Exercise in Hereditary ATTR (ATTRv) Amyloidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ATTRv Amyloidosis patients living in Portugal;
Disease stage 1 or 2;
No medical contraindication for exercising;
Ability to provide informed consent.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Other interventionThe 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...).
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: ExerciseExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Strength 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.2
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.3
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.4
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.Secondary outcomes
1
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.Other outcomes
1
Health-related quality of life (HRQoL)
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).
Time frame
HRQoL will be assessed at baseline and immediately after the 12-week exercise intervention.Sponsors and contacts
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Source ClinicalTrials.gov