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

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206904
• Other study ID #: FrCR
• Status: Completed
• Start date: November 25, 2019
• Est. completion date: June 23, 2020

Study information

• Verified date: June 2020
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 23, 2020
• Est. primary completion date: June 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Frailty

Locations

Country	Name	City	State
Belgium	Jessa Hospital Campus Virga Jesse	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of (in)dependence via the Katz scale	Evaluation of the level of (in)dependence in activities of daily life via a 4-point scale (1-4)	At baseline
Primary	Nutritional status via the Mini Nutritional Assessment (MNA)	Examination of the nutritional status of the patient via a questionnaire (30 points)	At baseline
Primary	Level of physical activity via the International Physical Activity Questionnaire (IPAQ)	Examination of the level of physical activity of the patient via a questionnaire	At baseline
Primary	Cognitive status via the Mini Mental State Examination (MMSE)	Examination of the cognitive status of the patient via a short screening (30 points)	At baseline
Primary	Psychological status via the Geriatric Depression Scale (GDS-15)	Examination of the presence/absence of a depressive mood via a questionnaire (15 questions/15 points)	At baseline
Primary	Concern about falling via the Falls Efficacy Scale (FES-I)	Examination of the level of concern about falling during social and physical activities via a questionnaire (16 questions/ 64 points)	At baseline
Primary	Weight loss via the evaluation of body weight	Evaluation of involuntary loss of body weight in the previous months	At baseline
Primary	Gait speed via the 4.6 meter walking test	Examination of the walking speed of the patient	At baseline
Primary	Evaluation of handgrip strength	Evaluation of the handgrip strength of the patient via handheld dynamometry	At baseline
Primary	Examination of mobility/balance/muscle strength/risk of falling via the Timed Up and Go Test (TUG)	The Timed Up and Go Test measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. By combining this test with a motor or cognitive dual task, the risk of falling of the patient will be examined.	At baseline
Primary	Comorbidities via the record of medication use	Record of cardiac and other medications	At baseline
Primary	Evaluation of lower limb strength	Evaluation of lower limb strength of the patient via Microfet measurements	At baseline
Primary	Evaluation of functional lower limb strength	Evaluation of functional lower limb strength of the patient via the Timed Chair Stand Test	At baseline
Secondary	Correlations between frailty (via the primary frailty outcome measures) and exercise parameters (via the maximal exercise test (CPET)	Evaluation of correlations between frailty characteristics (from the primary outcome measures) and exercise parameters from a maximal exercise test (CPET) (performed at the start of a cardiac rehabilitation program).	At the start of the cardiac rehabilitation program