Идёт набор NCT05939999

Effects of Elastic Tape on Pulmonary Rehabilitation of Patients with Chronic Obstructive Pulmonary Disease

Без фазы С лечением Chronic Obstructive Pulmonary Disease

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: Experimental: Elastic tape (ET), Sham Comparator: Sham (SH).
Кому может быть актуально: Состояния в реестре: Chronic Obstructive Pulmonary Disease. Базовые параметры: Без ограничений · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бразилия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Evaluate the effect of the use of elastic tape in chest wall and abdomen in the physical capacity, psychosocial distress levels, quality of life and anxiety, and depression symptoms of individuals with moderate to very severe chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation.

Подробное описание

Individuals will be evaluated on two non-consecutive days (7 days apart). On the first visit, wil be obtained: clinical and anthropometric data and assessed clinical control \[COPD Assessment Test™(CAT)\], health-related quality of life \[Chronic Respiratory Questionnaire (CRQ)\], and anxiety and depression levels \[Hospital Anxiety and Depression Scale (HADS)\]. Patients will also perform a complete pulmonary function test. After, the volunteers will receive a triaxial accelerometer to assess their physical activity level (PAL) and will be instructed to return after seven days. On the second visit, patients will undergo the Incremental Shuttle Walking Test (ISWT), and the Endurance Shuttle Walking Test (ESWT), without ET.

After the assessments, the individuals will be randomized. Randomization will be computer generated (www.randomization.com) by an investigator who will not be involved in individual recruitment, evaluation, or intervention. The allocation of individuals will be secret using consecutive numbered, sealed, and opaque envelopes (concealed allocation). Initial and post-intervention assessments will be performed by an investigator who will not be involved in the recruitment, evaluation, or intervention. After inclusion, individuals will start a pulmonary rehabilitation (PR) program for eight weeks; twice a week, individuals in the ET group will have the tape applied at the beginning of each session and removed at the end. After completing the 8-week PR period, individuals will undergo the same tests performed in two visits.

Вмешательства

Другое Experimental: Elastic tape (ET)
The elastic tape will be allocated in the chest wall and abdomen of individuals and will be used during the 8 weeks of rehabilitation protocol.
Другое Sham Comparator: Sham (SH)
The micropore tape will be allocated in the chest wall and abdomen of individuals and will be used during the 8 weeks of rehabilitation protocol.

Первичные конечные точки

Functional Exercise Capacity: The total time reached in the Endurance Shuttle Walking Test (ESWT) [Срок оценки: Change from baseline at 8 weeks of intervention.]

Вторичные конечные точки (3)

Clinical Control: COPD Assessment Test™ (CAT) is a specific questionnaire for COPD that assesses the impact of the symptoms of the disease [Срок оценки: Change from baseline at 8 weeks of intervention.]
Symptoms of Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS): The questionnaire was developed to identify symptoms of anxiety and depressive mood. [Срок оценки: Change from baseline at 8 weeks of intervention.]
Health-related Quality of Life: was assessed by using the Chronic Respiratory Questionnaire (CRQ) [Срок оценки: Change from baseline at 8 weeks of intervention.]

Критерии участия

Критерии включения

Moderate to very severe COPD diagnosis according to Global Iniciative for Chronic Obstructive Lung Disease (GOLD) 2020
Clinical stability (i.e., no exacerbations for at least 30 days)
Male
Non-obese (BMI ≤29.9 kg/m2)
No musculoskeletal limitation
Not included in a pulmonary rehabilitation program in the last 6 months.
Do not perform home oxygen therapy