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Идёт набор NCT07058389

Synergy Between Physical Activity and Outdoor Green Environments to Reduce the Intensity of Negative Symptoms in Schizophrenia.

Без фазы С лечением Schizoaffective 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: 8-week outdoor physical activity program, 8-week indoor physical activity program.
Кому может быть актуально
Состояния в реестре: Schizoaffective Disorder. Базовые параметры: 18 лет — 55 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
Франция
Следующий шаг
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Официальное название

Synergy Between Physical Activity and Outdoor Green Environments to Reduce the Intensity of Negative Symptoms in Schizophrenia: a Pilot Study.

Обзор

Physical activity appears to be a novel and original adjunctive therapeutic approach in the management of patients with schizophrenia. It may help reduce schizophrenic symptoms, act as a pro-cognitive therapy, improve quality of life, and reduce cardiovascular comorbidities. Moreover, some evidence suggests that physical activity practiced in a natural environment has even more positive effects on mental health compared to physical activity carried out indoors or in urban settings. Indeed, greater exposure to greenery is associated with a better perception of general health and with reduced levels of cortisol, anxiety, and depression. No study has yet attempted to examine the impact of physical activity in green (outdoor) spaces compared to indoor physical activity on the negative symptoms of patients suffering from schizophrenia. The aim of this study is therefore to test this hypothesis.

Вмешательства

  • Другое 8-week outdoor physical activity program
    EXT group will perform aerobic and resistance exercises with a coach in adapted physical activities on a green environment in a parc. Sessions will be typically composed as follows: * Warm-up (20 min) * Aerobic exercise (30 min) at RPE 4 to 7 on the Borg scale * Muscular strengthening (25 min) at RPE 4 to 7 on the Borg scale * Cool-down, stretching and balance (15 min) EXR group will train for 8 weeks, twice a week for 1h30, following WHO recommendation.
  • Другое 8-week indoor physical activity program
    INT group will perform aerobic and resistance exercises with a coach in adapted physical activities, inside a conventional gym. Sessions will be typically composed as follows: * Warm-up (20 min) * Aerobic exercise (30 min) at RPE 4 to 7 on the Borg scale * Muscular strengthening (25 min) at RPE 4 to 7 on the Borg scale * Cool-down, stretching and balance (15 min) INT group will train for 8 weeks, twice a week for 1h30, following WHO recommendation.

Первичные конечные точки

  • Self-evaluation of negative symptoms (SNS) questionnaire [Срок оценки: Weeks 2, 10 and 22]
Вторичные конечные точки (9)
  • Clinical global Impression (CGI) scale [Срок оценки: Weeks 2, 10 and 22]
  • Personal and social performance (PSP) scale [Срок оценки: Weeks 2, 10 and 22]
  • Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) [Срок оценки: Weeks 2, 10 and 22.]
  • VO2 max [Срок оценки: Weeks 2, 10 and 22.]
  • Maximum force [Срок оценки: Weeks 2, 10 and 22.]
  • Flexibility [Срок оценки: Weeks 2, 10 and 22.]
  • Spatio-temporal coordination [Срок оценки: Weeks 2, 10 and 22.]
  • Balance [Срок оценки: Weeks 2, 10 and 22.]
  • IPAQ questionnaire [Срок оценки: Weeks 2, 10 and 22.]

Критерии участия

Критерии включения

  • Patients with schizophrenia, aged 18 to 55 years
  • Having persistent negative symptoms (SNS), negative symptoms self-assessment scale > 7
  • Regularly monitored in the psychiatry department.
  • Have no medical contraindications to physical activity
  • Subject affiliated with or entitled to a social security system.
  • Subject having received informed information about the study and having co-signed, with the investigator, consent to participate in the study.
  • Male or female.

Критерии исключения

  • Patient unsuitable for study in the opinion of the investigator
  • Any subject with chronic joint pathologies (example: repeated sprains, patellar or ligament problems) or cardiac pathologies.
  • Any subject presenting chronic or central neurological pathologies.
  • Any subject deprived of liberty or subject to legal protection
  • Excessive consumption of alcohol (> 14 glasses per week) or caffeinated drinks (> 400 mg of coffee per day).
  • Pregnant women.
  • Subject unable to understand the purpose and conditions of the study, unable to give consent.

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
Другое

Центры проведения

Франция · 1 центр
  • CHU de Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT07058389 · 25CH062 · 2025-A00700-49

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗