Upper Extremity Function in Patients With Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Not applicable- observational study.
- Who it may be relevant to
- Registry conditions: Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronisation Therapy (CRT), Reduced Ejection Fraction Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigation of Factors Determining Upper Extremity Function in Patients With Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices
Overview
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.
Interventions
- Other Not applicable- observational study
Not applicable- observational study
Primary outcome measures
- upper extremity anaerobic capacity [Time frame: one day]
- upper extremity aerobic capacity [Time frame: one day]
- Unsupported Upper-limb Exercise Test (UULEX) [Time frame: one day]
- Upper Limb Functional Test (ULIFT) [Time frame: one day]
- Mortality risk and average life expectancy estimate [Time frame: one day]
Secondary outcome measures (8)
- functional level [Time frame: one day]
- hand grip strength [Time frame: one day]
- upper extremity functional status [Time frame: one day]
- lower extremity functional capacity [Time frame: one day]
- lower extremity performance [Time frame: one day]
- daily living activities [Time frame: one day]
- QoL [Time frame: one day]
- comorbidity [Time frame: one day]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Turkey (Türkiye) · 1 center
- Hacettepe University Faculty of Physical Therapy and Rehabilitation — Ankara
Identifiers
NCT: NCT07253909 · FTREK25/74