Clinical trial NCT04206904: Prevalence of Frailty in Patients With a Cardiovascular Disease and Correlations With Markers of Exercise
Official title: Prevalence of Frailty in Patients With a Cardiovascular Disease and Correlations With Markers of Exercise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Keywords: older adults
cardiovascular diseases
maximal exercise test
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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).


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)

Primary outcomes:
measure: Level of (in)dependence via the Katz scale
timeFrame: At baseline
measure: Nutritional status via the Mini Nutritional Assessment (MNA)
timeFrame: At baseline
measure: Level of physical activity via the International Physical Activity Questionnaire (IPAQ)
timeFrame: At baseline
measure: Cognitive status via the Mini Mental State Examination (MMSE)
timeFrame: At baseline
measure: Psychological status via the Geriatric Depression Scale (GDS-15)
timeFrame: At baseline
measure: Concern about falling via the Falls Efficacy Scale (FES-I)
timeFrame: At baseline
measure: Weight loss via the evaluation of body weight
timeFrame: At baseline
measure: Gait speed via the 4.6 meter walking test
timeFrame: At baseline
measure: Evaluation of handgrip strength
timeFrame: At baseline
measure: Examination of mobility/balance/muscle strength/risk of falling via the Timed Up and Go Test (TUG)
timeFrame: At baseline
measure: Comorbidities via the record of medication use
timeFrame: At baseline
measure: Evaluation of lower limb strength
timeFrame: At baseline
measure: Evaluation of functional lower limb strength
timeFrame: At baseline
Secondary outcomes:
measure: Correlations between frailty (via the primary frailty outcome measures) and exercise parameters (via the maximal exercise test (CPET)
timeFrame: At the start of the cardiac rehabilitation program
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital Campus Virga Jesse
state: Limburg
Study officials:
References: