Effects of a 12-week Exercise Intervention on Physical and Mental Health in Hereditary ATTR (ATTRv) Amyloidosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Strength of the knee extensors
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ATTRv Amyloidosis patients living in Portugal;
- •Disease stage 1 or 2;
- •No medical contraindication for exercising;
- •Ability to provide informed consent.
Exclusion Criteria
- •Having undergone a liver transplant in the past 6 months.
Outcomes
Primary Outcomes
Strength of the knee extensors
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
- Mental health(Mental health will be assessed at baseline and immediately after the 12-week exercise intervention.)
Investigators
Cláudia Barata
Principal Investigator
University of Maia