- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04314921
10-week Yoga Practice Effect on Cognitive and Motor Function in Older Adults (BDNF)
10-week Yoga Practice Effect in Older Adults
Thirty-three healthy elderly people, who were classified into two age groups, participated in this study. All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing. In the experimental group, participants (n = 18) had to participate in 10 weeks of yoga classes. In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.
Experimental measurements: Brunel, PSS-14 and HAD questionnaires
Обзор исследования
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Kaunas, Литва, 44221
- Lithuanian Sports Unviersity
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- age, from 60 years old
- a statement by a local family physician about general good physical health
- never tired to practice yoga before
Exclusion Criteria:
- cardiovascular diseases
- musculoskeletal system diseases (osteoporosis, osteochondrosis, hernias)
- neurodegenerative diseases
- oncological diseases
- glaucoma
- injuries and surgeries in last 3 years
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 10-week Yoga
Eighteen healthy elderly people, who were classified into two age groups, participated in this study.
All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing.
In the experimental group, participants (n = 18) had to participate in 10 weeks of yoga classes.
In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.
All experimental group subjects participated in Himalayan yoga classes, which lasted 10 weeks: 2 times per week, 90 min per session.
Yoga classes were conducted by 16-year-old qualified yoga instructor from Yoga Academy, Kaunas.
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10-week yoga sessions, 2 times per week, 90 min per session.
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Без вмешательства: Control
In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Brunel mood scale (BRUMS)
Временное ограничение: 10 weeks
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The Lithuanian translated version of the Brunel Mood Scale (BRUMS) was used in the present study.
It was based on the originally developed to serve as a brief measure of mood before and after yoga intervention.
The BRUMS (1) scale has 24 items arranged into six subscales: anger, confusion, depression, fatigue, tension and vigor.
Each subscale has a numerical rating scale (0 = not at all, 1 = a bit, 2 = moderate, 3 = enough; 4 = extremely) from which research participant select the one best represents at that time.
The results within subscale is summed and a score range from 0 to 16
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10 weeks
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Hospital anxiety and depression scale (HADS)
Временное ограничение: 10 weeks
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To determine the level of anxiety and depression of subjects was used HADS scale.
The scale consists of totally 14 questions with the answers valued from 0 to 3. Half of questions addressed to estimate anxiety and rest - depression.
The total scoring and conclusion for the both categories of questions: 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); 11-21 = Abnormal (case)
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10 weeks
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Perceived stress scale -14
Временное ограничение: 10 weeks
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The purpose of this scale is to assess the degree of stress in subjects' lives.
It consists of questions about the frequency of feeling and thoughts during the past time period.
Potential answers: 0-never; 1-almost never; 2-sometimes; 3-fairly often and 4-very often.
The scores are obtained by reversing the scores on the four positive items: for example, 0=4, 1=3, 2=2, etc. and then summing across all items.
Scores for the 14-item form range from 0 to 56, with higher scores indicating greater perceived stress
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10 weeks
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Human Free BDNF
Временное ограничение: 10 weeks
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Venous blood samples from median antecubital vein were collected in 5 ml vacuum tubes with a gel separator and was separated by centrifugation (15 min at 1200g) to make blood serum.
Samples were aliquoted and stored at -800C until analysis.
The serum concentration of Human Free BDNF was measured using an enzyme-linked immunoassay kit (R&D Systems, Minneapolis, USA)
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10 weeks
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Measurement of cognitive functions
Временное ограничение: 10 weeks
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Automated Neuropsychological Assessment Metrics Version 4 (ANAM-4; Vista Life, USA) was used to measure neurocognitive skills: mental flexibility, verbal working memory, inhibition control, visuospatial processing.
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10 weeks
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Psychomotor function evaluation
Временное ограничение: 10 weeks
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Participants were assessed by Dynamic Parameter Analyzer (DPA-1).
Its measure motor functions: accuracy, reaction speed-accuracy.
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10 weeks
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Heart rate variability
Временное ограничение: 10 weeks
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R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).
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10 weeks
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Balance procedure
Временное ограничение: 10 weeks
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Postural sway activity was measured by a posturography method with a single piezoelectric force plate (Kistler, Slimline System 9286, Switzerland).
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10 weeks
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Соавторы и исследователи
Спонсор
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 (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- LithuanianSportsU-3
Планирование данных отдельных участников (IPD)
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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. .