Exercise Capacity Muscle Oxygenation and Arterial Stiffness in Children With Pulmonary Arterial Hypertension

Обзор

The primary aim is to evaluate pulmonary function, respiratory muscle strength, upper and lower extremity exercise capacity, muscle oxygenation, dyspnea, peripheral muscle strength, arterial stiffness, physical activity level and balance in children with pulmonary arterial hypertension and compare with age- and sex-matched healthy controls. The second aim is to investigate the relationship between upper extremity exercise capacity, arterial stiffness, respiratory and peripheral muscle strength

Подробное описание

Pulmonary arterial hypertension (PAH) is defined as higher than 25 mmHg in mean pulmonary arterial pressure at rest. Pulmonary arterial hypertension is chronic and progressive disease.

Symptoms such as dyspnea, fatigue, exercise intolerance, cyanosis and syncope are shown in children with PAH. Most common symptom is dyspnea during exertion. Dyspnea at rest could occur while the severity of disease is progressed. All these symptoms have been associated with decreased cardiac output and mismatch oxygen transport.

This study is planned as a cross-sectional study. At least 13 children with PAH and at least 13 age- and sex- matched healthy controls will be included in this study. Individuals' pulmonary function (spirometer), respiratory muscle strength (mouth pressure device), upper extremity exercise capacity (the six minute Peg Board Ring Test), lower extremity exercise capacity (six minute walk test), muscle oxygenation ('Moxy' monitor device), dyspnea (modified Borg Scale), peripheral muscle strength (hand-held dynamometer), arterial stiffness (arteriograph device), physical activity level (multi-sensor activity monitor) and static balance (balance system with computed) will evaluated in children with PAH and healthy controls. All assessments will be completed in two days.

Первичные конечные точки

• Upper extremity exercise capacity [Срок оценки: First day]
• Muscle oxygenation [Срок оценки: First day]

Вторичные конечные точки (12)

• Respiratory muscle strength [Срок оценки: First day]
• Peripheral muscle strength [Срок оценки: Second day]
• Dyspnea [Срок оценки: Second day]
• Lower extremity exercise capacity [Срок оценки: Second day]
• Physical activity (Total energy expenditure) [Срок оценки: Second day]
• Physical activity (Active energy expenditure) [Срок оценки: Second day]
• Physical activity (Physical activity duration) [Срок оценки: Second day]
• Physical activity (Average metabolic equivalent) [Срок оценки: Second day]
• Physical activity (Number of steps) [Срок оценки: Second day]
• Physical activity (Lying down duration) [Срок оценки: Second day]
• Physical activity (Sleep duration) [Срок оценки: Second day]
• Pulmonary function (Forced expiratory volume in the first second (FEV1)) [Срок оценки: First day]

Критерии участия

Критерии включения

Patients:

• Between the ages of 6-18
• Diagnosed with pulmonary arterial hypertension
• Stability of clinical condition and receiving standard medical treatment

Healthy controls:

• Between the ages of 6-18
• Willing to participate in the study

Критерии исключения

Patients:

• Having any acute infection, orthopedic, neurological, cooperation, vision or hearing problems that may prevent during the measurements
• Participated in a planned exercise program in a last three months

Healthy controls:

• Having any acute or chronic illness
• Active or ex-smoker

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, — Ankara

Публикации

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Идентификаторы

NCT: NCT06454838 · Gazi University 2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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