- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02757157
Comparison of Walking in Water and on Land in People With Chronic Obstructive Pulmonary Disease (COPD)
Determining the Metabolic Load of Walking in Water Compared to Walking on Land in People With COPD, Who Are Normal Weight and Obese, Compared to Peak Exercise Metabolic Response: a Prospective, Randomised Cross-over Pilot Trial
The purpose of this study is to evaluate the metabolic load during a single session of moderate intensity walking in water compared to walking on land (over-ground) in people with chronic obstructive pulmonary disease (COPD) who are normal weight and obese, compared with peak exercise metabolic response.
The hypothesis is that the metabolic load of walking at a moderate intensity in water will be greater than walking on land.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Horn, Нидерланды
- Centre of intergrated rehabilitation for chronic organ failure
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- diagnosis of COPD (FEV1/FVC <0.7) in a clinically stable state (no acute exacerbation of COPD within the previous 4 weeks)
- accepting of walking in water
- BMI >/= 21 kg/m2
Exclusion Criteria:
- long-term oxygen therapy
- contraindications to entering a hydrotherapy pool
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: COPD (normal weight)
People with COPD (BMI 21 kg/m2 to 29 kg/m2)
|
Participants will walk in the water for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking in water, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. Participants will walk on land for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking on land, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. |
|
Экспериментальный: COPD (obese)
People with COPD (BMI >/= 30 kg/m2)
|
Participants will walk in the water for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking in water, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. Participants will walk on land for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking on land, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Breath-by-breath oxygen consumption (VO2)
Временное ограничение: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Minute ventilation (VE)
Временное ограничение: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
Другие показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Dyspnoea, measured by the modified Borg 0-10 category ratio scale
Временное ограничение: Day of assessment during study measurement period (15 minutes)
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Day of assessment during study measurement period (15 minutes)
|
|
Exertion, measured by the modified Borg 0-10 category ratio scale
Временное ограничение: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
|
Oxygen saturation
Временное ограничение: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
|
Heart rate
Временное ограничение: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Martijn A Spruit, PhD, Centre of integrated rehabilitation for chronic organ failure
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ERS STRTF 2015 - 9368
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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