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Набор по приглашению NCT07577960

Effect of Pulmonary Rehabilitation on Respiratory Parameters in Upper Extremity Burns

Без фазы С лечением Burn Injury Pulmonary Rehabilitation

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
В протоколе указаны: Pulmonary Rehabilitation Program, Conventional Exercise Program.
Кому может быть актуально
Состояния в реестре: Burn Injury, Pulmonary Rehabilitation. Базовые параметры: 18 лет — 65 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 →
Официальное название

The Effect of Pulmonary Rehabilitation on Respiratory Parameters in Individuals With Upper Extremity Burns

Обзор

This study will evaluate the effects of a pulmonary rehabilitation program on breathing function, respiratory muscle activity, respiratory muscle thickness, and functional capacity in adults with upper extremity burns. Participants will be randomly assigned to either a pulmonary rehabilitation group or a control group. The pulmonary rehabilitation group will receive respiratory muscle training together with upper extremity aerobic exercises, while the control group will receive a conventional exercise program. Assessments will be performed before the intervention, at week 3, and after the 6-week intervention period. The results may help improve rehabilitation approaches for people with upper extremity burns.

Подробное описание

Burn injuries may lead to physical limitations, functional loss, and respiratory problems. In individuals with upper extremity burns, pain, scar tissue, and reduced mobility of the shoulder girdle and chest wall may affect breathing mechanics and respiratory muscle performance. These changes may reduce ventilatory capacity and functional capacity during daily activities.

This randomized controlled clinical study will investigate the effects of a pulmonary rehabilitation program in adults with upper extremity burns. The study will be conducted at the Burn Center of Kartal Dr. Lütfi Kırdar City Hospital. Adults aged 18 to 65 years who had an upper extremity burn injury 3 to 12 months before enrollment and who meet the eligibility criteria will be included.

A total of 64 participants will be randomly assigned to two groups: a pulmonary rehabilitation group and a control group. The pulmonary rehabilitation group will receive respiratory muscle training combined with upper extremity aerobic exercises. The control group will receive a conventional exercise program. The intervention period will last 6 weeks.

Participants will be assessed at three time points: before the intervention, at week 3, and after the 6-week intervention. Respiratory function will be assessed using spirometry, including forced vital capacity, forced expiratory volume in one second, and maximum voluntary ventilation. Respiratory muscle activity will be evaluated using surface electromyography. Respiratory muscle thickness and diaphragm excursion will be assessed using ultrasonography. Functional capacity will be measured with the 6-minute walk test.

The study aims to determine whether pulmonary rehabilitation can improve respiratory function, respiratory muscle activity, respiratory muscle morphology, and functional capacity in individuals with upper extremity burns.

Вмешательства

  • Другое Pulmonary Rehabilitation Program
    Participants in the experimental group will receive a 6-week pulmonary rehabilitation program in addition to the conventional exercise program. The pulmonary rehabilitation program will include respiratory muscle training and upper extremity aerobic exercises. Respiratory muscle training will be performed to improve inspiratory and expiratory muscle performance. Upper extremity aerobic exercises will be planned according to the participant's clinical status and tolerance, with the aim of improvi
  • Другое Conventional Exercise Program
    Participants in both groups will receive a 6-week conventional exercise program as standard rehabilitation. The program will include routine rehabilitation exercises commonly used for individuals with upper extremity burns. Exercises will focus on maintaining and improving upper extremity range of motion, flexibility, scar-related mobility, posture, and functional use of the affected limb. The program may include active and active-assisted range of motion exercises, stretching exercises, mobilit

Первичные конечные точки

  • Change in Forced Vital Capacity [Срок оценки: Baseline, week 3, and week 6]
  • Change in Forced Expiratory Volume in One Second [Срок оценки: Baseline, week 3, and week 6]
  • Change in Maximum Voluntary Ventilation [Срок оценки: Baseline, week 3, and week 6]
  • Change in Diaphragm Thickness During Inspiration [Срок оценки: Baseline, week 3, and week 6]
  • Change in Diaphragm Thickness During Expiration [Срок оценки: Baseline, week 3, and week 6]
  • Change in Diaphragm Excursion [Срок оценки: Baseline, week 3, and week 6]
  • Change in 6-Minute Walk Distance [Срок оценки: Baseline, week 3, and week 6]

Критерии участия

Критерии включения

  • Adults aged 18 to 65 years
  • History of upper extremity burn injury 3 to 12 months before enrollment
  • Clinically stable condition, including oxygen saturation greater than 92% and cardiac stability
  • Ability to communicate and follow instructions, with no hearing, cognitive, or motor communication impairment
  • Voluntary agreement to participate in the study and signing the informed consent form

Критерии исключения

  • Burns involving the lower extremity, trunk, or head and neck regions
  • History of chronic pulmonary, cardiac, neurological, or musculoskeletal disease
  • Dependence on mechanical ventilation or respiratory support
  • Severe psychiatric disorder or cognitive impairment
  • Pregnancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Kartal Dr. Lütfi Kırdar City Hospital Burn Unit — Istanbul

Идентификаторы

NCT: NCT07577960 · KartalH

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗