Impact of Exercise Training on Frailty in CVD Patients.

December 14, 2020 updated by: Dominique Hansen, Hasselt University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Recruiting
        • Jessa Hospital
        • Contact:
        • Principal Investigator:
          • Nastasia Marinus, Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At baseline (as part of the identification of frailty)
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.
At baseline (as part of the identification of frailty)
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.
12 weeks
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)
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)
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)
12 weeks
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)
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)
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)
12 weeks
Handgrip strength
Time Frame: At baseline (as part of the identification of frailty)
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
Time Frame: 12 weeks
To examine the change in handgrip strength measured with the Jamar handheld dynamometer.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nutritional status based on the Mini Nutritional Assessement (MNA)
Time Frame: 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)
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
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)
Time Frame: 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)
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
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
Time Frame: At 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)
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
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)
Time Frame: 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)
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
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
Time Frame: At 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
At baseline (as part of the identification of frailty)
Change in endurance/Balance/Coordination at 12 weeks
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jessa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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