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Impact of Exercise Training on Frailty in CVD Patients.

NCT ID: NCT04675437

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-10-20

Brief Summary

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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

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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

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Frailty Cardiovascular Diseases

Keywords

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frailty older adults cardiovascular diseases cardiac rehabilitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type OTHER

12-weeks aerobic exercise program

Interventions

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Aerobic exercise

12-weeks aerobic exercise program

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Dominique Hansen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dominique Hansen, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

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Jessa Hospital

Hasselt, Limburg, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Nastasia Marinus, Msc

Role: CONTACT

Phone: 003211269203

Email: [email protected]

Dominique Hansen, Prof. dr.

Role: CONTACT

Phone: 003211292126

Email: [email protected]

Facility Contacts

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Kim Bonné, Msc

Role: primary

Other Identifiers

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FR-AT-CVD

Identifier Type: -

Identifier Source: org_study_id