A Physical Activity Program for People With Heart Failure

Summary

STEP-IN is a research study that examines the effects of a physical activity program designed to increase the daily steps and cadence of patients with heart failure, compared to standard medical care, on functional capacity and other markers related to heart and brain health.

The primary hypothesis is that participating in the physical activity program for 9 months will improve functional capacity, the primary clinical measure, significantly more than receiving only the standard medical care in people with heart failure. It is also hypothesized that the physical activity program will have positive effects on symptoms and limitations related to heart failure, inflammation, as well as heart and brain health.

Conditions

• Heart Failure

Interventions

BEHAVIORAL

Physical Activity

Participants will be encouraged to progressively increase the number of daily steps (volume) and the number of minutes per day spent at a higher cadence (intensity). To achieve these goals, the investigators will support participants in the intervention group through behavior change techniques. For example, wearable devices and an online platform will be used to monitor the behavior and track progress using simple graphs; participants will be provided with small, individualized goals which will be updated every two weeks based on the activity levels achieved the prior two weeks; standardized WhatsApp messages will be sent to prompt the behavior and face-to-face coaching sessions will be delivered throughout the intervention. Participants in this group will also receive enhanced usual care, consisting of the usual care to manage heart failure plus an education pamphlet and in-depth evaluations and reports to measure the project outcomes.

Sponsors & Collaborators

• Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Spain

  collaborator UNKNOWN

• University Hospital Virgen de las Nieves

  collaborator OTHER

• Hospital Universitario Clínico San Cecilio

  collaborator UNKNOWN

• Hospital Santa Ana de Motril

  collaborator UNKNOWN

• Mind, Brain and Behaviour Research Centre (CIMCYC)

  collaborator UNKNOWN

• Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Spain

  collaborator UNKNOWN

• Department of Medical BioSciences, Exercise Physiology ResearchGroup, Radboud University Medical Center, Nijmegen, The Netherlands

  collaborator UNKNOWN

• Instituto de Investigación Biosanitaria IBS Granada

  collaborator UNKNOWN

• Universidad de Granada

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-08

Primary Completion

2028-09-30

Completion

2028-12-31

Countries

• Spain

Study Locations