Impact of Exercise Training on Frailty in CVD Patients.

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04675437
• Other study ID #: FR-AT-CVD
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: October 20, 2021

Study information

• Verified date: December 2020
• Source: Hasselt University
• Contact: Nastasia Marinus, Msc
• Phone: 003211269203
• Email: nastasia.marinus[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Frailty

Intervention

Other:
• Aerobic exercise
12-weeks aerobic exercise program

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Gait speed	To examine the gait speed based on the 4.6 metres walking test.	At baseline (as part of the identification of frailty)
Primary	Change in gait speed at 12 weeks	To examine the change in gait speed based on the 4.6 metres walking test.	12 weeks
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	Handgrip strength	To examine the handgrip strength measured with the Jamar handheld dynamometer.	At baseline (as part of the identification of frailty)
Primary	Change in handgrip strength at 12 weeks	To examine the change in handgrip strength measured with the Jamar handheld dynamometer.	12 weeks
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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