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

NCT ID: NCT06783023

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-05
• Study Completion Date: 2025-03-31

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.

Conditions

Cardiac Implantable Electrical Devices; Upper Extremity Function

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Cardiac Implantable Electronic Devices

individuals with cardiac implantable electronic devices

validity and reliability study

Intervention Type: OTHER

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.

Interventions

validity 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: collaborator

Erol Olcok Corum Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gamze Nur AHISKALI

Physiotherapist Gamze Nur AHISKALI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hitit University Corum Erol Olçok Training and Research Hospital

Çorum, Center, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Gamze N Ahıskalı, Master's degree

Role: CONTACT

gmzahiskali@gmail.com

+905514128687

Facility Contacts

Gamze N Ahıskalı, master

Role: primary

gmzahiskal@gmail.com

+905514128687

Other Identifiers

2024-08/2

Identifier Type: -

Identifier Source: org_study_id