PacemakerNCT06775691
Comparison of Upper Extremity Function, Physical Activity Levels and Peripheral Muscle Strength, Fear of Movement, Balance, Activities of Daily Living and Quality of Life in Patients With Pacemakers According to Pacemaker Type
An observational study of Pacemaker and Implantable Cardioverter Defibrillator, run by Erol Olcok Corum Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
While research and clinical practice have demonstrated the objective benefits of pacemaker use on mortality, morbidity, and quality of life, some patients do not experience the expected level of improvement following device implantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2024to 1 Jan 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who regularly visit for pacemaker check-ups will be invited to participate in the study.
Who may be able to join
- At least 3 months have passed since pacemaker implantation and there are no complications in the last pacemaker control,
- Being in NYHA class I-II-III,
- Patients with no coordination problems,
- Volunteering to participate in the research
Who cannot join
- Patients with a history of shoulder pathologies prior to pacemaker implantation that may restrict movement of the upper limb (conditions such as severe pain around the shoulder, edema or shoulder dislocation that may restrict upper limb movement),
- Patients with a history of shoulder surgery (limitation in range of motion),
- Patients who have had a cerebrovascular event resulting in mastectomy or arm involvement on the affected side,
- Patients with decompensated heart failure,
- Patients with a history of ICD inappropriate shock,
- Those with acute myocardial infarction,
- Patients with malignancy on active treatment, patients with collagen tissue disease receiving systemic steroids,
- Chronic kidney disease patients on dialysis with unstable volume load
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hitit University Corum Erol Olçok Training and Research Hospital
Çorum, Center, 19000
About this study
While research and clinical practice have demonstrated the objective benefits of pacemaker use on mortality, morbidity, and quality of life, some patients do not experience the expected level of improvement following device implantation. The purpose of this research was to determine the effects of device implantation on daily living activities, upper extremity functions, peripheral muscle strength, balance problems, fear of movement and quality of life.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Pacemaker - PM | |
| Group 2 | Implantable Cardioverter Defibrillator - ICD | |
| Group 3 | Cardiac Resynchronization Therapy - CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of upper extremity functional capacity
6 Minute Peg Board ve Ring Testi - 6PBRT
Measured: 1 years
Evaluation of peripheral muscle strength
Jamar Hydraulic Hand Dynamometer (Baseline Hydraulic Hand Dynamometer, Model: 12-0240, Fabrication Enterprises INC. White Plains, NY 10602 U.S.A.)
Measured: 1 years
Evaluation of balance
Time Up and Go Test - TUG
Measured: 1 years
Evaluation of fear of movement
Tampa Scale of Kinesiophobia for Heart- TSK- HEART / The person receives a total score between 17 and 68. A high score on the scale indicates a high level of kinesiophobia.
Measured: 1 years
Evaluation of physical activity levels
International Pyhsical Activity Questionnaire Short Form, IPAQ / It is calculated using the metabolic equivalent method (MET). There are three different categories. The first category is inactive (<600 MET-minute/week), the second category is minimally active (600-300 MET-minute/week) and the last category is always active (<3000 MET-minute/week).
Measured: 1 years
Evaluation of activities of daily living
Performance Measure for Activities of Daily Living-8 for Patient with Mild Symptomatic Heart Failure- PMADL-8 / The total score ranges from 8-32, with a high score indicating a level of limitation in activities of daily living.
Measured: 1 years
Evaluation of quality of life
Short Form- 36 -SF-36 / Each sub-parameter is scored between 0 and 100. A high score indicates that the individual has a high quality of life.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start5 Apr 2024
- Primary completion12 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Erol Olcok Corum Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Gamze Nur AHISKALI, Erol Olcok Corum Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775691
- Sponsor's protocol ID
- 2024-08/1
- Status last verified
- Jan 2025
- First submitted
- 10 Sep 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Upper Extremity Function, Physical Activity Levels and Peripheral Muscle Strength, Fear of Movement, Balance, Activities of Daily Living and Quality of Life in Patients With Pacemakers According to Pacemaker Type
- ClinicalTrials.gov ID
- NCT06775691
- Acronym / sponsor ID
- 2024-08/1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Erol Olcok Corum Training and Research HospitalUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 15 Jan 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.
While research and clinical practice have demonstrated the objective benefits of pacemaker use on mortality, morbidity, and quality of life, some patients do not experience the expected level of improvement following device implantation. The purpose of this research was to determine the effects of device implantation on daily living activities, upper extremity functions, peripheral muscle strength, balance problems, fear of movement and quality of life.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Pacemaker - PM |
| Group 2 | – | –Implantable Cardioverter Defibrillator - ICD |
| Group 3 | – | –Cardiac Resynchronization Therapy - CRT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who regularly visit for pacemaker check-ups will be invited to participate in the study.
Key inclusion criteria (4 listed)
- At least 3 months have passed since pacemaker implantation and there are no complications in the last pacemaker control,
- Being in NYHA class I-II-III,
- Patients with no coordination problems,
- Volunteering to participate in the research
Key exclusion criteria (8 listed)
- Patients with a history of shoulder pathologies prior to pacemaker implantation that may restrict movement of the upper limb (conditions such as severe pain around the shoulder, edema or shoulder dislocation that may restrict upper limb movement),
- Patients with a history of shoulder surgery (limitation in range of motion),
- Patients who have had a cerebrovascular event resulting in mastectomy or arm involvement on the affected side,
- Patients with decompensated heart failure,
- Patients with a history of ICD inappropriate shock,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of upper extremity functional capacity
Time frame: 1 years
6 Minute Peg Board ve Ring Testi - 6PBRT
Evaluation of peripheral muscle strength
Time frame: 1 years
Jamar Hydraulic Hand Dynamometer (Baseline Hydraulic Hand Dynamometer, Model: 12-0240, Fabrication Enterprises INC. White Plains, NY 10602 U.S.A.)
Evaluation of balance
Time frame: 1 years
Time Up and Go Test - TUG
Evaluation of fear of movement
Time frame: 1 years
Tampa Scale of Kinesiophobia for Heart- TSK- HEART / The person receives a total score between 17 and 68. A high score on the scale indicates a high level of kinesiophobia.
Evaluation of physical activity levels
Time frame: 1 years
International Pyhsical Activity Questionnaire Short Form, IPAQ / It is calculated using the metabolic equivalent method (MET). There are three different categories. The first category is inactive (<600 MET-minute/week), the second category is minimally active (600-300 MET-minute/week) and the last category is always active (<3000 MET-minute/week).
Evaluation of activities of daily living
Time frame: 1 years
Performance Measure for Activities of Daily Living-8 for Patient with Mild Symptomatic Heart Failure- PMADL-8 / The total score ranges from 8-32, with a high score indicating a level of limitation in activities of daily living.
Evaluation of quality of life
Time frame: 1 years
Short Form- 36 -SF-36 / Each sub-parameter is scored between 0 and 100. A high score indicates that the individual has a high quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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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. This study is not recruiting at the moment.
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 Pacemaker and Implantable Cardioverter Defibrillator, run by Erol Olcok Corum Training and Research Hospital 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 8 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of upper extremity functional capacity (time frame: 1 years). The study lists 7 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 8 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.