Tests a daily walking program for people with heart failure
Tests a step-based exercise program in adults with heart failure.
Plain-language title generated from the registry record
Registry title: A Physical Activity Program for People With Heart Failure
Key facts
- Where
- Granada and Motril, SpainSee the 4 sites
Where in Spain
- Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of GranadaGranada, SpainNo longer taking part
- Hospital Universitario Clínico San CecilioGranada, SpainNo longer taking part
- Hospital Universitario Virgen de las NievesGranada, SpainNo longer taking part
- Hospital Comarcal Santa Ana de MotrilMotril, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universidad de Granada
- Trial code
- NCT07204834
- Record updated
- 18 November 2025
- Original description
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.Read full original descriptionShow less
A Step-Based Physical Activity Intervention in Patients With Heart Failure: The STEP-IN Randomized Controlled Trial
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.
Inclusion: Chronic heart failure with reduced ejection fraction, HFrEF, i.e., left ventricular ejection fraction ≤40%, or mildly reduced ejection fraction, HFmrEF, i.e., left ventricular ejection fraction 41-49%, confirmed with an echocardiography showing HFrEF or HFmrEF in the last 6 months and having reached stable medication titration (highest tolerated dose) for ≥1 month; Functional class New York Heart Association (NYHA) II or III, confirmed by the clinical staff; Age ≥18 years old.
Exclusion: Signs or symptoms of decompensated heart failure in the last month; Uncontrolled arrhythmia; Limiting angina (grade III or IV); In the last 3 months: myocardial infarction, revascularization procedure (i.e., percutaneous coronary intervention, coronary artery bypass graft) or insertion of a cardiac device (e.g., implantable cardioverter defibrillator, bi-ventricular pacemaker); Comorbid diagnosed conditions that either contraindicate physical activity or may adversely impact adherence to trial procedures, such as active malignancy, major depression or other significant psychiatric disorders, dementia, or significant hearing or visual impairment; Already participates in a clinical trial or plans to participate in other interventions that could affect this trial, such as cardiac rehabilitation, during the study period; Severe symptomatic aortic stenosis; Persistent symptomatic hypotension; Inability to walk independently (i.e., requires assistive devices for ambulation); Both the participant and caregiver are unable to access a smartphone or internet, or have null technology literacy (i.e., unable to use WhatsApp or a simple Web page).