Clinical trial NCT04675437: Impact of Exercise Training on Frailty in CVD Patients.
Official title: Impact of Aerobic Exercise Training on Markers of Frailty in Heart Failure and CABG Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Cardiovascular Diseases
Keywords: frailty
older adults
cardiovascular diseases
cardiac rehabilitation
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2020-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this research project is to examine the impact of aerobic exercise on markers of frailty in patients (of 65 years or older) suffering from heart failure (HF) or after coronary artery bypass grafting (CABG) or mini aortic valve replacement procedures (mini-AVR).

Detailed description: 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. Based on previous research, there are indications that frailty is highly prevalent in HF, CABG and mini-AVR patients. As a consequence, these patients (both men and women of 65 years or older) will be included in this research project. The 12-week aerobic exercise program (3 sessions per week) will consist of ergometer, treadmill and arm-ergometer exercises. The intensity will be based on the maximal cardiopulmonary exercise test (CPET) of the patient and will correspond with a heart rate between the first and second ventilatory threshold (with a gradual progression over time).

Secondary, correlations will be examined between markers of the CPET and frailty markers.

Eligibility criteria: Inclusion Criteria:

* Men and women of at least 65 years of age at the start of the study
* To be admitted to Jessa Hospital Hasselt for cardiac rehabilitation after CABG or mini-AVR surgery or because of HF
* Diagnosed as being frail based on the Phenotype of Fried.

Exclusion Criteria:

* A persistently unstable clinical condition (e.g. angina, advanced conduction disturbances, threatening ventricular arrhythmias or acute HF)

Primary outcomes:
measure: Change in body weight
timeFrame: At baseline (as part of the identification of frailty)
measure: Gait speed
timeFrame: At baseline (as part of the identification of frailty)
measure: Change in gait speed at 12 weeks
timeFrame: 12 weeks
measure: Level of physical activity based on the Katz-scale
timeFrame: At baseline (as part of the identification of frailty)
measure: Change in level of physical activity at 12 weeks (0-6) (Higher score = better level of physical activity)
timeFrame: 12 weeks
measure: Exhaustion based on 2 questions of the Center of Epidemiologic Studies Depression Scale (CES-D)
timeFrame: At baseline (as part of the identification of frailty)
measure: Change in level of exhaustion at 12 weeks based on 2 questions of the Center of Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 12 weeks
measure: Handgrip strength
timeFrame: At baseline (as part of the identification of frailty)
measure: Change in handgrip strength at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Nutritional status based on the Mini Nutritional Assessement (MNA)
timeFrame: At baseline (as part of the identification of frailty)
measure: Change in nutritional status at 12 weeks based on the Mini Nutritional Assessement (MNA)
timeFrame: 12 weeks
measure: Cognitive status based on the Mini Mental State Examination (MMSE)
timeFrame: At baseline (as part of the identification of frailty)
measure: Change in cognitive status at 12 weeks based on the Mini Mental State Examination (MMSE)
timeFrame: 12 weeks
measure: Physical status/Comorbidities based on the intake of medications
timeFrame: At baseline (as part of the identification of frailty)
measure: Change in physical status/Comorbidities at 12 weeks based on the intake of medications
timeFrame: 12 weeks
measure: Psychological status based on the Geriatric Depression Scale (GDS-15)
timeFrame: At baseline (as part of the identification of frailty)
measure: Change in psychological status at 12 weeks based on the Geriatric Depression Scale (GDS-15)
timeFrame: 12 weeks
measure: Endurance/Balance/Coordination
timeFrame: At baseline (as part of the identification of frailty)
measure: Change in endurance/Balance/Coordination at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Hasselt University
name: Dominique Hansen, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: