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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
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.
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
Change in functional capacity
The primary outcome is the change in functional capacity measured with a 6-minute walk test (6MWT).
Time frame: Baseline, 3 months, 9 months and 12 months
Change in patient-perceived heart failure-related symptoms and limitations
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.
Time frame: Baseline, 3 months, 9 months and 12 months
Change in systemic inflammation
Measured with blood-based high-sensitivity C-reactive protein (hs-CRP). Unit: mg/L.
Time frame: Baseline and 9 months
Change in additional pro- and anti-inflammatory markers
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.
Time frame: Baseline and 9 months
Change in counts of steps
Measured with a StepWatch accelerometer as the total counts of steps/day.
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
Measured with a StepWatch accelerometer as minutes/day spent at light, moderate (main interest) 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
Measured with a StepWatch accelerometer as the minute with the higher number of steps.
Time frame: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months
Change in 24-hour movement behaviors
Physical activity (primary behavior of interest), sedentary, and sleep metrics measured with a Matrix Activity Monitor .
Time frame: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months
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