Cognitive Impairment, Frailty and Rehabilitative Outcome in Older Patients Affected by Cardiorespiratory Disease

NCT ID: NCT05230927

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-21
• Study Completion Date: 2022-12-23

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).

Conditions

Chronic Heart Failure; Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Chronic Heart Failure

Multidisciplinary Rehabilitation

Intervention Type: OTHER

All patients admitted to an inpatient rehabilitation program will undergo medical history collection, physical, clinical, and functional examination, exercise testing, educational sessions, exercise training (cycle ergometer/treadmill, arm ergometer, breathing, and strength exercises where indicated, calisthenics exercises), psychological counseling, and metabolic evaluation with a personalized diet when needed.

Chronic Obstructive Pulmonary Disease

Multidisciplinary Rehabilitation

Intervention Type: OTHER

All patients admitted to an inpatient rehabilitation program will undergo medical history collection, physical, clinical, and functional examination, exercise testing, educational sessions, exercise training (cycle ergometer/treadmill, arm ergometer, breathing, and strength exercises where indicated, calisthenics exercises), psychological counseling, and metabolic evaluation with a personalized diet when needed.

Interventions

Multidisciplinary Rehabilitation

All patients admitted to an inpatient rehabilitation program will undergo medical history collection, physical, clinical, and functional examination, exercise testing, educational sessions, exercise training (cycle ergometer/treadmill, arm ergometer, breathing, and strength exercises where indicated, calisthenics exercises), psychological counseling, and metabolic evaluation with a personalized diet when needed.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antonia Pierobon

OTHER

Sponsor Role: lead

Responsible Party

Antonia Pierobon

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Istituti Clinici Scientifici Maugeri, IRCCS

Pavia, PV, Italy

Countries

Italy

References

Vigore M, Granata N, Callegari G, Vaninetti R, Conti S, Maestri R, Piaggi G, Cremonese G, Pierobon A. Frailty and rehabilitation outcome in older patients with cardiorespiratory disease: preliminary multidimensional data. Monaldi Arch Chest Dis. 2022 Dec 1;93(4). doi: 10.4081/monaldi.2022.2447.

Reference Type: DERIVED

PMID: 36458416 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35925981 (View on PubMed)

Other Identifiers

2424

Identifier Type: -

Identifier Source: org_study_id