Clinical trial NCT05230927: Cognitive Impairment, Frailty and Rehabilitative Outcome in Older Patients Affected by Cardiorespiratory Disease
Official title: Cognitive Impairment, Frailty and Rehabilitative Outcome in Older Patients Affected by Cardiorespiratory Disease (DEC_FRAinRIAB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Chronic Obstructive Pulmonary Disease
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: CHF was defined as: I) signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral edema) and symptoms of HF \[New York Heart Association (NYHA) functional class II-IV\] in the presence of reduced ejection fraction (LVEF \<40%); or II) signs and symptoms of HF (e.g. elevated brain natriuretic peptides and significant structural heart disease/diastolic dysfunction) with mid-range ejection fraction (LVEF 40-49%) or preserved (LVEF ≥50%).

Patients were diagnosed according to Global initiative for chronic Obstructive Lung Disease (GOLD) criteria (Stage II-IV, C-D); they were in clinically stable condition (no exacerbations in the last 3 months) with optimized stable pharmacological therapy (inhalation therapy with long-acting anticholinergic and/or β2-agonists, inhaled corticosteroids when needed).

Brief summary: A consistent number of studies in the last few years highlighted that the functional and clinical worsening in patients with cardiac and/or respiratory disease/s increase the risk of cognitive decline.

The literature reports a greater diffusion of screening procedures for cognitive deficits in patients with cardiac diseases compared to patients with respiratory diseases. However, in both populations, the interest for cognitive impairment is justified by multiple reasons: the numerous exacerbations of the disease and re-hospitalizations, the difficulty in following complex therapeutic regimens and recognizing worsening of symptoms, the reduced functional autonomy and the rehabilitation outcome . Although recently the Italian Society of Geriatrics and Gerontology has raised the threshold for the definition of the 'elderly' patient from 65 to 75 years to better adapt to the current physical and mental performance of men and women living in economically developed countries and to the demographic situation of the Italian population. Therefore the three classes of 'elderly' patients that we will enroll will be defined as follows: "young old" (65-74 years), "old" (75-84 years), and "old-old" (≥85 years). In general, the age of the eligible sample is defined as ≥ 65 years.

Furthermore, in chronic diseases, emotional factors, such as anxiety and depression, also play an important role in disease adaptation and in the rehabilitation outcome in both cardiac and respiratory diseases.

Alongside the problems relating to emotional aspects and cognitive decline, the frailty syndrome is noteworthy, particularly in the elderly and in the presence of cardiac/respiratory diseases. Frailty is associated with the loss of functionality that leads to greater vulnerability to adverse events such as the increased risk of falls, hospitalization, institutionalization, disability and mortality.

Frailty screening or assessment scales provide predictive information on the risk of death and institutionalization and they are a good predictor of acute hospital outcomes too. Instead, concerning what emerges from international literature, in rehabilitation cardiology, despite the increase in the presence of elderly patients, the clinical and prognostic relevance of frailty has not yet been well defined and measured. On the other hand, recent studies points out that frailty is present in 1/4 of outpatient COPD patients, it is an independent predictor of rehabilitation program interruption and it is also easily reversible in the short term after rehabilitation, thus frailty appears to be one of the relevant aspects in rehabilitative treatment.

In light of the data in the literature, the purposes of this prospective observational study are to evaluate the following objectives:

1. At baseline, the presence of cognitive impairment, anxiety, depression, the assessment of self-reported adherence to therapeutic prescriptions and frailty in a sample of elderly patients (age ≥65) with chronic cardiorespiratory disease admitted for a cardiorespiratory rehabilitation cycle and the correlation with disease severity and functional aspects.
2. In follow-up, the impact that these factors have on the rehabilitation outcome at the end of hospitalization and on the state of health at six months (telephone interview).


Eligibility criteria: Inclusion Criteria:

All inpatients admitted to the Cardiac Rehabilitation Department and the Pulmonary Rehabilitation Department of ICS Maugeri - Tradate (Varese) and Montescano (Pavia) affected by CHF or COPD.

Exclusion Criteria:

* severe clinical conditions (chronic inflammatory diseases, neoplasia)
* psychiatric and neurological conditions(at anamnestic or actual clinical evaluation),
* no Italian education, illiteracy or relapse into illiteracy,
* severe visuo-perceptive deficits,
* lack of motivation or refusal to undergo the evaluation,
* severe cognitive deterioration (Mini-Mental State Examination - MMSE score \<18.3)

Primary outcomes:
measure: Changes in cognitive status
timeFrame: evaluation performed at patient's admission and before discharge (approximately 20 days)
measure: Changes in Health-related Quality of Life
timeFrame: evaluation performed at patient's admission, before discharge (approximately 20 days) and at 6 months telephone follow-up
measure: Changes in psychological characteristics
timeFrame: evaluation performed at patient's admission, before discharge (approximately 20 days) and at 6 months telephone follow-up
measure: Changes in self-reported adherence
timeFrame: evaluation performed at patient's admission, before discharge (approximately 20 days) and at 6 months telephone follow-up
measure: Frailty evaluation
timeFrame: evaluation performed at patient's admission
measure: Changes in frailty status
timeFrame: evaluation performed at patient's admission, before discharge (approximately 20 days) and at 6 months telephone follow-up
measure: Changes in functional performance of the lower extremities
timeFrame: evaluation performed at patient's admission and before discharge (approximately 20 days)
measure: Changes in mobility
timeFrame: evaluation performed at patient's admission and before discharge (approximately 20 days)
measure: Changes in functional capacity
timeFrame: evaluation performed at patient's admission and before discharge (approximately 20 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri, IRCCS
state: PV
Study officials:
References:
citation: Vigore M, Granata N, Braga SS, Piaggi G, Audifreddi S, Ferrari M, La Rovere MT, Pierobon A. Cognitive impairment, frailty and rehabilitation outcome in older cardiorespiratory patients. DEC_FRAinRIAB: Study protocol. PLoS One. 2022 Aug 4;17(8):e0272132. doi: 10.1371/journal.pone.0272132. eCollection 2022.