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

NCT03041376 | Unknown

• 1 other identifier: Walking in HFpEF
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diastolic 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

Study Arms (2)

Walking intervention

EXPERIMENTAL

Behavioral: Walking intervention

Control

NO INTERVENTION

Interventions

Walking intervention BEHAVIORAL

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• the presence of symptoms and/or signs of heart failure,
• left ventricular ejection fraction ≥50% (HFpEF) or 40-49% (HFmrEF),
• elevated levels of natriuretic peptides (BNP \>35 pg/ml and/or NT-proBNP \>125 pg/mL),
• objective evidence of other cardiac functional and structural alterations underlying heart failure.
• 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.

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• General University Hospital, Prague: collaborator
• Brno University Hospital: collaborator
• University Hospital Olomouc: collaborator
• University Hospital Hradec Kralove: collaborator
• Tomas Bata Hospital, Czech Republic: collaborator

Study Sites (1)

General University Hospital in Prague

Prague, 12808, Czechia

RECRUITING

Related Publications (1)

• 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: 28673328 DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Jan Belohlavek, Ass. Prof.

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Belohlavek, Ass. Prof.

CONTACT

+420724371594; Jan.Belohlavek@vfn.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 2, 2017
• Study Start: April 11, 2017
• Primary Completion: June 30, 2019
• Study Completion: January 31, 2020
• Last Updated: May 17, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)