- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02895464
Feasibility of Home-based Preoperative Exercise in Older People
Preoperative Home-based Exercise in Older People Before Colorectal Surgery - a Feasibility Study
Обзор исследования
Подробное описание
The feasibility study will be conducted in order to evaluate the study design of a future RCT. Feasibility data will eg. consist of study flow description, number of eligible participants, included participants, patients and instructors satisfaction with the intervention, training compliance, reasons for drop-outs, and adverse events.
Patients waiting for colorectal surgery will be recruited and included after informed consent. Physical and respiratory function will be assessed at the hospital before the intervention, the day before surgery and the day before discharge. Data on postoperative complications, length of stay and mortality will be collected during the hospital stay. At baseline and six months after surgery, the participants will receive three questionnaires about level of independence in daily living, physical activity and health related quality of life. The intervention will be performed in the older person's home and consists of a combination of high-intensity respiratory training and individually adjusted functional exercise. Both groups will receive physical activity advice and malnutrition will be screened to optimize their nutritional status.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Stockholm, Швеция, 11883
- Stockholm South General Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age above 70, understand and speaks the Swedish language. Surgery due to cancer
Exclusion Criteria:
- Health status that contradicts participation in the study such as unstable heart disease or severe orthopaedic conditions that prohibits training and severe systematic illness.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Exercise group
The sessions will be led by a physiotherapist, in the older person's home.
The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day).
The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor.
This will be combined with functional task-exercises.
The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery.
During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.
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The sessions will be led by a physiotherapist, in the older person's home.
The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day).
The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor.
This will be combined with functional task-exercises.
The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery.
During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.
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Другой: Control group
The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity.
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The sessions will be led by a physiotherapist, in the older person's home.
The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day).
The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor.
This will be combined with functional task-exercises.
The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery.
During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Recruitment rate
Временное ограничение: Six months
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Number of participants included from eligible patients
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Six months
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Exercise compliance
Временное ограничение: At the end of the intervention, after 2-4 weeks
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Number of sessions attended out of planned sessions
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At the end of the intervention, after 2-4 weeks
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Acceptability
Временное ограничение: At the end of the intervention, after 2-4 weeks
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Patients and instructors satisfaction with the intervention measured with a survey
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At the end of the intervention, after 2-4 weeks
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Adverse events
Временное ограничение: During the intervention, after 1-4 weeks
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Musculoskeletal-related events , cardiovascular episodes, falls and health care use
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During the intervention, after 1-4 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Six-minute walk
Временное ограничение: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Meters completed, effort estimated
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Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Inspiratory muscle strength
Временное ограничение: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Chair-stand 30-sec
Временное ограничение: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Number
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Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Walking speed (hab/max)
Временное ограничение: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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10 meters
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Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Postoperative complications
Временное ограничение: Within the first 30 days of surgery
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Clavien-Dindo, Delirium, Mortality
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Within the first 30 days of surgery
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Length of stay
Временное ограничение: At discharge, 2-4 weeks after baseline
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At discharge, 2-4 weeks after baseline
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Discharge destination
Временное ограничение: At discharge, 2-4 weeks after baseline
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Care level after discharge from hospital (Home/Geriatric Clinic/Nursing Home)
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At discharge, 2-4 weeks after baseline
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Соавторы и исследователи
Спонсор
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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
Дополнительные соответствующие термины MeSH
- Заболевания пищеварительной системы
- Новообразования
- Новообразования по локализации
- Желудочно-кишечные новообразования
- Новообразования пищеварительной системы
- Желудочно-кишечные заболевания
- Заболевания толстой кишки
- Кишечные заболевания
- Новообразования кишечника
- Заболевания прямой кишки
- Колоректальные новообразования
Другие идентификационные номера исследования
- LS1311-1462
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. .