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OpenTrials
Completed

NCT Number: NCT06775691

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.

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Key information

Conditions

Pacemaker Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillator

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hitit University Corum Erol Olçok Training and Research Hospital

Çorum, Center, 19000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of upper extremity functional capacity

    Time frame: 1 years

    6 Minute Peg Board ve Ring Testi - 6PBRT

  2. Evaluation of peripheral muscle strength

    Time frame: 1 years

    Jamar Hydraulic Hand Dynamometer (Baseline Hydraulic Hand Dynamometer, Model: 12-0240, Fabrication Enterprises INC. White Plains, NY 10602 U.S.A.)

  3. Evaluation of balance

    Time frame: 1 years

    Time Up and Go Test - TUG

  4. Evaluation of fear of movement

    Time frame: 1 years

    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.

  5. Evaluation of physical activity levels

    Time frame: 1 years

    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).

  6. Evaluation of activities of daily living

    Time frame: 1 years

    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.

  7. Evaluation of quality of life

    Time frame: 1 years

    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.

Sponsors and collaborators

Lead sponsor

Erol Olcok Corum Training and Research Hospital

Other

Collaborators

  • Hacettepe University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 15, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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