Heart FailureNCT07253909
Upper Extremity Function in Patients With Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices
An observational study of Heart Failure and Implantable Cardioverter Defibrillator (ICD), run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronisation Therapy (CRT)
- What is being tested?
- Not applicable- observational study
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2025to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Samanpazarı, 06100
About this study
Official title: Investigation of Factors Determining Upper Extremity Function in Patients With Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices
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.
Read the 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
- Being tested
- Not applicable- observational study
- Keywords
- function, upper extremity, heart failure, Implantable cardioverter defibrillator (ICD), Cardiac Resynchronisation Therapy (CRT), Reduced ejection fraction heart failure
- Medical subject headings
- Heart Failure, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients with Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices | Patients with Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one day
Secondary outcomes (8)
functional level
The New York Heart Association (NYHA) functional classification levels will be determined. NYHA classifies heart patients clinically from 1 to 4 based on their functional status. It is a strong prognostic indicator and risk factor.
Measured: one day
hand grip strength
Hand grip strength will be assessed using a digital hand dynamometer. During the test, patients will be positioned with their arms alongside their bodies, elbows flexed at 90 degrees, and forearms and wrists in a neutral position. Patients will be asked to grasp the fixed dynamometer with maximum force.
Measured: one day
upper extremity functional status
The functional status of the upper extremity will be assessed using the Quick Disability of the Arm, Shoulder, and Hand Questionnaire. Scoring is performed using a 5-point Likert scale. According to this scale, upper extremity activities are scored as follows: 1 no difficulty, 2 mild difficulty, 3 moderate difficulty, 4 severe difficulty, 5 inability to perform. The total score ranges from 0 to 100. "0" indicates that the functions are not affected at all, while "100" indicates that the functions are maximally affected.
Measured: one day
lower extremity functional capacity
Lower extremity functional capacity will be assessed using the one-minute sit-to-stand test. Patients will sit on a back-supported chair without armrests at the start of the test and cross their arms over their shoulders. Starting from this position, patients will be asked to sit down and stand up as quickly as possible for 1 minute. The number of times they sit down and stand up during this 1 minute will be recorded as the test result.
Measured: one day
lower extremity performance
Lower extremity performance will be assessed using a 4-meter walking test. The patient is instructed to start walking at a normal pace on a flat surface measuring 4 meters and to stop at the end of 4 meters. This time is recorded in seconds using a stopwatch.
Measured: one day
daily living activities
Daily living activities will be assessed using the Katz Activities of Daily Living (ADL) Scale. This scale consists of 6 categories: washing, dressing, toileting, transfer, continence, and feeding. Individuals are assessed as follows: 3 points if they can perform daily living activities independently, 2 points if they require partial assistance, and 1 point if they cannot perform the activity at all. In the activities of daily living index, 0-6 points are considered "dependent," 7-12 points are considered "partially dependent," and 13-18 points are considered "independent."
Measured: one day
QoL
Quality of life will be assessed using the Minnesota Quality of Life Scale. This survey consists of 21 questions and asks respondents to answer based on their general situation over the past 4 weeks; it allows for numerical expression ranging from 0 to 5. The total score for this scale is 105. High values indicate low quality of life.
Measured: one day
comorbidity
Comorbidity will be assessed using the Charlson Comorbidity Index. This index includes 19 different diseases rated from 1 to 6, with each disease represented by a specific score. A high CKI Score indicates the presence of additional health problems in the patient and the severity of these problems.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start30 May 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Demirel, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253909
- Sponsor's protocol ID
- FTREK25/74
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Determining Upper Extremity Function in Patients With Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices
- ClinicalTrials.gov ID
- NCT07253909
- Acronym / sponsor ID
- FTREK25/74
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices | – | Other: Not applicable- observational studyPatients with Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | Patients with Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices |
Primary outcome
upper extremity anaerobic capacity
Time frame: one day
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.
upper extremity aerobic capacity
Time frame: one day
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.
Unsupported Upper-limb Exercise Test (UULEX)
Time frame: one day
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.
Upper Limb Functional Test (ULIFT)
Time frame: one day
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.
Mortality risk and average life expectancy estimate
Time frame: one day
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Implantable Cardioverter Defibrillator (ICD), run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper extremity anaerobic capacity (time frame: one day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.