FrailtyNCT04675437
Impact of Exercise Training on Frailty in CVD Patients.
A study testing Aerobic exercise in people with Frailty and Cardiovascular Diseases, run by Hasselt University at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Cardiovascular Diseases
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Oct 2020to 20 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- A persistently unstable clinical condition (e.g. angina, advanced conduction disturbances, threatening ventricular arrhythmias or acute HF)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Hospital
Hasselt, Limburg, 3500
Kim Bonné, Msc, 003211337701, kim.bonne@jessazh.be
Nastasia Marinus, Msc
About this study
Official title: 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).
Read the 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.
- Conditions
- Frailty, Cardiovascular Diseases
- Being tested
- Aerobic exercise
- Keywords
- frailty, older adults, cardiovascular diseases, cardiac rehabilitation
- Medical subject headings
- Frailty, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
12-weeks aerobic exercise program
| Study group | Role | What they receive |
|---|---|---|
| Frail patients (CABG, HF or mini-AVR) | Experimental | 12-weeks cardiac exercise program (3 sessions per week) consisting of aerobic exercises (ergometer, treadmill and arm ergometer). Receives: Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
To examine whether there was a change in body weight (not due to a diet) in the last year
Measured: At baseline (as part of the identification of frailty)
Gait speed
To examine the gait speed based on the 4.6 metres walking test.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 weeks
Handgrip strength
To examine the handgrip strength measured with the Jamar handheld dynamometer.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (10)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 weeks
Endurance/Balance/Coordination
To examine the endurance, balance and coordination of the patients based on the Timed up and Go Test
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start20 Oct 2020
- Primary completion20 Oct 2021 (estimated)
- Study completion20 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Dominique Hansen, Prof. dr., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675437
- Sponsor's protocol ID
- FR-AT-CVD
- Status last verified
- Dec 2020
- First submitted
- 7 Dec 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aerobic Exercise Training on Markers of Frailty in Heart Failure and CABG Patients
- ClinicalTrials.gov ID
- NCT04675437
- Acronym / sponsor ID
- FR-AT-CVD
- Conditions
- Frailty, Cardiovascular Diseases
- Keywords
- frailty, older adults, cardiovascular diseases, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 20 Oct 2021 (estimated)
- Study completion
- 20 Oct 2021 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail patients (CABG, HF or mini-AVR) | Experimental | Other: Aerobic exercise12-weeks cardiac exercise program (3 sessions per week) consisting of aerobic exercises (ergometer, treadmill and arm ergometer). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- A persistently unstable clinical condition (e.g. angina, advanced conduction disturbances, threatening ventricular arrhythmias or acute HF)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise12-weeks aerobic exercise program | Other | Frail patients (CABG, HF or mini-AVR) |
Primary outcome
Change in body weight
Time frame: At 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 speed
Time frame: At 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 weeks
Time frame: 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
Time frame: At 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)
Time frame: 12 weeks
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)
Time frame: 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)
Time frame: 12 weeks
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
Time frame: At 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 weeks
Time frame: 12 weeks
To examine the change in handgrip strength measured with the Jamar handheld dynamometer.
10 secondary outcomes
Nutritional status based on the Mini Nutritional Assessement (MNA)
Time frame: At baseline (as part of the identification of frailty)
Change in nutritional status at 12 weeks based on the Mini Nutritional Assessement (MNA)
Time frame: 12 weeks
Cognitive status based on the Mini Mental State Examination (MMSE)
Time frame: At baseline (as part of the identification of frailty)
Change in cognitive status at 12 weeks based on the Mini Mental State Examination (MMSE)
Time frame: 12 weeks
Physical status/Comorbidities based on the intake of medications
Time frame: At baseline (as part of the identification of frailty)
Change in physical status/Comorbidities at 12 weeks based on the intake of medications
Time frame: 12 weeks
Psychological status based on the Geriatric Depression Scale (GDS-15)
Time frame: At baseline (as part of the identification of frailty)
Change in psychological status at 12 weeks based on the Geriatric Depression Scale (GDS-15)
Time frame: 12 weeks
Endurance/Balance/Coordination
Time frame: At baseline (as part of the identification of frailty)
Change in endurance/Balance/Coordination at 12 weeks
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Hansen, Prof. dr. principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Frailty and Cardiovascular Diseases, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nastasia Marinus, Msc (003211269203, nastasia.marinus@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: At baseline (as part of the identification of frailty)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.