Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD
24 апреля 2017 г. обновлено: Diogo Fanfa Bordin, University of Santa Cruz do Sul
Effects of Inspiratory Muscle Training on Respiratory Electromyographic Activity in Patients With COPD Participants and Non-participants of a Pulmonary Rehabilitation Program
Intended to treat disorders of the respiratory muscles can use the device Threshold IMT ® through an inspiratory muscle training (IMT) that allows training of the inspiratory muscles, the chief of these being the diaphragm which is which objectified the improvement of its function . To monitor the action of the respiratory muscles can be used several tools such as manometer that aims to assess respiratory pressures, ie, the strength of respiratory muscles, or the Surface Electromyography (sEMG) that allow evaluating the electromyographic activity of muscles analyzed. From a quantitative clinical trial, randomized and blinded, composed of 45 individuals obtained by random convenience and divided into three groups, COPD participating in a pulmonary rehabilitation program (RP) which will make TMI (TGR - Trained Group Rehabilitated), COPD does not participant in a PR program (TGNR - Trained Group not Rehabilitated) and a control group composed of healthy individuals (CG) that seek to analyze the electromyographic activity of sternocleidomastoid (SCM) and diaphragm muscle strength, lung volumes and breathing patterns before and after a period of eight weeks of TMI. Manual will also be held dynamometry to compare the grip strength of the CG, TGR and TGNR only at baseline.
Hypothesis:
- The Inspiratory Muscle Training (IMT) increases the maximal inspiratory pressure (MIP) in COPD patients regardless of whether they are enrolled in a program of pulmonary rehabilitation (PR).
- TMI alters the breathing pattern in COPD patients regardless of whether they were entered into a PR program.
- Patients with COPD who do not participate in a PR program have higher handgrip strength compared to patients who did not participate in a PR program.
- There is decreased activity of the sternocleidomastoid muscle due to increased activity in the diaphragmatic muscle fibers after a period of TMI.
- TMI in COPD patients participating in a program RP produces greater increase in MIP, the handgrip strength, improves breathing pattern and a greater reduction in the activity of the SCM muscle and diaphragm than in those who did not participate in a program RP.
- There will be a reduction in respiratory rate, heart rate, systolic and diastolic blood pressure and increased oxygen saturation at the end of the TMI.
- TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the training period.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
20
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Rio Grande do Sul
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Santa Cruz do Sul, Rio Grande do Sul, Бразилия
- Universidade de Santa Cruz do Sul
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 40 лет до 80 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Will be included in the study subjects of both sexes aged between 40 and 80 years. For the control group will participate in healthy subjects, non-smokers with normal lung function. For Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group participate COPD patients with GOLD staging II and III, participants and non-participants of a PR program respectively, where individuals not participating (GTMINR) will be those who will enter the PR program during the stipulated time of study and the participants have (GTMIR) should be included in the project for at least eight weeks, the time required for a program to provide RP's effects in COPD
Exclusion Criteria:
- Not participate in the study and Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group, individuals who do not fit the criteria for GOLD in stages II and III, which are in acute disease, presenting hemodynamic instability, aneurysm, cognitive impairment or any other co-morbidity that prevents this study. For the GC will not participate smokers, ex-smokers or who have compromised lung function, individuals participating in regular physical activity, ie three or more times per week, and no pathology that affects the cardiorespiratory system. Also excluded are those who do not sign the consent form.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Group Pulmonary Rehabilitation
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard desinsuflativo (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
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Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
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Экспериментальный: Group TMI + Pulmonary Rehabilitation
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program.
The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
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Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program.
The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
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Экспериментальный: Control Group
Inspiratory muscle training will be held three times a week for eight weeks
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Will be held inspiratory muscle training associated with a pulmonary rehabilitation program.
The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
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Экспериментальный: COPD group not rehabilitation
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Will be held inspiratory muscle training associated with a pulmonary rehabilitation program.
The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Muscle electromyographic activity of the accessory Inspiration
Временное ограничение: The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
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The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Inspiratory Muscle Training
Временное ограничение: Will be performed with frequency of three days non-consecutive week, for eight weeks
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Will be performed with frequency of three days non-consecutive week, for eight weeks
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Assessment of lung volumes
Временное ограничение: will be performed previously to the study and at the end, over eight weeks
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will be performed previously to the study and at the end, over eight weeks
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assessment of respiratory muscle strength
Временное ограничение: will be performed previously to the study and at the end, as well as weekly to adjust the pressure load, It will be evaluated over eight weeks
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will be performed previously to the study and at the end, as well as weekly to adjust the pressure load, It will be evaluated over eight weeks
|
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breathing pattern assessment
Временное ограничение: will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks
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will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Dulciane N Paiva, Doctor, University of Santa Cruz do Sul
- Главный следователь: Diogo F Bordin, Academic, University of Santa Cruz do Sul
- Директор по исследованиям: Dannuey M Cardoso, Master, University of Santa Cruz do Sul
- Директор по исследованиям: Andrea LG da Silva, Doctor, University of Santa Cruz do Sul
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 августа 2013 г.
Первичное завершение (Действительный)
1 ноября 2014 г.
Завершение исследования (Действительный)
1 января 2015 г.
Даты регистрации исследования
Первый отправленный
3 ноября 2013 г.
Впервые представлено, что соответствует критериям контроля качества
11 декабря 2013 г.
Первый опубликованный (Оценивать)
18 декабря 2013 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
25 апреля 2017 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
24 апреля 2017 г.
Последняя проверка
1 апреля 2017 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- UNISC_001
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .