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

Completed

• Conditions: Frailty

• Registration Number: NCT04206904
• Lead Sponsor: Hasselt University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-25
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-20
• Status Verified: 2020-06
• Primary Completion: 2020-06-23
• Study Completion: 2020-06-23
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive status via the Mini Mental State Examination (MMSE)	At baseline	Examination of the cognitive status of the patient via a short screening (30 points)
Psychological status via the Geriatric Depression Scale (GDS-15)	At baseline	Examination of the presence/absence of a depressive mood via a questionnaire (15 questions/15 points)
Level of (in)dependence via the Katz scale	At baseline	Evaluation of the level of (in)dependence in activities of daily life via a 4-point scale (1-4)
Level of physical activity via the International Physical Activity Questionnaire (IPAQ)	At baseline	Examination of the level of physical activity of the patient via a questionnaire
Examination of mobility/balance/muscle strength/risk of falling via the Timed Up and Go Test (TUG)	At baseline	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.
Nutritional status via the Mini Nutritional Assessment (MNA)	At baseline	Examination of the nutritional status of the patient via a questionnaire (30 points)
Comorbidities via the record of medication use	At baseline	Record of cardiac and other medications
Concern about falling via the Falls Efficacy Scale (FES-I)	At baseline	Examination of the level of concern about falling during social and physical activities via a questionnaire (16 questions/ 64 points)
Weight loss via the evaluation of body weight	At baseline	Evaluation of involuntary loss of body weight in the previous months
Evaluation of handgrip strength	At baseline	Evaluation of the handgrip strength of the patient via handheld dynamometry
Gait speed via the 4.6 meter walking test	At baseline	Examination of the walking speed of the patient
Evaluation of lower limb strength	At baseline	Evaluation of lower limb strength of the patient via Microfet measurements
Evaluation of functional lower limb strength	At baseline	Evaluation of functional lower limb strength of the patient via the Timed Chair Stand Test

Secondary Outcome Measures

Name	Time	Method
Correlations between frailty (via the primary frailty outcome measures) and exercise parameters (via the maximal exercise test (CPET)	At the start of the cardiac rehabilitation program	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).

Trial Locations

Locations (1)

Jessa Hospital Campus Virga Jesse; 🇧🇪 Hasselt, Limburg, Belgium