ClinicalTrials.gov record NCT07033715

Exercise in Hereditary ATTR (ATTRv) Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationPortugal
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized study compares a 12-week supervised exercise program with no exercise in people with hereditary transthyretin (ATTRv) amyloidosis. It measures physical outcomes (muscle strength, walking distance, body composition) and mental-health scores before and after the program. The exercise sessions are supervised, 60 minutes long, three times per week.

What it is studying. The study tests the effects of a 12-week supervised, mixed exercise program (cardiorespiratory, resistance, flexibility, and neuromotor activities) on physical fitness measures and mental-health scores in people with hereditary ATTR (ATTRv) amyloidosis.

What the researchers hope to learn. Scientific goals: to add evidence about the effects of exercise in people with hereditary ATTR (ATTRv) amyloidosis, including those receiving newer therapies; to assess physical outcomes (knee-extensor strength, grip strength, 6-minute walking distance, body mass index, weight and body composition measures) and mental-health using a validated questionnaire; and to raise awareness about active lifestyle and health-related quality of life in this patient community.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • Exercise

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If assigned to the exercise group, you would take part in a supervised 12-week program with three 60-minute sessions per week that include cardiorespiratory and resistance exercises plus flexibility and balance/neuromotor activities. Exercise intensity is gradually increased and monitored each session using the Borg perceived exertion scale aiming for about 12–13. You will have assessments at the start and immediately after 12 weeks: knee extensor and handgrip strength, a 6-minute walk test, body measurements (weight, BMI, fat-free mass, fat mass, body water) and a mental-health questionnaire. People in the control group will not participate in the 12-week exercise program.

How the study is structured. This is an interventional, randomized, parallel-group study with no masking. Participants are randomly assigned to either a 12-week supervised exercise program or to a control group that does not take part in the program. Physical and mental-health measures are taken at the start (baseline) and immediately after the 12-week period.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Portugal. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 1, 2024
Primary completion
Sep 30, 2025 (estimated)
Study completion
Sep 30, 2026 (estimated)
Target enrollment
42 participants (estimated)
Last updated on registry
Jun 24, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Maia
Principal investigator
Cláudia Barata, Principal Investigator
University of Maia

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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