Actively Recruiting
Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-15
108
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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, the study aims to evaluate the short-term impact of a targeted Shiatsu session on neuro-cardiovascular physiological parameters and symptoms in patients with cardiac amyloidosis, in comparison to comfort Shiatsu and no Shiatsu. Additionally, the study will investigate the effects of three targeted Shiatsu sessions versus "comfort" Shiatsu and no Shiatsu on various symptoms (fatigue, sleep disturbances, pain, anxiety, depression, dyspnea, digestive disorders, nausea) and quality of life in cardiac amyloidosis patients with severe symptoms. Patient satisfaction with Shiatsu will also be evaluated, alongside an assessment of the tolerance to Shiatsu.
CONDITIONS
Official Title
Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with transthyretin amyloidosis of genetic origin (TTR), transthyretin of non-mutated origin (WT), or light chain (AL) amyloidosis
- Member of a social security scheme or beneficiary
- Provided written consent to participate
- Score of 3 or higher on the EESE-R questionnaire for at least one symptom among dyspnea, digestive disorders, nausea, pain, anxiety, or depression
- Overall EESE-R score of 10 or higher
You will not qualify if you...
- Presence of orthostatic hypotension
- Diagnosis of bullous amyloidosis with fragile skin
- Previous Shiatsu treatment
- Insufficient autonomy to maintain a sitting position
- Insufficient autonomy to travel from home to hospital
- Participation in another interventional study or within exclusion period
- Known pregnancy or breastfeeding
- Under legal guardianship at time of inclusion
- Under AME (universal medical coverage for undocumented immigrants)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, France, 94010
Actively Recruiting
Research Team
J
JULIE POMPOUGNAC, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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