NCT06197165Recruiting
Amylo-Shiatsu-Acute-Chronic: Effects of Shiatsu on Symptoms and Quality of Life of Amyloidosis Patients
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 26 Dec 2023
- Start date
- 12 Mar 2024
- Primary completion date
- 12 Apr 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Amyloidosis
- NCT number
- NCT06197165
What you commit to
- Study type: Interventional
- Planned participants: 108
- From 12 Mar 2024 to the primary completion date, 12 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have already received Shiatsu treatment;
- Participating in another interventional study, or within the exclusion period of a previous study, if applicable;
Other
- Patients with orthostatic hypotension;
- Patients with bullous amyloidosis (fragile skin);
- Patient with insufficient autonomy to maintain sitting position;
- Patient with insufficient autonomy to move from home to hospital;
- Known pregnancy or breast-feeding;
- Patient under known guardianship at the time of inclusion;
- Patient under AME.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique - Hopitaux de Paris - CHU Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.