Clinical trial NCT03041376: Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Preserved Ejection Fraction
Official title: Effect of Pedometer-Based Walking Intervention on Functional Capacity and Neurohumoral Modulation in Patients With Chronic Heart Failure With Preserved Ejection Fraction: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diastolic Heart Failure
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: General University Hospital, Prague
name: Brno University Hospital
name: University Hospital Olomouc
name: University Hospital Hradec Kralove
name: Tomas Bata Hospital, Czech Republic
First posted: 2017-02-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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:

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.

Primary outcomes:
measure: functional capacity
timeFrame: 6 months
Secondary outcomes:
measure: functional capacity
timeFrame: 12 months
measure: NT-proBNP
timeFrame: 6 months
measure: hsCRP
timeFrame: 6 months
measure: pulmonary congestion
timeFrame: 6 and 12 months
measure: physical activity
timeFrame: 6 and 12 months
measure: depression
timeFrame: 6 and 12 months
measure: health-related quality of life
timeFrame: 6 and 12 months
measure: self-efficacy
timeFrame: 6 and 12 months
measure: body mass index
timeFrame: 6 and 12 months
measure: waist circumference
timeFrame: 6 and 12 months
measure: hip circumference
timeFrame: 6 and 12 months
measure: Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: General University Hospital in Prague
Study officials:
affiliation: Charles University, Czech Republic
name: Jan Belohlavek, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.