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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
42
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 exercises involving motor skills (balance, agility, coordination, gait...), proprioceptive training and multifaceted activities (tai ji, yoga...).
University of Maia
Maia, Porto District, Portugal
RECRUITINGStrength of the knee extensors
The strength of the knee extensors (N) will be assessed with a handheld strength device (DynaMo, VALD Performance).
Time frame: Strength of the knee extensors will be assessed at baseline and immediately after the 12-week exercise intervention.
Grip strength
Grip strength (N) will be assessed with a handheld strength device (DynaMo, VALD Performance).
Time frame: Grip strength will be assessed at baseline and immediately after the 12-week exercise intervention.
Walking capacity
Walking capacity will be assessed with the 6-minute walk test, registering the total distance covered in the test (m).
Time frame: Walking capacity will be assessed at baseline and immediately after the 12-week exercise intervention.
Body mass index
Body mass index (kg/m\^2) will be calculated from the ratio between weight and the square of height.
Time frame: Body mass index will be assessed at baseline and immediately after the 12-week exercise intervention.
Weight
Weight (kg) will be assessed with a bioelectrical impedance device (TANITA BC-545N).
Time frame: Weight will be assessed at baseline and immediatly after the 12-week exercise intervention.
Fat free mass
Fat free mass (kg) will be assessed with a bioelectrical impedance device (TANITA BC-545N).
Time frame: Fat free mass will be assessed at baseline and immediately after the 12-week exercise intervention.
Fat mass
Fat mass (%) will be assessed with a bioelectrical impedance device (TANITA BC-545N).
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Time frame: Fat mass will be assessed at baseline and immediately after the 12-week exercise intervention.
Body water
Body water (kg) will be assessed with a bioelectrical impedance device (TANITA BC-545N).
Time frame: Body water will be assessed at baseline and immediately after the 12-week exercise intervention.
Mental health
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).
Time frame: Mental health will be assessed at baseline and immediately after the 12-week exercise intervention.