Exercise in Hereditary ATTR (ATTRv) Amyloidosis

University of Maia

Status: Enrolling

Conditions: Amyloidosis, Hereditary, Transthyretin-Related

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07033715

212/2024

2023.00324.BD (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

42 participants in 2 patient groups

Exercise

Experimental group

Description:

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

Treatment:

Other: Exercise

Control

No Intervention group

Description:

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