NCT07204834Enrolling by invitation
A Physical Activity Program for People With Heart Failure
A Step-Based Physical Activity Intervention in Patients With Heart Failure: The STEP-IN Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 12 Sept 2025
- Start date
- 8 Oct 2025
- Primary completion date
- Sept 2028
- Lead sponsor
- Universidad de Granada
- Diseases
- Heart failure
- NCT number
- NCT07204834
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 8 Oct 2025 to the primary completion date, Sept 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Comarcal Santa Ana de Motril Coordinator of this site? Confirm its status | Motril | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.