Cognitive impairment, frailty and rehabilitation outcome in older cardiorespiratory patients. DEC_FRAinRIAB: Study protocol.

Background: Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) are two clinical conditions often associated with functional worsening, cognitive dysfunctions, treatment non-adherence, psychological distress and poor quality of life (QoL). In addition, since patients suffering from these conditions are often older adults, the presence of frailty syndrome could worsen the clinical situation.

Methods And Design: This study protocol of a prospective multi-center clinical trial, will be conducted at two hospitals of the Istituti Clinici Scientifici Maugeri IRCCS group, from July 2020 until December 2022. CHF and COPD older patients (age ≥65) will undergo a multidisciplinary assessment at admission, discharge and at 6 months follow-up, from an inpatient rehabilitation program: disease-related clinical characteristics, functional variables, cognitive screening, treatment adherence, anxiety, depression, QoL and frailty. The estimated sample size will consist of 300 patients.

Discussion: The expected results are related to the possibility of an improvement in the areas of intervention after the rehabilitative program and the maintenance of these improvements over time. The assessment of clinical and functional status, cognitive impairment, treatment adherence, psychosocial characteristics, and frailty could provide more specific and useful information about the main features to be considered in the evaluation and treatment of older patients suffering from CHF and COPD undergoing a rehabilitative pathway.

Trial Registration: The study has been registered on January 28, 2022 with the ClinicalTrials.gov NCT05230927 registration number (clinicaltrials.gov/ct2/show/NCT05230927).