A Physical Activity Program for People With Heart Failure

Официальное название

A Step-Based Physical Activity Intervention in Patients With Heart Failure: The STEP-IN Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Change in functional capacity [Срок оценки: Baseline, 3 months, 9 months and 12 months]

Вторичные конечные точки (7)

• Change in patient-perceived heart failure-related symptoms and limitations [Срок оценки: Baseline, 3 months, 9 months and 12 months]
• Change in systemic inflammation [Срок оценки: Baseline and 9 months]
• Change in additional pro- and anti-inflammatory markers [Срок оценки: Baseline and 9 months]
• Change in counts of steps [Срок оценки: 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 [Срок оценки: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months]
• Change in peak cadence [Срок оценки: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months]
• Change in 24-hour movement behaviors [Срок оценки: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Испания · 4 центра

• 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

Идентификаторы

NCT: NCT07204834 · SPID202300X148404IV0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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