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

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.

Study Overview

• Status: Completed
• Conditions: Upper Extremity Function; Cardiac Implantable Electrical Devices
• Intervention / Treatment: Other: validity and reliability study

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Center
    • Çorum, Center, Turkey (Türkiye), 19000
      • Hitit University Çorum Erol Olçok Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with implantable cardiac electrical devices

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac Implantable Electronic Devices; individuals with cardiac implantable electronic devices	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of unsupported arm exercise capacity	6 Minute Pegboard and Ring Test-6PBRT	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of hand grip strength	JAMAR Hydraulic Hand Dynamometer	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.	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.	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.	1 year

Collaborators and Investigators

• Sponsor: Erol Olcok Corum Training and Research Hospital
• Collaborators: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-08/2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No