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Status unknownNCT03041376Updated May 17, 2018

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

An interventional study of Walking intervention in Diastolic Heart Failure, sponsored by Charles University, Czech Republic. Status unknown at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-17.

Sponsored by Charles University, Czech Republic · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diastolic Heart Failure
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 200 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Charles University, Czech Republic is the lead sponsor of 220 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Walking intervention

    Behavioral: Walking intervention

  • No intervention
    Control

Interventions

  • BehavioralWalking 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.

06

What researchers measure

Primary outcomes

  1. functional capacity

    functional capacity change measured with 6-minute walk test

    Time frame: 6 months

Secondary outcomes

  1. functional capacity

    functional capacity change measured with 6-minute walk test

    Time frame: 12 months

  2. NT-proBNP

    N-terminal pro-B-type natriuretic peptide levels

    Time frame: 6 months

  3. hsCRP

    high-sensitivity C-reactive protein

    Time frame: 6 months

  4. pulmonary congestion

    assessed by ultrasound detection of B-lines

    Time frame: 6 and 12 months

  5. physical activity

    average daily step count measured over 7 days by ActiGraph

    Time frame: 6 and 12 months

  6. depression

    assessed with the Beck Depression Inventory-II

    Time frame: 6 and 12 months

  7. health-related quality of life

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

    Time frame: 6 and 12 months

  8. self-efficacy

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

    Time frame: 6 and 12 months

  9. body mass index

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

    Time frame: 6 and 12 months

  10. waist circumference

    recorded with a measurement tape to the nearest 0.1 cm

    Time frame: 6 and 12 months

  11. hip circumference

    recorded with a measurement tape to the nearest 0.1 cm

    Time frame: 6 and 12 months

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

    method to predict survival in heart failure patients

    Time frame: 6 and 12 months

07

Study locations

1 of 1 sites recruiting
  • General University Hospital in Prague
    Prague, 12808, Czechia
    • Jan Belohlavek · Contact
    Recruiting
08

References and documents

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. PubMed 28673328 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03041376
Lead sponsor
Charles University, Czech Republic
Collaborators
General University Hospital, Prague, Brno University Hospital, University Hospital Olomouc, University Hospital Hradec Kralove, Tomas Bata Hospital, Czech Republic
Responsible party
Jan Belohlavek (Ass. Prof., Charles University, Czech Republic) — Principal investigator
First posted
Feb 2, 2017
Start date
Apr 11, 2017
Primary completion
Jun 30, 2019 (estimated)
Completion
Jan 31, 2020 (estimated)
Last update
May 17, 2018

Study contacts

Jan Belohlavek, Ass. Prof.
Contact
Jan.Belohlavek@vfn.cz
+420724371594
Jan Belohlavek, Ass. Prof.
principal investigator · Charles University, Czech Republic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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