University of Maia
Maia, Porto District, 4475-690, Portugal
Location status: Recruiting
Location contact
Cláudia F. Barata, PhD
CONTACT
Cláudia F. Barata, PhD
PRINCIPAL_INVESTIGATOR
João L. Viana, PhD
CONTACT
Recruiting
NCT Number: NCT07033715
Exercise in Hereditary ATTR (ATTRv) Amyloidosis
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Exercise
OtherThe 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 exercises involving motor skills (balance, agility, coordination, gait...), proprioceptive training and multifaceted activities (tai ji, yoga...).
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
Time frame: Mental health will be assessed at baseline and immediately after the 12-week exercise intervention.
Mental health will be evaluated using the Portuguese adaptation of the Mental Health Continuum-Short Form (MHC-SF), a mental-health questionnaire with 14 items that investigates respondent's emotional (3 items), social (5 items) and psychological (6 items) well-being. Each item is rated on a 6-point Likert scale, ranging from 0 (never) to 5 (everyday).
Other outcomes
-
Health-related quality of life (HRQoL)
Time frame: HRQoL will be assessed at baseline and immediately after the 12-week exercise intervention.
To assess HRQoL, the EQ-5D-3L will be used to determine patients' health state in 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2) and extreme problems (3).
Study contacts
Contact information is provided by the study sponsor or research team.
Cláudia F. Barata, PhD
CONTACT
João L. Viana, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
University of Maia
Other
Registry information
Official study title
Effects of a 12-week Exercise Intervention on Physical and Mental Health in Hereditary ATTR (ATTRv) Amyloidosis
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Jun 24, 2025
- Registry last updated
- Jun 24, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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