Simple, safe and effective comprehensive home-based rehabilitation program in heart failure patients - an interventional pilot study.

Abstract

Abstract Background: Rehabilitation plays an important role in the management of patients with chronic heart failure (CHF). An optimal rehabilitation model for CHF patients consisting of exercise training, breathing exercises and inspiratory muscle training has not yet been established. This prospective interventional pilot study assessed the safety and effectiveness of a 6-month home-based caregiver-supervised rehabilitation program among CHF patients. Methods: Analysis included a total of 54 CHF patients randomized into two groups: intervention group (28 patients), subjected to a 6-month home-based physical training and respiratory rehabilitation program and control group (26 patients) not included in rehabilitation program. The reference group consisted of 25 healthy individuals. The measurement of 6-min walk test (6MWT), respiratory muscle strength, quality of life assessment (SF-36, Fatigue Severity Scale – FSS) were performed prior to the start of the study and after 6 months. Occurrence of adverse events and adherence to training protocol were also assessed. Results: As a result of objective problems caused by outbreak of COVID-19 pandemic, the course and final outcome of the study have differed from the original protocol, control group has not been assessed after 6 months. In the intervention group, 6 months physical training statistically significantly improved 6MWT distance by 37,86 m (p = 0.001) and respiratory muscle strength PImax by 20.21 cmH2O, PEmax by 20.75 cmH2O (p < 0.01). Statistically significant improvement was observed after the training period with the use of FSS questionnaire -0.68 (p = 0.029). Adherence to exercise protocol was on average 91.5 ± 15.3%. No serious adverse events were noted. Conclusions: The home-based rehabilitation program that includes respiratory muscle training in CHF patients is safe and effective. It improves functional parameters and diminishes the level of fatigue. Trial registration: ClinicalTrials.gov, NCT03780803. Registered 12 December 2018, https://clinicaltrials.gov/ct2/show/NCT03780803