Clinical trial NCT06783023: Evaluation of the Validity and Reliability of the '6 Minute Pegboard and Ring Test' Unsupported Arm Function Exercise Test in Patients Using Pacemakers
Official title: Evaluation of the Validity and Reliability of the '6 Minute Pegboard and Ring Test' Unsupported Arm Function Exercise Test in Patients Using Pacemakers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Implantable Electrical Devices
Upper Extremity Function
Lead sponsor: Erol Olcok Corum Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2025-01-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with implantable cardiac electrical devices

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evaluation of unsupported arm exercise capacity
timeFrame: 1 year
measure: Evaluation of maximal arm exercise capacity
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of hand grip strength
timeFrame: 1 year
measure: Evaluation of Activities of Daily Living
timeFrame: 1 year
measure: Evaluation of Quality of Life
timeFrame: 1 year
measure: Evaluation of Kinesiophobia
timeFrame: 1 year
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Hitit University Corum Erol Olçok Training and Research Hospital
state: Center
Study officials:
References: