Cardiac Implantable Electrical DevicesNCT06783023
Evaluation of the Validity and Reliability of the '6 Minute Pegboard and Ring Test' Unsupported Arm Function Exercise Test in Patients Using Pacemakers
An observational study of Cardiac Implantable Electrical Devices and Upper Extremity Function, run by Erol Olcok Corum Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Recently, the use of Cardiac Implantable Electronic Devices (CIED) is becoming widespread due to the improvement of patients' symptoms, reduction of sudden cardiac death and improved quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Implantable Electrical Devices, Upper Extremity Function
- What is being tested?
- validity and reliability study
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Mar 2025
- Phase
- Observational
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 with implantable cardiac electrical devices
Who may be able to join
- Patients between the ages of 18-65 who have a pacemaker,
- 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,
- Patients who volunteered to participate in the study.
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, 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
Recently, the use of Cardiac Implantable Electronic Devices (CIED) is becoming widespread due to the improvement of patients' symptoms, reduction of sudden cardiac death and improved quality of life. Although implantation of the device is considered a minor invasive procedure, possible but often underestimated dysfunction of the same side upper extremity may develop after implantation. This increase in the number of device implantations makes shoulder dysfunction after pacemaker implantation a major health problem. In the current research in the literature, arm dysfunction is evaluated by measuring range of motion with a dynamic goniometer, scales scored independently of shoulder pathology and the effect of activities of daily living. This indicates that there is no objective functional assessment method used to evaluate arm function in CIED patients. Therefore, the point of this study is to find out how reliable and valid the 6 Minute Pegboard and Ring Test (6PBRT) is for testing the functional capacity of the upper extremity in people who have had CIED implanted.
- Being tested
- validity and reliability study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
validity and reliability studyOther
In the study, which will include at least 24 individuals with CIED determined by power analysis, unassisted arm exercise capacity and arm function/endurance, maximum arm exercise capacity, double product, heart recovery, comorbidity level, hand grip strength, fear of movement, activities of daily living and quality of life will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Implantable Electronic Devices | individuals with cardiac implantable electronic devices Receives: Other: validity and reliability study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of unsupported arm exercise capacity
6 Minute Pegboard and Ring Test-6PBRT
Measured: 1 year
Evaluation of maximal arm exercise capacity
Arm Ergometer Test / It is a gold standard method used to evaluate upper extremity exercise capacity. At the beginning and end of the test, heart rate, saturation and BORG scale will be evaluated for fatigue and dyspnea. In women, it will start with 20 watts and increase by 6 watts every 1 minute, while in men, it will start with 30 watts and increase by 10 watts every 1 minute. The rotation speed will be maintained at 70 rpm. The test will be terminated if the perceived exertion level is ≥ 18 and/or the rotation speed cannot be maintained above 60 rpm.
Measured: 1 year
Secondary outcomes (4)
Evaluation of hand grip strength
JAMAR Hydraulic Hand Dynamometer
Measured: 1 year
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 year
Evaluation of Quality of Life
MacNew Heart Disease Health-Related Quality of Life Questionnaire / The questions are scored from 1 to 7, with higher scores indicating better quality of life.
Measured: 1 year
Evaluation of Kinesiophobia
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 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 May 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Implantable Electrical DevicesStudies 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
- 27 participants (actual)
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
- NCT06783023
- Sponsor's protocol ID
- 2024-08/2
- 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
Publications
Ahiskali GN, Karavelioglu Y, Yagli NV, Calik E. Validity and Reliability of the 6-Minute Pegboard and Ring Test in Patient With Cardiac Implantable Electrical Devices. Pacing Clin Electrophysiol. 2026 Jul 16. doi: 10.1111/pace.70364. Online ahead of print.
PubMed 42460822