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Clinical Trials in Spain / NCT07204834
Enrolling by invitation Not applicable

A Physical Activity Program for People With Heart Failure

NCT07204834 · tracked via the Priya Life Science Spain tracker
Sponsor
Universidad de Granada
Phase
Not applicable
Started
2025-10-08
Last updated
2025-11-18

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Physical Activity

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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)

Primary outcome measure(s)

  • Change in functional capacity — Baseline, 3 months, 9 months and 12 months
    The primary outcome is the change in functional capacity measured with a 6-minute walk test (6MWT).

Trial sites (4)

FacilityCityRegionStatus
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

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Other trials for the same condition

Personalized Therapy Study - HFRS (TriageHF) Post Approval Study Active, not recruiting
Personalized Therapy Study - Attain Stability Quad Post-Approval Study Active, not recruiting
Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY) Recruiting
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07204834 on ClinicalTrials.gov ↗ ← All trials in Spain