Status:
RECRUITING
Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cardiac Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to assess the beneficial effects of three targeted Shiatsu sessions compared to "comfort" Shiatsu on symptoms in patients with severe cardiac amyloidosis. Specifically, ...
Detailed Description
IAmyloidosis leads to a wide range of disorders, including vascular, cardiac, neuropathic, digestive, renal, and others. These impairments significantly affect patients' quality of life, autonomy, and...
Eligibility Criteria
Inclusion
- Age ≥ 18 years ;
- Patient with :
- Transthyretin of genetic origin (TTR) ;
- Transthyretin of non-mutated origin (WT) ;
- Light Chain (AL);
- Membership of a social security scheme, beneficiary or beneficiary's beneficiary (excluding AME);
- Written patient consent.
- Score greater than or equal to 3 on the EESE-R questionnaire (Edmonton Symptom Evaluation Scale-Revised), for at least 1 symptom among: dyspnea, digestive disorders, nausea, pain, anxiety, depression (Shiatsu and non-Shiatsu groups);
- Score global à l'EESE-R supérieur ou égal à 10 (groupes Shiatsu et sans shiatsu).
Exclusion
- Patients with orthostatic hypotension;
- Patients with bullous amyloidosis (fragile skin);
- Patients who have already received Shiatsu treatment;
- Patient with insufficient autonomy to maintain sitting position;
- Patient with insufficient autonomy to move from home to hospital;
- Participating in another interventional study, or within the exclusion period of a previous study, if applicable;
- Known pregnancy or breast-feeding;
- Patient under known guardianship at the time of inclusion;
- Patient under AME.
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06197165
Start Date
March 12 2024
End Date
October 1 2025
Last Update
February 6 2025
Active Locations (1)
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1
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, France, 94010