Braining - Evaluation of Acute Effects of Physical Exercise
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: Braining.
- Кому может быть актуально
- Состояния в реестре: Psychiatric Disorder. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Braining Study - Physical Exercise in Psychiatry - Evaluation of Acute Effects
Обзор
"Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurements and evaluations before and after a training period. The scientific purpose of this study is to investigate immediate and short-term effects of a booster-session of several Braining classes.
Подробное описание
"Braining" is a clinical invention that helps patients in psychiatry to start and execute physical exercise (PE) regularly in psychiatric care. The core components are basic moderate to vigorous aerobic group training sessions and motivational work led by the psychiatric staff. Braining is used as add-on treatment to regular psychiatric care and is included in the patient care plan.
In the present study, the focus is on the acute effects of a booster session of one to three Braining classes on psychiatric symptoms and biomolecular markers as well as impact on motivational factors.
Participants are recruited from the final cohort (N = 51) of the previous retrospective study, (Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety).This final cohort will be contacted to give written consent to partake in the booster session. The Braining classes each have a duration of 30 minutes and are scheduled over the course of a week.
Descriptive data on participating patients will be collected before the booster week. This will include age, gender, diagnoses, employment status. In conjunction with this, basic psychiatric and somatic examinations will be conducted.
During each Braining class, participants' activity level will be measured with a heart rate monitor to ascertain achieving moderate to vigorous intensity. Directly before and after each class, current anxiety level will be measured on a Visual Analogue Scale 0-100.
Within 30 minutes before and after one Braining class, venous blood samples (50 ml) will be taken for biomolecular markers. Blood samples include 1) inflammation markers such as high-sensitivity C-reactive protein hsCRP, 2) Brain-derived neurotrophic factor BDNF, 3) telomerase activity and 4) epigenetic markers.
Before and after the booster week, self-assessments scales for anxiety and depressive symptoms will be administered. Qualitative data on participants' experience as well as motivational factors will be collected.
Вмешательства
- Поведенческое Braining
"Braining" is a clinical invention that helps patients in psychiatry to start and execute physical exercise (PE) regularly in psychiatric care. The core components are basic moderate to vigorous aerobic group training session and motivational work led by the psychiatric staff. Braining is used as add-on treatment to regular psychiatric care and is included in the patient care plan.
Первичные конечные точки
- Anxiety Visual Analogue Scale (VAS) [Срок оценки: Pre- to post-exercise class, timeframe 2 hours]
Вторичные конечные точки (6)
- Beck Anxiety Inventory BAI [Срок оценки: Pre-intervention to post-intervention, timeframe 1 week]
- Montgomery-Åsberg Depression Rating Scale MADRS [Срок оценки: Pre-intervention to post-intervention, timeframe 1 week]
- High sensitivity C-reactive protein hsCRP [Срок оценки: Pre- to post-exercise class, timeframe 2 hours]
- Brain-derived neurotrophic factor BDNF [Срок оценки: Pre- to post-exercise class, timeframe 2 hours]
- Telomerase activity [Срок оценки: Pre- to post-exercise class, timeframe 2 hours]
- Motivational factors of continued exercise [Срок оценки: Pre-intervention to post-intervention, timeframe 1 week]
Критерии участия
Критерии включения
- Included in the retrospective study Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety and has given informed consent to participation in a Braining booster session.
Критерии исключения
- Severe psychiatric disorder such as mania and psychosis
- Medical conditions such as heart- and lung diseases where PE is contraindicated.
- Unable to understand written and spoken Swedish language.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Швеция · 1 центр
- Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest) — Stockholm
Идентификаторы
NCT: NCT06304363 · Braining booster