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Набор скоро начнётся NCT07163741

Validity and Reliability of the 6-Minute Pegboard and Ring Test in Patients With Coronary Artery Disease

Наблюдательное Coronary Artery Disease (CAD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Coronary Artery Disease (CAD). Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Coronary artery disease, a cardiovascular disease, causes significant mortality and morbidity. Due to the impairment of arterial blood flow in coronary artery disease, the heart muscle cannot receive an adequate blood supply during exercise, resulting in symptoms such as chest pain, shortness of breath, and fatigue, which can lead to a decrease in exercise capacity. The 6-Minute Pegboard and Ring Test is a simple, rapid, and inexpensive assessment tool used to evaluate upper extremity exercise capacity. The purpose of this study was to assess the validity and reliability of the 6-Minute Pegboard and Ring Test in patients with coronary artery disease.

Подробное описание

Coronary artery disease, a cardiovascular disease, causes significant mortality and morbidity. Due to the impairment of arterial blood flow in coronary artery disease, the heart muscle cannot receive an adequate blood supply during exercise, resulting in symptoms such as chest pain, shortness of breath, and fatigue, which can lead to a decrease in exercise capacity. The 6-Minute Pegboard and Ring Test is a simple, rapid, and inexpensive assessment tool used to evaluate upper extremity exercise capacity. The purpose of this study was to assess the validity and reliability of the 6-Minute Pegboard and Ring Test in patients with coronary artery disease.

Within the scope of the study, at least 32 patients diagnosed with coronary artery disease (CAD) will undergo the "6-Minute Pegboard and Ring Test" (6-PBRT), which assesses upper extremity functional exercise capacity, and the upper extremity cardiopulmonary exercise test, which assesses maximal exercise capacity, on two separate days, 48 hours apart. The 6-Minute Pegboard and Ring Test will be repeated twice, 1 hour apart, by the same evaluator. Before and after the test, heart rate (HR), oxygen saturation, respiratory frequency, arm fatigue, general fatigue, and dyspnea parameters will be assessed. In the 6-PBRT, heart rate and oxygen saturation will be measured with a pulse oximeter (Soulfix Fingertip Oximeter Pulse Oxygen Meter, ABD); fatigue and dyspnea will be assessed with the Modified Borg Scale (MBS); and respiratory frequency will be assessed by counting the number of breaths taken per minute. Patients' respiratory muscle strength will be assessed using a portable oral pressure monitor (Micro Medical MicroRM, UK); respiratory function tests will be performed using a spirometer (Cosmed, Class II/Internally Powered Equipment, Italy); and peripheral muscle strength will be assessed using a portable handheld dynamometer (JTECH Power Track Commander, Baltimore, USA). Patients' quality of life will be assessed using the "Heart Quality of Life Scale in Coronary Artery Disease Patients." All assessments and tests will be explained in detail to the patient beforehand.

Первичные конечные точки

  • Upper Limb Functional Exercise Capacity [Срок оценки: Through study completion, an average of 1 year]
  • Maximal Exercise Capacity [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (6)
  • Respiratory Muscle Strength Assessment [Срок оценки: Through study completion, an average of 1 year]
  • Respiratory Function Assessment [Срок оценки: Through study completion, an average of 1 year]
  • Peripheral Muscle Strength Assessment [Срок оценки: Through study completion, an average of 1 year]
  • Assessment of Shortness of Breath and Fatigue [Срок оценки: Through study completion, an average of 1 year]
  • Assessment of Chronotropic Response [Срок оценки: Through study completion, an average of 1 year]
  • Heart Quality of Life (HeartQoL) Scale [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Individuals diagnosed with coronary artery disease by conventional angiography or computed tomography coronary angiography,
  • Clinically stable,
  • Ages between 18 and 85,
  • Volunteering to participate in the study will be included in the study.

Критерии исключения

  • Individuals diagnosed with heart failure,
  • Those diagnosed with moderate-to-severe valvular disease,
  • Those with a history of orthopedic, neurological, or pulmonary disease that could affect exercise testing and exercise capacity,
  • Those with contraindications to exercise testing according to the American College of Sports Medicine (ACSM) criteria,
  • Those with a history of coronary artery bypass surgery will not be included in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Gazi University Faculty of Health Sciences Department of Cardiopulmonary Physiotherapy and — Ankara

Публикации

  • Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available. PMID 15994402
  • Evans JA, Whitelaw WA. The assessment of maximal respiratory mouth pressures in adults. Respir Care. 2009 Oct;54(10):1348-59. PMID 19796415
  • Nashef SA, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR, Lockowandt U. EuroSCORE II. Eur J Cardiothorac Surg. 2012 Apr;41(4):734-44; discussion 744-5. doi: 10.1093/ejcts/ezs043. Epub 2012 Feb 29. PMID 22378855

Идентификаторы

NCT: NCT07163741 · 2025-1418

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗