Exercise in Hereditary ATTR (ATTRv) Amyloidosis

Официальное название

Effects of a 12-week Exercise Intervention on Physical and Mental Health in Hereditary ATTR (ATTRv) Amyloidosis

Обзор

This study aims to explore the effects of a 12-week exercise intervention on the physical and mental health of people living with Hereditary ATTR (ATTRv) Amyloidosis, a rare genetic disease caused by mutations in the transthyretin gene, leading to the deposition of amyloid fibrils in nerves and organs.

Подробное описание

Considering that few studies to date have explored the effects of exercise in ATTRv Amyloidosis, this study aims to increase the existing evidence in this under-researched area. Besides, the existing research was performed with liver transplanted patients and focused exclusively on physical fitness outcomes. Therefore, we aim to include those patients who are currently receiving new therapies and extend research to the mental benefits of exercising, questioning whether exercise can ease the mental burden of living with such a debilitating disease. This research also seeks to raise awareness among patients and healthcare professionals about the importance of an active lifestyle in improving HRQoL in this community.

Вмешательства

• Другое Exercise
  The exercise sessions will have a frequency of 3 times a week and a duration of 60 minutes per session. Exercise intensity will be gradually increased throughout the program and will be monitored every session using Borg's Rated Perceived Exertion scale, aiming at levels of 12-13 ("fairly light to somewhat hard"). The program will be mainly composed of cardiorespiratory exercises and resistance exercises. It will also comprise flexibility exercises to improve joint range of motion and neuromotor

Первичные конечные точки

• Strength of the knee extensors [Срок оценки: Strength of the knee extensors will be assessed at baseline and immediately after the 12-week exercise intervention.]
• Grip strength [Срок оценки: Grip strength will be assessed at baseline and immediately after the 12-week exercise intervention.]
• Walking capacity [Срок оценки: Walking capacity will be assessed at baseline and immediately after the 12-week exercise intervention.]
• Body mass index [Срок оценки: Body mass index will be assessed at baseline and immediately after the 12-week exercise intervention.]
• Weight [Срок оценки: Weight will be assessed at baseline and immediatly after the 12-week exercise intervention.]
• Fat free mass [Срок оценки: Fat free mass will be assessed at baseline and immediately after the 12-week exercise intervention.]
• Fat mass [Срок оценки: Fat mass will be assessed at baseline and immediately after the 12-week exercise intervention.]
• Body water [Срок оценки: Body water will be assessed at baseline and immediately after the 12-week exercise intervention.]

Вторичные конечные точки (1)

• Mental health [Срок оценки: Mental health will be assessed at baseline and immediately after the 12-week exercise intervention.]

Критерии участия

Критерии включения

• ATTRv Amyloidosis patients living in Portugal;
• Disease stage 1 or 2;
• No medical contraindication for exercising;
• Ability to provide informed consent.

Критерии исключения

\- Having undergone a liver transplant in the past 6 months.

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

Поддерживающая терапия

Центры проведения

Португалия · 1 центр

• University of Maia — Maia

Идентификаторы

NCT: NCT07033715 · 212/2024 · 2023.00324.BD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗