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Clinical Trials in France / NCT06197165
Recruiting Not applicable

Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients

NCT06197165 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2024-03-12
Last updated
2026-01-15

Condition(s) studied

Cardiac Amyloidosis

Investigational drug(s) / intervention(s)

Targeted Shiatsu

Targeted Shiatsu: demonstrate the beneficial impact targeted Shiatsu compared with a "comfort" Shiatsu

Study 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, 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

  • EESE-R (ESAS) TOTAL SYMPTOM SCORE AT 48 HOURS AFTER THIRD SHIATSU SESSION — 31 days ± 1 day
    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).

Trial sites (1)

FacilityCityRegionStatus
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR Créteil France Recruiting

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Other trials for the same condition

Description of a Retrospective Cohort of Patients With Transthyretin Cardiac Amyloidosis (ATTR-CA) in Internal Medicine Recruiting
Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure Recruiting
Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy Recruiting
Registre HEAR, Healthcare European Amyloidosis Registry Recruiting
Prevalence of Cardiac Thrombi in Cardiac Amyloidosis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06197165 on ClinicalTrials.gov ↗ ← All trials in France