RecruitingNCT06783023

Evaluation of the Validity and Reliability of the '6 Minute Pegboard and Ring Test' Unsupported Arm Function Exercise Test in Patients Using Pacemakers


Sponsor

Erol Olcok Corum Training and Research Hospital

Enrollment

24 participants

Start Date

Apr 5, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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.

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Interventions

OTHERvalidity and reliability study

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.


Locations(1)

Hitit University Corum Erol Olçok Training and Research Hospital

Çorum, Center, Turkey (Türkiye)

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NCT06783023


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