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Набор по приглашению NCT07495410

Anderson-Fabry Disease Fitness Improvement Training: A-FAD-FIT

Без фазы С лечением Fabry Disease

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: Physiotherapy exercise programe.
Кому может быть актуально
Состояния в реестре: Fabry Disease. 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
Чехия
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 study will evaluate whether a 12-week physiotherapy and exercise program can improve physical function and quality of life in patients with Anderson-Fabry disease. Participants will complete assessments before and after the program. The intervention includes regular exercise sessions using body weight, resistance bands, and gradual increases in daily physical activity. The study is intended to determine whether a structured physiotherapy program is feasible and potentially beneficial for people living with Anderson-Fabry disease.

Подробное описание

Anderson-Fabry disease is a rare X-linked lysosomal storage disorder associated with multisystem involvement, reduced exercise tolerance, fatigue, pain, and impaired quality of life. Evidence regarding the effects of structured physiotherapy and exercise interventions in this patient population remains limited.

The aim of this study is to evaluate the feasibility and potential clinical benefit of a 12-week targeted physiotherapy intervention in patients with Anderson-Fabry disease. Participants will undergo baseline and post-intervention assessment focused on physical fitness, functional performance, and patient-reported outcomes.

The intervention will consist of 45-minute exercise sessions performed three times per week over 12 weeks. The program will combine aerobic and strengthening exercise using body weight and resistance bands and will include a gradual increase in daily step count. Adherence to the intervention will be monitored throughout the study.

The study is intended to assess whether a structured physiotherapy program may improve physical function and quality of life in patients with Anderson-Fabry disease and to provide data to support future rehabilitation recommendations in this population.

Вмешательства

  • Поведенческое Physiotherapy exercise programe
    A 12-week physiotherapy and exercise program consisting of 45-minute sessions performed three times per week and gradual increase in daily step count by approximately 10 percent every 2 weeks. The intervention combines aerobic and strengthening components, including body weight exercises and resistance band training, together with counting of daily steps. Adherence is monitored using exercise diaries and regular follow-up during therapy sessions.

Первичные конечные точки

  • Change in cardiorespiratory fitness [Срок оценки: Baseline and after 12 weeks]
Вторичные конечные точки (8)
  • Change in muscle strength [Срок оценки: Baseline and after 12 weeks]
  • Change in functional capacity measured by the 6-minute walk test [Срок оценки: Baseline and after 12 weeks]
  • Change in functional performance measured by the 30-second chair stand test [Срок оценки: Baseline and after 12 weeks]
  • Change in respiratory function [Срок оценки: Baseline and after 12 weeks]
  • Change in health-related quality of life [Срок оценки: Baseline and after 12 weeks]
  • Change in anxiety and depressive symptoms [Срок оценки: Baseline and after 12 weeks]
  • Change in self-reported physical activity [Срок оценки: Baseline and after 12 weeks]
  • Change in body composition [Срок оценки: Baseline and after 12 weeks]

Критерии участия

Критерии включения

  • Diagnosis of Anderson-Fabry disease
  • Age 18 years or older
  • Followed at a participating clinical center
  • Able to understand study procedures and provide informed consent
  • Clinically stable and considered suitable for participation in a physiotherapy and exercise program

Критерии исключения

  • Acute deterioration in health status at the time of enrollment
  • Medical contraindication to exercise testing or participation in the exercise program
  • Severe comorbidity preventing safe participation in the intervention
  • Inability to comply with the study procedures or complete follow-up assessments

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

Чехия · 1 центр
  • General University Hospital — Prague

Идентификаторы

NCT: NCT07495410 · A-FAD-FIT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗