Comparison of Upper Extremity Function, Physical Activity Levels and Peripheral Muscle Strength, Fear of Movement, Balance, Activities of Daily Living and Quality of Life in Patients With Pacemakers According to Pacemaker Type

While research and clinical practice have demonstrated the objective benefits of pacemaker use on mortality, morbidity, and quality of life, some patients do not experience the expected level of improvement following device implantation. The purpose of this research was to determine the effects of device implantation on daily living activities, upper extremity functions, peripheral muscle strength, balance problems, fear of movement and quality of life.

Study Overview

• Status: Completed
• Conditions: Cardiac Resynchronization Therapy; Pacemaker; Implantable Cardioverter Defibrillator

• Study Type: Observational
• Enrollment (Actual): 60

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 who regularly visit for pacemaker check-ups will be invited to participate in the study.

Description

Inclusion Criteria:

• 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,
• Volunteering to participate in the research

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, patients with 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

3

Cohorts and Interventions

Group / Cohort
Group 1; Pacemaker - PM
Group 2; Implantable Cardioverter Defibrillator - ICD
Group 3; Cardiac Resynchronization Therapy - CRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of upper extremity functional capacity	6 Minute Peg Board ve Ring Testi - 6PBRT	1 years
Evaluation of peripheral muscle strength	Jamar Hydraulic Hand Dynamometer (Baseline Hydraulic Hand Dynamometer, Model: 12-0240, Fabrication Enterprises INC. White Plains, NY 10602 U.S.A.)	1 years
Evaluation of balance	Time Up and Go Test - TUG	1 years
Evaluation of fear of movement	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 years
Evaluation of physical activity levels	International Pyhsical Activity Questionnaire Short Form, IPAQ / It is calculated using the metabolic equivalent method (MET). There are three different categories. The first category is inactive (<600 MET-minute/week), the second category is minimally active (600-300 MET-minute/week) and the last category is always active (<3000 MET-minute/week).	1 years
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 years
Evaluation of quality of life	Short Form- 36 -SF-36 / Each sub-parameter is scored between 0 and 100. A high score indicates that the individual has a high quality of life.	1 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2024
• Primary Completion (Actual): December 12, 2025
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 15, 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: 2024-08/1

Drug and device information, study documents

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