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Набор скоро начнётся NCT06968273

Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Capacity Assessments in Patients With COPD

Без фазы С лечением Chronic Obstructive Pulmonary Disease (COPD) Muscle Oxygenation Exercise Respiratory Physiotherapy

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: Combined respiratory physiotherapy and cardiovascular-strength training program.
Кому может быть актуально
Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD), Muscle Oxygenation, Exercise, Respiratory Physiotherapy. Базовые параметры: от 18 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
Португалия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Capacity Assessments in Patients With COPD Undergoing a Cardiovascular and Strength Training Program

Обзор

This experimental pre-post intervention study aims to evaluate the effect of a respiratory physiotherapy and combined strength and cardiovascular training program on muscle oxygen saturation and functional capacity in patients with Chronic Obstructive Pulmonary Disease (COPD). Oxygenation of the intercostal, quadriceps, and triceps surae muscles will be assessed using near-infrared spectroscopy (NIRS) during standard physical performance tests (6-Minute Walk Test and 30-Second Chair Stand Test). Additional functional parameters and quality of life will be recorded pre- and post-intervention. The results will contribute to optimizing rehabilitation programs and monitoring intensity and progress through muscle oxygenation data.

Подробное описание

This experimental pre-post study investigates the effects of a combined respiratory physiotherapy and physical training program on muscle oxygen saturation and functional capacity in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). COPD is a highly prevalent condition with a progressive impact on functional capacity, muscle performance, and quality of life. It is associated with systemic repercussions, including skeletal muscle dysfunction and oxygen transport limitations, which impair tolerance to physical activity.

The study will evaluate the acute and cumulative effects of a structured, supervised intervention including respiratory physiotherapy techniques, cardiovascular training, and progressive resistance training. Measurements will be taken before and after the intervention period to assess changes in muscle oxygen saturation-measured using near-infrared spectroscopy (NIRS) devices (Moxy Monitor)-in key muscle groups (intercostal, quadriceps, and triceps surae).

Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) and the 30-Second Chair Stand Test (30CST). Additional variables including inspiratory and expiratory pressures, pulmonary function (FEV1/FEV6), heart rate variability, dyspnea, lower limb fatigue, and quality of life (COPD Assessment Test) will also be recorded.

The intervention consists of 20 hospital-based sessions over four weeks (five sessions per week). The protocol is designed to reflect real clinical settings and aims to provide evidence for the feasibility, safety, and functional relevance of combining respiratory and musculoskeletal rehabilitation strategies in COPD patients.

Вмешательства

  • Поведенческое Combined respiratory physiotherapy and cardiovascular-strength training program
    20-session supervised hospital-based program including respiratory physiotherapy, aerobic training (guided by Borg scale and HR monitoring), and strength training using progressive loads (based on 1RM). Duration: 4 weeks (5 sessions/week).

Первичные конечные точки

  • Change in muscle oxygen saturation (%) [Срок оценки: From baseline to end of intervention (4 weeks)]
Вторичные конечные точки (7)
  • Distance covered in 6-Minute Walk Test (6MWT) [Срок оценки: From baseline to after the 4-week intervention]
  • Number of repetitions in the 30-Second Chair Stand Test [Срок оценки: From baseline to after the 4-week intervention]
  • Perceived dyspnea and lower limb fatigue (Borg Scale) [Срок оценки: From baseline to after the 4-week intervention]
  • Maximal inspiratory and expiratory pressures (Pimax and Pemax) [Срок оценки: From baseline to after the 4-week intervention]
  • FEV1/FEV6 ratio (portable COPD Vitalograph) [Срок оценки: From baseline to after the 4-week intervention]
  • Heart rate variability and max/min heart rate (Polar system + Kubios HRV) [Срок оценки: From baseline to after the 4-week intervention]
  • Quality of life (COPD Assessment Test - CAT) [Срок оценки: From baseline to after the 4-week intervention]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Clinical diagnosis of COPD
  • Medically cleared for physical exercise

Критерии исключения

  • Decompensated heart failure or exercise-limiting comorbidities
  • Cognitive impairment or legal incapacity to consent
  • Inability to perform physical tasks

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Португалия · 1 центр
  • Unidade Local de Saúde do Alto Alentejo (ULSAALE), Hospitals of Portalegre and Elvas, Port — Portalegre

Идентификаторы

NCT: NCT06968273 · 020525

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗