Impact of Exercise Training on Frailty in CVD Patients.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Aerobic Exercise Training on Markers of Frailty in Heart Failure and CABG Patients

Conditions
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Frailty, Cardiovascular Diseases

Intervention / Treatment
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* Other: Aerobic exercise


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Frail patients (CABG, HF or mini-AVR)<br>12-weeks cardiac exercise program (3 sessions per week) consisting of aerobic exercises (ergometer, treadmill and arm ergometer). | Other: Aerobic exercise<br>* 12-weeks aerobic exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | To examine whether there was a change in body weight (not due to a diet) in the last year | At baseline (as part of the identification of frailty) | 
| Gait speed | To examine the gait speed based on the 4.6 metres walking test. | At baseline (as part of the identification of frailty) | 
| Change in gait speed at 12 weeks | To examine the change in gait speed based on the 4.6 metres walking test. | 12 weeks | 
| Level of physical activity based on the Katz-scale | To examine the level of physical activity based on the Katz-scale (which measures the level of (in)dependence in activities of daily living) (score of 0-6 in which a higher score indicates a better level of physical activity) | At baseline (as part of the identification of frailty) | 
| Change in level of physical activity at 12 weeks (0-6) (Higher score = better level of physical activity) | To examine the change in level of physical activity based on the Katz-scale (which measures the level of (in)dependence in activities of daily living) (score of 0-6 in which a higher score indicates a better level of physical activity) | 12 weeks | 
| Exhaustion based on 2 questions of the Center of Epidemiologic Studies Depression Scale (CES-D) | To examine whether the patients suffer from exhaustion based on two questions of the CES-D (in which a score of 2 or 3 on both questions indicates that the patient suffers from exhaustion) | At baseline (as part of the identification of frailty) | 
| Change in level of exhaustion at 12 weeks based on 2 questions of the Center of Epidemiologic Studies Depression Scale (CES-D) | To examine whether there is a change in the level of experienced exhaustion based on two questions of the CES-D (in which a score of 2 or 3 on both questions indicates that the patient suffers from exhaustion) | 12 weeks | 
| Handgrip strength | To examine the handgrip strength measured with the Jamar handheld dynamometer. | At baseline (as part of the identification of frailty) | 
| Change in handgrip strength at 12 weeks | To examine the change in handgrip strength measured with the Jamar handheld dynamometer. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status based on the Mini Nutritional Assessement (MNA) | To examine the nutritional status based on the MNA (score of 0-30 in which a higher score indicates a better nutritional status) | At baseline (as part of the identification of frailty) | 
| Change in nutritional status at 12 weeks based on the Mini Nutritional Assessement (MNA) | To examine the change in the nutritional status based on the MNA (score of 0-30 in which a higher score indicates a better nutritional status) | 12 weeks | 
| Cognitive status based on the Mini Mental State Examination (MMSE) | To examine the cognitive status based on the MMSE (score of 0-30 in which a higher score indicates a better cognitive status) | At baseline (as part of the identification of frailty) | 
| Change in cognitive status at 12 weeks based on the Mini Mental State Examination (MMSE) | To examine the change in cognitive status based on the MMSE (score of 0-30 in which a higher score indicates a better cognitive status) | 12 weeks | 
| Physical status/Comorbidities based on the intake of medications | To examine the physical status based on the number of medications (in which a higher level of medication intake / higher number of medications indicates a more worse physical status) | At baseline (as part of the identification of frailty) | 
| Change in physical status/Comorbidities at 12 weeks based on the intake of medications | To examine the change in physical status based on the intake of medications (in which a higher level of medication intake / higher number of medications indicates a more worse physical status) | 12 weeks | 
| Psychological status based on the Geriatric Depression Scale (GDS-15) | To examine the psychological status based on the GDS-15 (score of 0-15 in which a higher score indicates a more depressed state) | At baseline (as part of the identification of frailty) | 
| Change in psychological status at 12 weeks based on the Geriatric Depression Scale (GDS-15) | To examine change in the psychological status based on the GDS-15 (score of 0-15 in which a higher score indicates a more depressed state) | 12 weeks | 
| Endurance/Balance/Coordination | To examine the endurance, balance and coordination of the patients based on the Timed up and Go Test | At baseline (as part of the identification of frailty) | 
| Change in endurance/Balance/Coordination at 12 weeks | To examine the change in endurance, balance and coordination of the patients based on the Timed up and Go Test | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frailty, older adults, cardiovascular diseases, cardiac rehabilitation