Effects of a 12-week Exercise Intervention on Physical and Mental Health in Hereditary ATTR (ATTRv) Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Strength of the knee extensors
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ATTRv Amyloidosis patients living in Portugal;
- •Disease stage 1 or 2;
- •No medical contraindication for exercising;
- •Ability to provide informed consent.
排除标准
- •Having undergone a liver transplant in the past 6 months.
结局指标
主要结局
Strength of the knee extensors
时间窗: Strength of the knee extensors will be assessed at baseline and immediately after the 12-week exercise intervention.
The strength of the knee extensors (N) will be assessed with a handheld strength device (DynaMo, VALD Performance).
Grip strength
时间窗: Grip strength will be assessed at baseline and immediately after the 12-week exercise intervention.
Grip strength (N) will be assessed with a handheld strength device (DynaMo, VALD Performance).
Walking capacity
时间窗: Walking capacity will be assessed at baseline and immediately after the 12-week exercise intervention.
Walking capacity will be assessed with the 6-minute walk test, registering the total distance covered in the test (m).
Body mass index
时间窗: Body mass index will be assessed at baseline and immediately after the 12-week exercise intervention.
Body mass index (kg/m\^2) will be calculated from the ratio between weight and the square of height.
Weight
时间窗: Weight will be assessed at baseline and immediatly after the 12-week exercise intervention.
Weight (kg) will be assessed with a bioelectrical impedance device (TANITA BC-545N).
Fat free mass
时间窗: Fat free mass will be assessed at baseline and immediately after the 12-week exercise intervention.
Fat free mass (kg) will be assessed with a bioelectrical impedance device (TANITA BC-545N).
Fat mass
时间窗: Fat mass will be assessed at baseline and immediately after the 12-week exercise intervention.
Fat mass (%) will be assessed with a bioelectrical impedance device (TANITA BC-545N).
Body water
时间窗: Body water will be assessed at baseline and immediately after the 12-week exercise intervention.
Body water (kg) will be assessed with a bioelectrical impedance device (TANITA BC-545N).
次要结局
- Mental health(Mental health will be assessed at baseline and immediately after the 12-week exercise intervention.)
研究者
Cláudia Barata
Principal Investigator
University of Maia