Exercise Therapy in Mental Disorders-study
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: High intensity training (HIT).
- Кому может быть актуально
- Состояния в реестре: Schizophrenia and Related Disorders, Bipolar Disorder. Базовые параметры: от 16 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
- Норвегия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
The study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder. The overall aim is to determine which of the two is superior in a long-term perspective.
Подробное описание
Background: Patients with severe mental disorders (SMD), including schizophrenia spectrum and bipolar disorders, frequently experience suboptimal treatment effectiveness resulting in disabling residual symptoms and cognitive challenges, and have elevated mortality risk amounting to 15-20 years of shortened life expectancy compared to the general population.
Cardiovascular disease (CVD) is a major contributor in this regard. Exercise in general improves cognitive functioning, negative symptoms, quality of life, and reduces the risk of CVD. High intensity training (HIT) has been shown to be feasible for persons with SMD, but attrition and noncompliance are substantial and likely to limit the effectiveness of HIT. A less strenuous HIT could increase adherence to the intervention, which might compensate for a slightly lower efficacy compared to standard HIT. Our study will compare standard 4x4-min HIT to a 4-min single-bout HIT session, as well as explore exercise effects on basic processes in the body. Methods: Patients with schizophrenia spectrum and bipolar disorders are eligible for participation, and those included will be randomized to 26 weeks of either 1) Standard 4 x 4 min HIT at treadmill, or 2) Short 1 x 4 min HIT at treadmill. To reduce dropout, the intervention will usually be delivered in group format, and conducted under the supervision of a physical therapist in collaboration with a postdoctor. The research group has a stable staff with research nurses, biostatisticians and researchers that will secure the dayto- day conductance of the project, including psychometric assessments, drawing of and biobanking of blood, as well as data collection and storing. Measures: Mental and cognitive symptoms, quality of life, motivation, Peak oxygen uptake (V
Вмешательства
- Другое High intensity training (HIT)
Please see information already included in the arm descriptions.
Первичные конечные точки
- Adherence [Срок оценки: 26 weeks]
Вторичные конечные точки (12)
- Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score [Срок оценки: 4, 12, 26 and 52 weeks from baseline]
- Change of the Calgary Depression Scale in Schizophrenia score [Срок оценки: 4, 12, 26 and 52 weeks from baseline]
- Change of the Clinical Global Impression (CGI) score [Срок оценки: 4, 12, 26 and 52 weeks from baseline]
- Change of the Global Assessment of Funtioning (GAF) score [Срок оценки: 4, 12, 26 and 52 weeks from baseline]
- Change of quality of life (QOL10) score [Срок оценки: 4, 12, 26 and 52 weeks from baseline]
- Change of the International Physical Activity Questionaire (IPAQ) score [Срок оценки: 4, 12, 26 and 52 weeks from baseline]
- Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score [Срок оценки: 4, 12, 26 and 52 weeks from baseline]
- Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score [Срок оценки: 4, 12, 26 and 52 weeks from baseline]
- Change of the Difficulties in Emotion Regulation (DERS) score [Срок оценки: 4, 12, 26 and 52 weeks from baseline]
- Change in heart rate (beats per minute) [Срок оценки: 4, 12, 26 and 52 weeks from baseline]
- Change of maximal oxygene extraction (VO2max) [Срок оценки: 4, 12, 26 and 52 weeks from baseline]
- Change of level of inflammatory markers in blood [Срок оценки: 4, 12, 26 and 52 weeks from baseline]
Критерии участия
Критерии включения
- ICD-10 schizophrenia-spectrum disorder (F2)
- ICD-10 bipolar disorder (F3)
- Capacity to provide informed consent.
Критерии исключения
- Contra-indication for exercise training and testing according to the American College of Sports Medicine specifications
- Life threatening or terminal medical conditions
- Not able to carry out intervention or test procedures
- Current pregnancy
- Mothers less than 6 months post-partum.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Норвегия · 1 центр
- Haukeland University Hospital — Bergen
Идентификаторы
NCT: NCT06313918 · REK nr. 428096