A Physical Activity Program for People With Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical Activity.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Step-Based Physical Activity Intervention in Patients With Heart Failure: The STEP-IN Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral 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
Primary outcome measures
- Change in functional capacity [Time frame: Baseline, 3 months, 9 months and 12 months]
Secondary outcome measures (7)
- Change in patient-perceived heart failure-related symptoms and limitations [Time frame: Baseline, 3 months, 9 months and 12 months]
- Change in systemic inflammation [Time frame: Baseline and 9 months]
- Change in additional pro- and anti-inflammatory markers [Time frame: Baseline and 9 months]
- Change in counts of steps [Time frame: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months]
- Change in time spent at light, moderate and vigorous-intensity step cadence [Time frame: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months]
- Change in peak cadence [Time frame: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months]
- Change in 24-hour movement behaviors [Time frame: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Spain · 4 centers
- Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health U — Granada
- Hospital Universitario Clínico San Cecilio — Granada
- Hospital Universitario Virgen de las Nieves — Granada
- Hospital Comarcal Santa Ana de Motril — Motril
Identifiers
NCT: NCT07204834 · SPID202300X148404IV0