Exercise in Hereditary ATTR (ATTRv) Amyloidosis

NCT07033715 | Recruiting

• 2 other identifiers: 212/20242023.00324.BD
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyloidosis, Hereditary, Transthyretin-Related

Keywords

ATTRv; exercise; physical fitness; mental health; HRQoL

Outcome Measures

Primary Outcomes (8)

• Strength of the knee extensors

  The strength of the knee extensors (N) will be assessed with a handheld strength device (DynaMo, VALD Performance).

  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).

  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).

  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.

  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).

  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).

  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).

  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).

  Body water will be assessed at baseline and immediately after the 12-week exercise intervention.

Secondary Outcomes (1)

• Mental health

  Mental health will be assessed at baseline and immediately after the 12-week exercise intervention.

Other Outcomes (1)

• Health-related quality of life (HRQoL)

  HRQoL will be assessed at baseline and immediately after the 12-week exercise intervention.

Study Arms (2)

Exercise

EXPERIMENTAL

Participants will be enrolled in a 12-week supervised exercise intervention.

Other: Exercise

Control

NO INTERVENTION

Participants will not be enrolled in the 12-week exercise program.

Interventions

Exercise OTHER

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...).

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ATTRv Amyloidosis patients living in Portugal;
• Disease stage 1 or 2;
• No medical contraindication for exercising;
• Ability to provide informed consent.

You may not qualify if:

• \- Having undergone a liver transplant in the past 6 months.

Sponsors & Collaborators

• University of Maia: lead

Study Sites (1)

University of Maia

Maia, Porto District, 4475-690, Portugal

RECRUITING

MeSH Terms

Conditions

Amyloidosis, Hereditary, Transthyretin-Related; Motor Activity; Psychological Well-Being

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• João L. Viana, PhD

  University of Maia

  STUDY DIRECTOR

Central Study Contacts

Cláudia F. Barata, PhD

CONTACT

+351915381161; claudiapfb19@gmail.com

João L. Viana, PhD

CONTACT

D011290@umaia.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: June 24, 2025
• Study Start: October 1, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)