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Идёт набор NCT06061770

Comparison of the Effectiveness of an Adapted Physical Activity Program in a Dedicated Structure to a Self-program in Patients in Chronic Phase of a Stroke

Без фазы С лечением Stroke

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: Adapted physical activity program, Adapted physical activity self-program.
Кому может быть актуально
Состояния в реестре: Stroke. 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is a prospective, randomized, controlled, two parallel arms, single-blind pilot study. In this design, all included patients in the chronic phase of a stroke will receive both modes of physical activity. This study includes patients over 18 years of age with spastic hemiparesis sequelae of a first unilateral hemispheric stroke older than 6 months and able to walk for 6 minutes. The non-inclusion criteria were the inability to walk without human assistance (with or without technical aids), the existence of cognitive disorders compromising informed consent, in particular the inability to understand the objective and the modalities of the protocol, the inability to communicate with the examiners, and the presence of an additional neurological disorder or a pathology contraindicating the practice of physical activity. The primary endpoint is based on daily activity measurement by measuring the number of steps per day, collected over the duration of the study, via a Stepwatch™ device. Secondary end points involve a written physical activity report, assessment of walking ability (via walking-test 6, heart rate, and blood pressure), a measure of perceived exertion, stroke-specific quality of life, balance, and motivation to perform physical activity.

Вмешательства

  • Другое Adapted physical activity program
    Rehabilitation
  • Другое Adapted physical activity self-program
    Rehabilitation

Первичные конечные точки

  • Daily activity measurement [Срок оценки: through study completion]
Вторичные конечные точки (9)
  • the rate physical activities in Written report [Срок оценки: through study completion]
  • 6-minute walk test (6MWT) [Срок оценки: at inclusion Day and at the 13th week (and the 26th week for one group only)]
  • Measurement of heart rate at rest and after 6-minute walk test [Срок оценки: at inclusion Day and at the 13th week (and the 26th week for one group only)]
  • Measurement of systolic blood pressure at rest and after 6-minute walk test [Срок оценки: at inclusion Day and at the 13th week (and the 26th week for one group only)]
  • Borg Rating Scale of Exertion [Срок оценки: at inclusion Day and at the 13th week (and the 26th week for one group only)]
  • Stroke Specific Quality of Life scale (SS-QoL) [Срок оценки: at inclusion Day and at the 13th week (and the 26th week for one group only)]
  • Berg Balance Scale (BBS) [Срок оценки: at inclusion Day and at the 13th week (and the 26th week for one group only)]
  • Activity-specific Balanced Confidence scale (ABC scale) [Срок оценки: at inclusion Day and at the 13th week (and the 26th week for one group only)]
  • Behavioral regulation in exercise questionnaire [Срок оценки: at inclusion Day and at the 13th week (and the 26th week for one group only)]

Критерии участия

Критерии включения

  • Age greater than 18 years
  • Left or right spastic hemiparesis after a first hemorrhagic or ischemic unilateral stroke older than 6 months
  • Walking possible for 6 minutes

Критерии исключения

  • Inability to walk without human assistance (with or without technical aids)
  • Cognitive impairment that compromises informed consent, including inability to understand the purpose and terms of the protocol
  • Inability to communicate
  • Presence of an additional neurological disorder
  • Medical conditions that contraindicate physical activity, such as an unbalanced cardiovascular or respiratory condition
  • Concurrent participation in another clinical research project

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
Простое слепое
Основная цель
Профилактика

Центры проведения

Франция · 1 центр
  • Médecine Physique et de Réadaptation, CHU Hôpital Sainte Marguerite — Marseille

Публикации

  • Satger E, Prieur-Blanc N, Viton JM, Auquier P, Bensoussan L, Cotinat M. Effectiveness of an institution-based adapted physical activity programme versus a home-based self-management programme for chronic poststroke adults: protocol for a randomised controlled study. BMJ Open. 2024 Jul 20;14(7):e084688. doi: 10.1136/bmjopen-2024-084688. PMID 39032927

Идентификаторы

NCT: NCT06061770 · RCAPHM21_0439

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗