Effects of Shiatsu on Symptoms and Quality of Life in Cardiac Amyloidosis Patients
Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
This study is testing whether three special Shiatsu massage sessions can help improve symptoms and quality of life for people with severe cardiac amyloidosis compared to regular comfort Shiatsu or no massage at all.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil) |
| Trial ID | NCT06197165 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of three targeted Shiatsu sessions on patients with severe cardiac amyloidosis, comparing it to 'comfort' Shiatsu and no Shiatsu. The aim is to assess the short-term impact on various symptoms such as fatigue, pain, anxiety, and quality of life. The study will also measure neuro-cardiovascular physiological parameters and patient satisfaction with the Shiatsu interventions. By incorporating Shiatsu as a complementary therapy, the research seeks to improve the management of chronic symptoms associated with amyloidosis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with cardiac amyloidosis, specifically those with transthyretin or light chain types, experiencing significant symptoms.
Not a fit: Patients with orthostatic hypotension, bullous amyloidosis, or those who have previously received Shiatsu treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive complementary therapy to alleviate symptoms and improve the quality of life for patients with cardiac amyloidosis.
How similar studies have performed: Previous studies have indicated that complementary therapies like Shiatsu can positively impact chronic illness symptoms, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Créteil
- Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR — Créteil, France (Recruiting)
Study contacts
- Study coordinator: JULIE POMPOUGNAC, Dr
- Email: julie.pompougnac@aphp.fr
- Phone: 00 33 6 35 37 61 63
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.