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

NCT ID: NCT07253909

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2027-05-30

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

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

Not applicable- observational study

Intervention Type: OTHER

Not applicable- observational study

Interventions

Not applicable- observational study

Not applicable- observational study

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Aynur Demirel

PT, PhD, Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Samanpazarı, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

FTREK25/74

Identifier Type: -

Identifier Source: org_study_id