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

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).

Study Overview

• Status: Completed
• Conditions: Frailty

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Hospital Campus Virga Jesse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Men and women with an age of at least 65 years at the start of the study who are admitted to Jessa Hospital Hasselt because of suffering from coronary artery diseases (with planned PCI or CABG surgery) or heart failure

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Nutritional status via the Mini Nutritional Assessment (MNA)	Examination of the nutritional status of the patient via a questionnaire (30 points)	At baseline
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
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
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
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
Weight loss via the evaluation of body weight	Evaluation of involuntary loss of body weight in the previous months	At baseline
Gait speed via the 4.6 meter walking test	Examination of the walking speed of the patient	At baseline
Evaluation of handgrip strength	Evaluation of the handgrip strength of the patient via handheld dynamometry	At baseline
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
Comorbidities via the record of medication use	Record of cardiac and other medications	At baseline
Evaluation of lower limb strength	Evaluation of lower limb strength of the patient via Microfet measurements	At baseline
Evaluation of functional lower limb strength	Evaluation of functional lower limb strength of the patient via the Timed Chair Stand Test	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): June 23, 2020
• Study Completion (Actual): June 23, 2020

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: older adults; cardiovascular diseases; maximal exercise test
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Frailty
• Other Study ID Numbers: FrCR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No