Upper Extremity Function in Patients With Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices

Hacettepe University

Status: Invitation-only

Conditions: Heart Failure; Implantable Cardioverter Defibrillator (ICD); Reduced Ejection Fraction Heart Failure; Cardiac Resynchronisation Therapy (CRT)

Treatments: Other: Not applicable- observational study

Study type: Observational

Funder types: Other

Identifiers

NCT07253909

FTREK25/74

Details and patient eligibility

About

The aim of this study is to evaluate in detail the factors that determine upper extremity function, determine its effect on prognosis, hospital admission, hospitalization, and mortality, and examine the results according to the use of different implantable cardiac implantable electronic devices.

Full description

In accordance with the inclusion and exclusion criteria appropriate to the purpose of the study, patients with a diagnosis of reduced ejection fraction heart failure and a cardiac implantable electronic device will be included. The demographic and clinical data of the individuals will be recorded. Their functional levels will be determined according to the New York Heart Association (NYHA) classification. Hand grip strength will be measured using a hand dynamometer, upper extremity anaerobic capacity will be assessed using a medicine ball throw test, upper extremity aerobic capacity will be evaluated using an arm ergometer test, and upper extremity functional exercise capacity will be assessed using the Unsupported Upper-limb Exercise Test (UULEX) and the Upper Limb Functional Test (ULIFT). Lower extremity functional capacity will be determined using the one-minute sit-to-stand test, and lower extremity performance will be determined using the 4-meter walk test. The Seattle Heart Failure Model will be used to estimate mortality risk and average life expectancy. Upper extremity functional status will be assessed using the Quick Disability of the Arm, Shoulder, and Hand Questionnaire, activities of daily living using the Katz Activities of Daily Living Scale, and quality of life using the Minnesota Quality of Life Scale. Comorbidity status will be determined using the Charlson Comorbidity Index.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged ≥18 years,
• Left ventricular ejection fraction ≤40%,
• Implanted cardiac defibrillator (ICD) or cardiac resynchronization therapy (CRT),
• Diagnosed with heart failure,
• No complications found during the last device check,
• Clinically stable for the past month, with any accompanying chronic diseases (such as hypertension, diabetes) under control, and willing to participate in the study.

Exclusion criteria

• Patients with neurological, orthopedic, or psychiatric disorders,
• History of shoulder surgery or shoulder injury,
• Individuals with cognitive or mental disorders that would prevent them from understanding the tests administered in the study, or patients who are unwilling to participate

Trial design

72 participants in 1 patient group

Patients with Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices

Description:

Patients with Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices

Treatment:

Other: Not applicable- observational study