recorded with a measurement tape to the nearest 0.1 cm

    Measured: 6 and 12 months

  11. hip circumference

    recorded with a measurement tape to the nearest 0.1 cm

    Measured: 6 and 12 months

  12. Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score

    method to predict survival in heart failure patients

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2017 (estimated)
  2. Study start1 Aug 2018
  3. Primary completion30 Jun 2023
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03041610
Sponsor's protocol ID
Walking in HFrEF
Status last verified
Oct 2023
First submitted
29 Jan 2017
Last updated
4 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37955615

  • 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.

    PubMed 37587489

  • 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.

    PubMed 28673328

Questions about this trial

What is this clinical trial studying?

A study testing Walking intervention in people with Systolic Heart Failure, run by Charles University, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

functional capacity (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03041610, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.

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