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Impact of Exercise Training on Frailty in CVD Patients.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04675437
Enrollment
50
Registered
2020-12-19
Start date
2020-10-20
Completion date
2021-10-20
Last updated
2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Frailty

Keywords

frailty, older adults, cardiovascular diseases, cardiac rehabilitation

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.

Interventions

OTHERAerobic exercise

12-weeks aerobic exercise program

Sponsors

Jessa Hospital
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in body weightAt baseline (as part of the identification of frailty)To examine whether there was a change in body weight (not due to a diet) in the last year
Gait speedAt baseline (as part of the identification of frailty)To examine the gait speed based on the 4.6 metres walking test.
Change in gait speed at 12 weeks12 weeksTo examine the change in gait speed based on the 4.6 metres walking test.
Level of physical activity based on the Katz-scaleAt baseline (as part of the identification of frailty)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)
Change in level of physical activity at 12 weeks (0-6) (Higher score = better level of physical activity)12 weeksTo 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)
Exhaustion based on 2 questions of the Center of Epidemiologic Studies Depression Scale (CES-D)At baseline (as part of the identification of frailty)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)
Change in level of exhaustion at 12 weeks based on 2 questions of the Center of Epidemiologic Studies Depression Scale (CES-D)12 weeksTo 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)
Handgrip strengthAt baseline (as part of the identification of frailty)To examine the handgrip strength measured with the Jamar handheld dynamometer.
Change in handgrip strength at 12 weeks12 weeksTo examine the change in handgrip strength measured with the Jamar handheld dynamometer.

Secondary

MeasureTime frameDescription
Nutritional status based on the Mini Nutritional Assessement (MNA)At baseline (as part of the identification of frailty)To examine the nutritional status based on the MNA (score of 0-30 in which a higher score indicates a better nutritional status)
Change in endurance/Balance/Coordination at 12 weeks12 weeksTo examine the change in endurance, balance and coordination of the patients based on the Timed up and Go Test
Change in nutritional status at 12 weeks based on the Mini Nutritional Assessement (MNA)12 weeksTo 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)
Cognitive status based on the Mini Mental State Examination (MMSE)At baseline (as part of the identification of frailty)To examine the cognitive status based on the MMSE (score of 0-30 in which a higher score indicates a better cognitive status)
Change in cognitive status at 12 weeks based on the Mini Mental State Examination (MMSE)12 weeksTo examine the change in cognitive status based on the MMSE (score of 0-30 in which a higher score indicates a better cognitive status)
Physical status/Comorbidities based on the intake of medicationsAt baseline (as part of the identification of frailty)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)
Change in physical status/Comorbidities at 12 weeks based on the intake of medications12 weeksTo 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)
Psychological status based on the Geriatric Depression Scale (GDS-15)At baseline (as part of the identification of frailty)To examine the psychological status based on the GDS-15 (score of 0-15 in which a higher score indicates a more depressed state)
Change in psychological status at 12 weeks based on the Geriatric Depression Scale (GDS-15)12 weeksTo 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)
Endurance/Balance/CoordinationAt baseline (as part of the identification of frailty)To examine the endurance, balance and coordination of the patients based on the Timed up and Go Test

Countries

Belgium

Contacts

Primary ContactNastasia Marinus, Msc
nastasia.marinus@uhasselt.be003211269203
Backup ContactDominique Hansen, Prof. dr.
dominique.hansen@uhasselt.be003211292126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026