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

NCT07253909 | Enrolling By Invitation

• 1 other identifier: FTREK25/74
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

function; upper extremity; heart failure; Implantable cardioverter defibrillator (ICD); Cardiac Resynchronisation Therapy (CRT); Reduced ejection fraction heart failure

Outcome Measures

Primary Outcomes (5)

• upper extremity anaerobic capacity

  Upper extremity anaerobic capacity will be assessed using the medicine ball throw test. Each patient will be asked to sit with one hand on their chest and throw a 2 kg medicine ball forward with the other hand. After the throw, the spot where the ball first touches the ground will be marked. Scores will be measured in centimeters, then the arithmetic mean will be calculated and recorded.

  one day

• upper extremity aerobic capacity

  Upper extremity aerobic capacity will be assessed using a arm ergometer test. The arm height of the ergometer will be set at shoulder level while seated. After the initial measurements are taken, the arm ergometer will be turned at a load of 0 watts and a speed of 60-75 rpm, and the load will be increased by 10 W every 2 minutes. The peak load reached by the patient will be recorded in watts.

  one day

• Unsupported Upper-limb Exercise Test (UULEX)

  The UULEX contain 8 horizontal levels. Each level is 84 cm wide and 8 cm high, with a distance of 15 cm between level centers. The lowest line corresponds to the participant's knee level. The participant holds a 0.2 kg plastic bar with their arms shoulder-width apart and moves it from the hips toward different levels. Each movement starts at the participant's hip joint and ends at the hip joint. After completing the first level for 2 minutes, the next levels are performed for 1 minute each. The bar is lifted up to 30 times per minute to the beat of a metronome. When participants reach their maximum height, the 0.2 kg bar is replaced with a 0.5 kg bar. They continue lifting to the maximum height with this weight. Then, the weight is increased by 0.5 kg every minute up to 2 kg. The time individuals can perform the test, the maximum weight they reach, and the level achieved will be recorded.

  one day

• Upper Limb Functional Test (ULIFT)

  The ULIFT is a performance test based on the Glittre test, developed to assess upper extremity functional capacity. ULIFT aims to objectively measure upper extremity function, endurance, and capacity for participation in activities of daily living, particularly through lifting movements and range of motion. Participants stand in front of shelves and, using one hand, carry three objects (weighing 1 kg each) from the top shelf (at shoulder height) to the bottom shelf (at waist height) and then from the bottom shelf to the floor; the objects are then returned to the bottom shelf and then to the top shelf. Participants repeat the task five times and are instructed to perform the task as quickly as possible. The test will be administered for both upper extremities. Test duration is recorded in seconds.

  one day

• Mortality risk and average life expectancy estimate

  Mortality risk and average life expectancy estimates will be calculated using the Seattle Heart Failure Model. The Seattle Heart Failure Model will be used via the website. The Seattle Heart Failure Model provides consistent 1, 2, and 3 year survival estimates and average life expectancy estimates based on clinical, pharmacological, laboratory, and device information.

  one day

Secondary Outcomes (8)

• functional level

  one day

• hand grip strength

  one day

• upper extremity functional status

  one day

• lower extremity functional capacity

  one day

• lower extremity performance

  one day

Study Arms (1)

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

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

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study sample consists of patients with reduced ejection fraction heart failure who have a cardiac implantable electronic device, who meet the inclusion criteria, and who volunteer to participate in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Samanpazarı, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD, Assoc. Prof.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

TU (1)