Меню
Идёт набор NCT06560749

Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder

Без фазы С лечением Bipolar Disorder

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: Physical Exercise.
Кому может быть актуально
Состояния в реестре: Bipolar Disorder. Базовые параметры: 18 лет — 60 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
Бразилия
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 →

Официальное название

Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder: a Controlled and Randomized Study

Обзор

The goal of this clinical trial is to evaluate the impact of Physical Exercise (PE), as an adjuvant treatment, on the cognition of patients diagnosed with Bipolar Disorder who present cognitive impairments, as well as its impact on quality of life and functionality and its association with physiological variables. Our specific goals are: 1. Evaluate the effect of PE on the neuropsychological functions of attention, memory, verbal fluency, executive function and processing speed in patients diagnosed with BD who present cognitive impairments in these domains. 2. To evaluate the effect of PE on the quality of life and functionality of patients diagnosed with BD, as well as possible associations with cognitive functions. 3. To evaluate possible correlations between physiological variables, such as cardiorespiratory indices, strength and body composition, and improvements in cognitive functions, quality of life and functionality.

Подробное описание

The study aims to assess the impact of structured physical exercise on the cognitive function of bipolar disorder patients presenting deficits, while investigating its association to quality of life and functionality. The study will include 72 euthymic BD patients from the Bipolar Disorder Research Program (PROMAN) at the Institute of Psychiatry of the University of São Paulo Medical School, randomly distributed into two groups: 1) the experimental group will be submitted to supervised training sessions, three times per week, for 12 weeks, including aerobics and strength exercises, as well as treatment as usual (TAU); and 2) the control group will be submitted exclusively to TAU. Cognitive function, depressive and manic symptoms, quality of life and functionality will be assessed at baseline and at follow-uo (week 12), for both groups. Statistical hypothesis testing, assessing the presence of statistically significant differences between groups, pre and post intervention, should be available on the third quarter of 2025.

Вмешательства

  • Другое Physical Exercise
    Measure the impact of physical exercise in the cognition of pacients diagnosed with Bipolar Disorder

Первичные конечные точки

  • Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: Baseline, Week 4, Week 8 and Follow-up (12 weeks)]
  • Young Mania Rating Scale (YMRS) [Срок оценки: Baseline, Week 4, Week 8 and Follow-up (12 weeks)]
  • Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) [Срок оценки: Baseline only]
  • Screen for Cognitive Impairment in Psychiatry (SCIP) [Срок оценки: Baseline only]
  • Stroop Color-Word Test (Spreen and Strauss, 1998) [Срок оценки: Baseline and Follow-up (12 weeks)]
  • Verbal Fluency - F.A.S (Spreen and Strauss, 1998) [Срок оценки: Baseline and Follow-up (12 weeks)]
  • Trail Making Test (Spreen and Strauss, 1998) [Срок оценки: Baseline and Follow-up (12 weeks)]
  • Logical Memory I and II (Wechsler, 1997b) [Срок оценки: Baseline and Follow-up (12 weeks)]
  • List of Words (Wechsler, 1997a) [Срок оценки: Baseline and Follow-up (12 weeks)]
  • Cardiovascular evaluation [Срок оценки: Baseline and Follow-up (12 weeks)]
Вторичные конечные точки (2)
  • Functional Assessment Staging Tool (FAST) [Срок оценки: Baseline and Follow-up (12 weeks)]
  • The World Health Organization Quality of Life Assessment (WHOQOL) [Срок оценки: Baseline and Follow-up (12 weeks)]

Критерии участия

Критерии включения

  • Diagnosis of Bipolar disorder (BD) I and II according to DSM-5
  • Age: 18 - 55 years old
  • Complete primary education
  • Euthymic (YMRS < 8 and MADRS < 12)
  • Presence of cognitive impairments (COBRA > 14 and SCIP < 75)
  • Estimated IQ ≥ 80
  • No medication changes in the last month
  • Having been without regular PE practice for six months
  • Signature of the TCLE

Критерии исключения

  • Organic mental disorder
  • BMI > 40
  • Alcohol or drug abuse in the last 6 months
  • Use of benzodiazepines or beta-blockers in the last month

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
Двойное слепое
Основная цель
Скрининг

Центры проведения

Бразилия · 1 центр
  • Gabriel Okawa Belizario — São Paulo

Идентификаторы

NCT: NCT06560749 · 05440818.0.0000.0068

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗