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

NCT06775691 | Recruiting

• 1 other identifier: 2024-08/1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pacemaker; Implantable Cardioverter Defibrillator; Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

Group 1

Pacemaker - PM

Group 2

Implantable Cardioverter Defibrillator - ICD

Group 3

Cardiac Resynchronization Therapy - CRT

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

You may qualify if:

• 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

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, patients with 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 AHISKALI, Master's degree

CONTACT

+0905514128687; gmzahiskali@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist Gamze Nur AHISKALI

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: January 15, 2025
• Study Start: April 5, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

TU (1)