Prevalence of Frailty in Patients With a Cardiovascular Disease and Correlations With Markers of Exercise

NCT ID: NCT04206904

Last Updated: 2020-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2020-06-23

Brief Summary

In the first part of this study the prevalence of frailty in patients with cardiovascular disease will be examined. Frailty is defined as a progressive age-related decline in physiological systems that results in decreased reserves of intrinsic capacity, which confers extreme vulnerability to stressors. Patients (≥65 years, men and women) suffering from heart failure or undergoing a coronary artery bypass grafing (CABG) or percutaneous coronary intervention (PCI) will be included. Based on the phenotype of Fried, frailty will be examined in the physical domain. Moreover, the nutritional, social, psychological and cognitive domain of frailty will be examined. This will result in a total score of 0 (no frailty) to 24 (severe frailty), divided into four categories: no frailty (score 0-6), minor frailty (score 7-12), moderate frailty (score 13-18) or severe frailty (score 18-24).

Besides this frailty protocol, a few other measurements will be completed to collect additional information about the functioning of the patient.

At discharge from the hospital, some of these patients will start with a cardiac rehabilitation program. To define the exercise intensity of this program, patients will perform a maximal exercise test (CPET). In the second part of this study, correlations will be examined between markers of frailty and markers of exercise from the CPET (e.g. maximal heart rate, maximal oxygen uptake).

Conditions

Frailty

Study Design

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

Eligibility Criteria

Inclusion Criteria

Men and women with an age of at least 65 years at the start of the study; Staying in Jessa Hospital for PCI, CABG or heart failure

Exclusion Criteria

A persistently unstable clinical condition at baseline visit (angina, advanced conduction disturbances, threatening ventricular arrhythmias, acute heart failure, clinical condition requiring interventions such as acute renal failure, Hb <9,0 mg/dl, presence of end-stage disease or the lack of informed consent to study participation)

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

Sponsors

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Dominique Hansen

Principal Invesigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jessa Hospital Campus Virga Jesse

Hasselt, Limburg, Belgium

Countries

Belgium

Other Identifiers

FrCR

Identifier Type: -

Identifier Source: org_study_id