Amyloidosis, Hereditary, Transthyretin-RelatedNCT07033715
Exercise in Hereditary ATTR (ATTRv) Amyloidosis
A study testing Exercise in people with Amyloidosis, Hereditary, Transthyretin-Related, run by University of Maia at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis, Hereditary, Transthyretin-Related
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ATTRv Amyloidosis patients living in Portugal;
- Disease stage 1 or 2;
- No medical contraindication for exercising;
- Ability to provide informed consent.
Who cannot join
- Having undergone a liver transplant in the past 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
João L. Viana, PhD contact
Portugal1 site, 1 recruiting
- Recruiting
University of Maia
Maia, Porto District, 4475-690
Cláudia F. Barata, PhD, +351915381161, claudiapfb19@gmail.com
João L. Viana, PhD, D011290@umaia.pt
About this study
Official title: Effects of a 12-week Exercise Intervention on Physical and Mental Health 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.
Read the 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.
- Being tested
- Exercise
- Keywords
- ATTRv, exercise, physical fitness, mental health, HRQoL
- Medical subject headings
- Amyloidosis, Hereditary, Transthyretin-Related, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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...).
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participants will be enrolled in a 12-week supervised exercise intervention. Receives: Other: Exercise |
| Control | No intervention | Participants will not be enrolled in the 12-week exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength of the knee extensors
The strength of the knee extensors (N) will be assessed with a handheld strength device (DynaMo, VALD Performance).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Body water 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).
Measured: Mental health will be assessed at baseline and immediately after the 12-week exercise intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Oct 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloidosis, Hereditary, Transthyretin-RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cláudia Barata, University of Maia
- Investigators
- João L. Viana, PhD, Study director, University of Maia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033715
- Sponsor's protocol ID
- 212/2024
- Other IDs
- 2023.00324.BD, 2023
- Status last verified
- Jun 2025
- First submitted
- 18 Apr 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will involve the collection of sensitive personal data regarding patient's physical and mental health.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-week Exercise Intervention on Physical and Mental Health in Hereditary ATTR (ATTRv) Amyloidosis
- ClinicalTrials.gov ID
- NCT07033715
- Acronym / sponsor ID
- 212/2024
- Keywords
- ATTRv, exercise, physical fitness, mental health, HRQoL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of MaiaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseParticipants will be enrolled in a 12-week supervised exercise intervention. |
| Control | No intervention | –Participants will not be enrolled in the 12-week exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ATTRv Amyloidosis patients living in Portugal;
- Disease stage 1 or 2;
- No medical contraindication for exercising;
- Ability to provide informed consent.
Key exclusion criteria (1 listed)
- Having undergone a liver transplant in the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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...). | Other | Exercise |
Primary outcome
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).
1 secondary outcome
Mental health
Time frame: Mental health will be assessed at baseline and immediately after the 12-week exercise intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No. The study will involve the collection of sensitive personal data regarding patient's physical and mental health.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
João L. Viana, PhD contact
João L. Viana, PhD study director
University of Maia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Amyloidosis, Hereditary, Transthyretin-Related, run by University of Maia at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cláudia F. Barata, PhD (+351915381161, claudiapfb19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.