A Physical Activity Program for People With Heart Failure

Not Applicable

Not yet recruiting

• Conditions: Heart Failure

• Registration Number: NCT07204834
• Lead Sponsor: Universidad de Granada

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, 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.

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 comorbidities related to cardiovascular- and brain-health (e.g., hypertension, dyslipidemia, cognitive impairment). Physical activity programs represent a promising adjuvant to pharmacological treatments to improve patients' functional capacity, reduce their symptoms, and facilitate long-term physical activity maintenance as patients' exercise tolerance improves. However, few patients with heart failure attend and adhere to traditional structured exercise programs such as cardiac rehabilitation. In response, the overall objective of STEP-IN is to design and test the effectiveness, feasibility and safety of a real-world, individualized step-based physical activity intervention to improve functional capacity, heart failure symptoms and limitations, systemic inflammation and additional heart-brain outcomes in patients with heart failure.

STEP-IN is a two-arm, single-blind multicenter randomized controlled trial. A total of 200 adults with heart failure with reduced (≤40%) or mildly reduced ejection fraction (41-49%) and a II or III NYHA functional class will be enrolled. Participants will be randomized 1:1 to a 9-month step-based physical activity intervention or enhanced usual care. The intervention will leverage wearable devices and a personalized online platform alongside behavior change methods to progressively increase participants' daily step count (volume) and step cadence (intensity), with increments individually planned every 2 weeks. To test the effectiveness of the program all participants will undergo several evaluations at baseline, and 3, 9 and 12 months after randomization, with the main timepoint of interest being from baseline to 9-month follow-up.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study Start: 2025-10-01
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2028-09
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Change in patient-perceived heart failure-related symptoms and limitations	Baseline, 3 months, 9 months and 12 months	Measured with the Kansas City Cardiomyopathy Questionnaire - Clinical Summary Scale (KCCQ-CSS). This is scored on a 0-100 scale, with higher scores indicating better heart failure-related health status (i.e., fewer symptoms and less physical limitation); 0 reflects the worst and 100 the best status.
Change in systemic inflammation	Baseline and 9 months	Measured with blood-based high-sensitivity C-reactive protein (hs-CRP). Unit: mg/L.
Change in additional pro- and anti-inflammatory markers	Baseline and 9 months	Additional pro- and anti-inflammatory markers will be measured from a blood sample, e.g., Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α), Interleukin-1 beta (IL-1β), Interleukin-10 (IL-10), and Interleukin-1 Receptor Antagonist (IL-RA), including novel inflammatory biomarkers that may become available up to the time of analysis.; Unit: pg/mL.
Change in counts of steps	Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months	Measured with a StepWatch accelerometer as the total counts of steps/day.
Change in time spent at light, moderate and vigorous-intensity step cadence	Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months	Measured with a StepWatch accelerometer as minutes/day spent at light, moderate (main interest) and vigorous-intensity step cadence.
Change in peak cadence	Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months	Measured with a StepWatch accelerometer as the minute with the higher number of steps.
Change in 24-hour movement behaviors	Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months	Physical activity (primary behavior of interest), sedentary, and sleep metrics measured with a Matrix Activity Monitor .

Trial Locations

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