Skip to main content
OpenTrials
Completed

NCT Number: NCT04206904

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Frailty Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jessa Hospital Campus Virga Jesse

Hasselt, Limburg, 3500, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Level of (in)dependence via the Katz scale

    Time frame: At baseline

    Evaluation of the level of (in)dependence in activities of daily life via a 4-point scale (1-4)

  2. Nutritional status via the Mini Nutritional Assessment (MNA)

    Time frame: At baseline

    Examination of the nutritional status of the patient via a questionnaire (30 points)

  3. Level of physical activity via the International Physical Activity Questionnaire (IPAQ)

    Time frame: At baseline

    Examination of the level of physical activity of the patient via a questionnaire

  4. Cognitive status via the Mini Mental State Examination (MMSE)

    Time frame: At baseline

    Examination of the cognitive status of the patient via a short screening (30 points)

  5. Psychological status via the Geriatric Depression Scale (GDS-15)

    Time frame: At baseline

    Examination of the presence/absence of a depressive mood via a questionnaire (15 questions/15 points)

  6. Concern about falling via the Falls Efficacy Scale (FES-I)

    Time frame: At baseline

    Examination of the level of concern about falling during social and physical activities via a questionnaire (16 questions/ 64 points)

  7. Weight loss via the evaluation of body weight

    Time frame: At baseline

    Evaluation of involuntary loss of body weight in the previous months

  8. Gait speed via the 4.6 meter walking test

    Time frame: At baseline

    Examination of the walking speed of the patient

  9. Evaluation of handgrip strength

    Time frame: At baseline

    Evaluation of the handgrip strength of the patient via handheld dynamometry

  10. Examination of mobility/balance/muscle strength/risk of falling via the Timed Up and Go Test (TUG)

    Time frame: 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.

  11. Comorbidities via the record of medication use

    Time frame: At baseline

    Record of cardiac and other medications

  12. Evaluation of lower limb strength

    Time frame: At baseline

    Evaluation of lower limb strength of the patient via Microfet measurements

  13. Evaluation of functional lower limb strength

    Time frame: At baseline

    Evaluation of functional lower limb strength of the patient via the Timed Chair Stand Test

Secondary outcomes

  1. Correlations between frailty (via the primary frailty outcome measures) and exercise parameters (via the maximal exercise test (CPET)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2019
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.