Impact of Exercise Training on Frailty in CVD Patients.

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

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).

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Frailty
• Intervention / Treatment: Other: Aerobic exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Hospital
      • Contact: Kim Bonné, Msc; Phone Number: 003211337701; Email: kim.bonne@jessazh.be
      • Principal Investigator: Nastasia Marinus, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Anticipated): October 20, 2021
• Study Completion (Anticipated): October 20, 2021

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: older adults; frailty; cardiovascular diseases; cardiac rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Frailty
• Other Study ID Numbers: FR-AT-CVD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No