Heart failure and promotion of physical activity before and after cardiac rehabilitation (HF‐aPProACH): a study protocol

Abstract

Aims Lifestyle changes, such as increasing physical activity (PA), are a cornerstone of treatment of patients with chronic heart failure (HF). However, improving PA in HF patients is challenging, and low participation rates for cardiac rehabilitation (CR) as well as relapse to low PA levels after CR are major issues. We designed a randomized controlled trial to investigate if PA monitoring with motivational feedback before and after centre-based CR in HF patients with reduced ejection fraction (HFrEF) will lead to a clinically meaningful increase in physical fitness. Methods and results A randomized controlled trial will be conducted in a sample of 180 HFrEF patients (New York Heart Association Class II/III) who are referred to 12-week standard CR. Patients will be randomized (2:1) to (1) standard of care (SoC) plus wearing a PA monitoring device (Fitbit Charge 3) with personalized step goals, feedback and motivation or (2) SoC only. The intervention lasts ±7 months: 4-5 weeks before CR, 12 weeks during CR and 12 weeks after CR. Measurements will take place at three time points. The primary endpoint is the change in the distance in 6-min walking test (6MWT) over the entire study period. Other endpoints include step count, grip strength, quality of life and all-cause mortality or hospitalization. Conclusions HF-aPProACH will provide novel information on the effectiveness of remote PA stimulation and feedback before, during and after standard CR using a commercially available device to improve physical fitness in HFrEF patients.

Telemedicine home-based management in patients with chronic heart failure and diabetes type II: study protocol for a randomized controlled trial

“…Based on the literature analyzed [ 40 , 41 ] of the experience developed over the years in patients with heart failure [ 42 ] and patients with a complex phenotype, SCC and COPD [ 19 ], followed by remote surveillance, we estimated a sample of 240 patients who could be evaluated to demonstrate efficacy on the primary outcome. The number should be sufficient to establish an anticipated difference of 45–50 m in walking distance at the 6MWT (primary endpoint) between the intervention and control group to demonstrate a statistically significant difference between groups applying a t -test with alpha = 0.80 and beta = 0.05.…”