Heart Failure and Promotion of Physical Activity before and after Cardiac reHabilitation

Rationale: Heart failure is a severe chronic disease with a great health care burden. Frequent (re-)hospitalizations and a high mortality remain an important issue. Optimal medical therapy (OMT) and lifestyle changes such as increased physical activity (PA) are the cornerstones of treatment. Based on the European Society for Cardiology (ESC) guidelines, regular aerobic exercise, for example within a centre-based cardiac rehabilitation (CR) is recommended for all Heart Failure patients with reduced Ejection Fraction (HFrEF) patients. Several studies have shown that PA is just as effective as medical therapy and can lower hospital admissions and decrease mortality. However, physical activity in this group of patients is challenging as both low participation rates for CR and relapse to low physical activity levels after CR are major issues. This study aims to demonstrate that monitoring physical activity in combination with motivational feedback benefits the level of participation in centre-based CR and, hence, the outcomes for these HF patients.
Objective: To investigate in our defined HF patient population if monitoring in combination with motivation on physical activity leads to an increase in enrollment rate for cardiac rehabilitation and sustained physical activity after cardiac rehabilitation as measured by the 6MWT.
Study design: The proposed study is a randomized controlled trial with a follow-up of at least 6 months. A total of 180 patients will be randomized to 2 arms in a 2:1 fashion: (1) Physical activity monitoring device with feedback and motivation; (2) Physical activity monitoring device without feedback and motivation. Both arms will have standard of care (SoC), including standard cardiac rehabilitation (specific for HF) according to the Dutch guidelines along with OMT as prescribed by the treating physician. The enrolment period will be 12 months. Additional measurements will take place at 3 time points: at baseline (within 6 weeks after inclusion), at the end of CR (16-20 weeks after inclusion) and at the end of follow-up (3 months after CR or at least 6 months after inclusion).
Study population: Patients aged 18-85 years with chronic HFrEF (NYHA class II and III) who have a clinically stable condition, an indication for physical exercise and CR, will be eligible to participate in this study. All included patients are required to have provided written informed consent.
Intervention: All patients in both arms of the study will wear an Actigraph activity tracker for physical activity monitoring. In addition, only the intervention arm will also wear a Fitbit smartwatch on which they will receive automated motivational feedback based on a goal for physical activity (step count), set by the treating physician before and after CR.

We hypothesize that physical activity (PA) monitoring with motivational feedback (using an activity tracker) before and after centre-based CR in patients with HFrEF (NYHA class II/III) will lead to a clinically meaningful increase in the 6MWT. Contributing factors to this objective are an expected improved participation rate in CR and a maintained PA after CR.

• T0: At inclusion.
• T1: At completion* of CR, or for patients who did not start or did not complete CR, this will be at 16-20 weeks after inclusion.
• T2: 3 months after completion of CR, or for patients who did not start or did not complete CR, this will be 7 months after inclusion.

The intervention arm will be stimulated to become more active. This will be achieved through visualization of step count on the Fitbit smartwatch and mobile phone and by receiving feedback on daily step count goals on the Fitbit smartwatch and mobile phone.