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

NCT04206904 | Completed

• 1 other identifier: FrCR
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

older adults; cardiovascular diseases; maximal exercise test

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (1)

• 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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Jessa Hospital Campus Virga Jesse

Hasselt, Limburg, 3500, Belgium

Location

MeSH Terms

Conditions

Frailty; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invesigator

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 20, 2019
• Study Start: November 25, 2019
• Primary Completion: June 23, 2020
• Study Completion: June 23, 2020
• Last Updated: June 24, 2020

Record last verified: 2020-06

Locations

BE (1)