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Impact of Exercise Training on Frailty in CVD Patients.

Primary Purpose

Frailty, Cardiovascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty focused on measuring frailty, older adults, cardiovascular diseases, cardiac rehabilitation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Jessa HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Frail patients (CABG, HF or mini-AVR)

Arm Description

12-weeks cardiac exercise program (3 sessions per week) consisting of aerobic exercises (ergometer, treadmill and arm ergometer).

Outcomes

Primary Outcome Measures

Change in body weight
To examine whether there was a change in body weight (not due to a diet) in the last year
Gait speed
To examine the gait speed based on the 4.6 metres walking test.
Change in gait speed at 12 weeks
To examine the change in gait speed based on the 4.6 metres walking test.
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)
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)
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)
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)
Handgrip strength
To examine the handgrip strength measured with the Jamar handheld dynamometer.
Change in handgrip strength at 12 weeks
To examine the change in handgrip strength measured with the Jamar handheld dynamometer.

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
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)
Endurance/Balance/Coordination
To examine the endurance, balance and coordination of the patients based on the Timed up and Go Test
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

Full Information

First Posted
December 7, 2020
Last Updated
December 14, 2020
Sponsor
Hasselt University
Collaborators
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04675437
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
October 20, 2021 (Anticipated)
Study Completion Date
October 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Cardiovascular Diseases
Keywords
frailty, older adults, cardiovascular diseases, cardiac rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Frail patients (CABG, HF or mini-AVR)
Arm Type
Experimental
Arm Description
12-weeks cardiac exercise program (3 sessions per week) consisting of aerobic exercises (ergometer, treadmill and arm ergometer).
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
12-weeks aerobic exercise program
Primary Outcome Measure Information:
Title
Change in body weight
Description
To examine whether there was a change in body weight (not due to a diet) in the last year
Time Frame
At baseline (as part of the identification of frailty)
Title
Gait speed
Description
To examine the gait speed based on the 4.6 metres walking test.
Time Frame
At baseline (as part of the identification of frailty)
Title
Change in gait speed at 12 weeks
Description
To examine the change in gait speed based on the 4.6 metres walking test.
Time Frame
12 weeks
Title
Level of physical activity based on the Katz-scale
Description
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)
Time Frame
At baseline (as part of the identification of frailty)
Title
Change in level of physical activity at 12 weeks (0-6) (Higher score = better level of physical activity)
Description
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)
Time Frame
12 weeks
Title
Exhaustion based on 2 questions of the Center of Epidemiologic Studies Depression Scale (CES-D)
Description
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)
Time Frame
At baseline (as part of the identification of frailty)
Title
Change in level of exhaustion at 12 weeks based on 2 questions of the Center of Epidemiologic Studies Depression Scale (CES-D)
Description
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)
Time Frame
12 weeks
Title
Handgrip strength
Description
To examine the handgrip strength measured with the Jamar handheld dynamometer.
Time Frame
At baseline (as part of the identification of frailty)
Title
Change in handgrip strength at 12 weeks
Description
To examine the change in handgrip strength measured with the Jamar handheld dynamometer.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Nutritional status based on the Mini Nutritional Assessement (MNA)
Description
To examine the nutritional status based on the MNA (score of 0-30 in which a higher score indicates a better nutritional status)
Time Frame
At baseline (as part of the identification of frailty)
Title
Change in nutritional status at 12 weeks based on the Mini Nutritional Assessement (MNA)
Description
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)
Time Frame
12 weeks
Title
Cognitive status based on the Mini Mental State Examination (MMSE)
Description
To examine the cognitive status based on the MMSE (score of 0-30 in which a higher score indicates a better cognitive status)
Time Frame
At baseline (as part of the identification of frailty)
Title
Change in cognitive status at 12 weeks based on the Mini Mental State Examination (MMSE)
Description
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)
Time Frame
12 weeks
Title
Physical status/Comorbidities based on the intake of medications
Description
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)
Time Frame
At baseline (as part of the identification of frailty)
Title
Change in physical status/Comorbidities at 12 weeks based on the intake of medications
Description
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)
Time Frame
12 weeks
Title
Psychological status based on the Geriatric Depression Scale (GDS-15)
Description
To examine the psychological status based on the GDS-15 (score of 0-15 in which a higher score indicates a more depressed state)
Time Frame
At baseline (as part of the identification of frailty)
Title
Change in psychological status at 12 weeks based on the Geriatric Depression Scale (GDS-15)
Description
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)
Time Frame
12 weeks
Title
Endurance/Balance/Coordination
Description
To examine the endurance, balance and coordination of the patients based on the Timed up and Go Test
Time Frame
At baseline (as part of the identification of frailty)
Title
Change in endurance/Balance/Coordination at 12 weeks
Description
To examine the change in endurance, balance and coordination of the patients based on the Timed up and Go Test
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nastasia Marinus, Msc
Phone
003211269203
Email
nastasia.marinus@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Hansen, Prof. dr.
Phone
003211292126
Email
dominique.hansen@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Hansen, Prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Bonné, Msc
Phone
003211337701
Email
kim.bonne@jessazh.be
First Name & Middle Initial & Last Name & Degree
Nastasia Marinus, Msc

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Exercise Training on Frailty in CVD Patients.

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