NCT06197165 Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
| NCT ID | NCT06197165 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Cardiac Amyloidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2026-04-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2024-03-12 with a primary completion date of 2026-04-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06197165 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06197165 currently recruiting?
Yes, NCT06197165 is actively recruiting participants. Contact the research team at julie.pompougnac@aphp.fr for enrollment information.
Where is the NCT06197165 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT06197165 clinical trial?
NCT06197165 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 108 participants.