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

NCT06783023 | Recruiting

• 1 other identifier: 2024-08/2
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Evaluation of hand grip strength

  1 year

• Evaluation of Activities of Daily Living

  1 year

• Evaluation of Quality of Life

  1 year

• Evaluation of Kinesiophobia

  1 year

Study Arms (1)

Cardiac Implantable Electronic Devices

individuals with cardiac implantable electronic devices

Other: validity and reliability study

Interventions

validity and reliability study 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.

Cardiac Implantable Electronic Devices

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with implantable cardiac electrical devices

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erol Olcok Corum Training and Research Hospital: lead
• Hacettepe University: collaborator

Study Sites (1)

Hitit University Corum Erol Olçok Training and Research Hospital

Çorum, Center, 19000, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Gamze N Ahıskalı, Master's degree

CONTACT

+905514128687; gmzahiskali@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist Gamze Nur AHISKALI

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: January 20, 2025
• Study Start: April 5, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

TU (1)