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

NCT03041376 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-05-17

No results posted yet for this 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.

Conditions

  • Diastolic Heart Failure

Interventions

BEHAVIORAL

Walking 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.

Sponsors & Collaborators

  • General University Hospital, Prague

    collaborator OTHER

  • Brno University Hospital

    collaborator OTHER

  • University Hospital Olomouc

    collaborator OTHER

  • University Hospital Hradec Kralove

    collaborator OTHER

  • Tomas Bata Hospital, Czech Republic

    collaborator OTHER

  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • Jan Belohlavek, Ass. Prof. · Charles University, Czech Republic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-11
Primary Completion
2019-06-30
Completion
2020-01-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03041376 on ClinicalTrials.gov