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ENROLLING BY INVITATION
NCT07204834
NA

A Physical Activity Program for People With Heart Failure

Sponsor: Universidad de Granada

View on ClinicalTrials.gov

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.

Official title: A Step-Based Physical Activity Intervention in Patients With Heart Failure: The STEP-IN Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-10-08

Completion Date

2028-12

Last Updated

2025-11-18

Healthy Volunteers

No

Conditions

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.

Locations (4)

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

Granada, Spain

Hospital Universitario Clínico San Cecilio

Granada, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital Comarcal Santa Ana de Motril

Motril, Spain