Status:
ENROLLING_BY_INVITATION
A Physical Activity Program for People With Heart Failure
Lead Sponsor:
Universidad de Granada
Collaborating Sponsors:
Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Spain
University Hospital Virgen de las Nieves
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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,...
Detailed Description
Heart failure is associated with disabling symptoms of dyspnea, fatigue, low exercise tolerance, and frequent hospitalizations. Managing heart failure is challenging, as it often coexists with several...
Eligibility Criteria
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)
- Severe symptomatic aortic stenosis
- Persistent symptomatic hypotension
- 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
- Inability to walk independently (i.e., requires assistive devices for ambulation)
- 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
- 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)
Key Trial Info
Start Date :
October 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07204834
Start Date
October 8 2025
End Date
December 1 2028
Last Update
November 18 2025
Active Locations (4)
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1
Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada
Granada, Spain, 18016
2
Hospital Universitario Clínico San Cecilio
Granada, Spain
3
Hospital Universitario Virgen de las Nieves
Granada, Spain
4
Hospital Comarcal Santa Ana de Motril
Motril, Spain