About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years ;
Transthyretin of genetic origin (TTR) ;
Transthyretin of non-mutated origin (WT) ;
Light Chain (AL);
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Targeted Shiatsu
Other interventiondemonstrate the beneficial impact targeted Shiatsu compared with a "comfort" Shiatsu
Treatment groups
Trial outcomes
Primary outcomes
EESE-R (ESAS) TOTAL SYMPTOM SCORE AT 48 HOURS AFTER THIRD SHIATSU SESSION
Description of efficacy endpoints for primary endpoint: Reduction in total ESAS symptom score at 48 hours after third shiatsu session. Questionnaire at J0 (before first session) - J2 (48 H after first session)- J16 48H (after third session) - J31 48H (15 days after third session).
Secondary outcomes
MEASUREMENT PHYSIO, SUDOSCAN, E-PATCH
Description of secondary endpoint: 20% improvement in heart rate variability measured with the e-patch. Continuous measurement \[0-48H\] after first Shiatsu session
Sponsors and contacts
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