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Recruiting NCT07033715

Exercise in Hereditary ATTR (ATTRv) Amyloidosis

No phase Interventional Amyloidosis, Hereditary, Transthyretin-Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: Amyloidosis, Hereditary, Transthyretin-Related. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of a 12-week Exercise Intervention on Physical and Mental Health in Hereditary ATTR (ATTRv) Amyloidosis

Overview

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.

Interventions

  • Other Exercise
    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

Primary outcome measures

  • 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.]
  • Grip strength [Time frame: Grip strength will be assessed at baseline and immediately after the 12-week exercise intervention.]
  • Walking capacity [Time frame: Walking capacity will be assessed at baseline and immediately after the 12-week exercise intervention.]
  • Body mass index [Time frame: Body mass index will be assessed at baseline and immediately after the 12-week exercise intervention.]
  • Weight [Time frame: Weight will be assessed at baseline and immediatly after the 12-week exercise intervention.]
  • Fat free mass [Time frame: Fat free mass will be assessed at baseline and immediately after the 12-week exercise intervention.]
  • Fat mass [Time frame: Fat mass will be assessed at baseline and immediately after the 12-week exercise intervention.]
  • Body water [Time frame: Body water will be assessed at baseline and immediately after the 12-week exercise intervention.]
Secondary outcome measures (1)
  • Mental health [Time frame: Mental health will be assessed at baseline and immediately after the 12-week exercise intervention.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Portugal · 1 center
  • University of Maia — Maia

Identifiers

NCT: NCT07033715 · 212/2024 · 2023.00324.BD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗