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

NCT06197165 | Recruiting DMC

• 1 other identifier: APHP230424
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Amyloidosis

Keywords

Cardiac amyloidosis - Targeted Shiatsu - pain

Outcome Measures

Primary Outcomes (1)

• 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).

  31 days ± 1 day

Secondary Outcomes (1)

• MEASUREMENT PHYSIO, SUDOSCAN, E-PATCH

  48 hours

Study Arms (2)

Shiatsu

EXPERIMENTAL

Comfort Shiatsu: 39 Targeted Shiatsu: 39

Other: Targeted Shiatsu

without Shiatsu

ACTIVE COMPARATOR

patients with cardiac amyloidosis with severe symptoms

Other: Targeted Shiatsu

Interventions

Targeted Shiatsu OTHER

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

Shiatsu; without Shiatsu

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• Known pregnancy or breast-feeding;
• Patient under AME.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, 94010, France

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Central Study Contacts

JULIE POMPOUGNAC, Dr

CONTACT

00 33 6 35 37 61 63; julie.pompougnac@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 9, 2024
• Study Start: March 12, 2024
• Primary Completion: April 12, 2026
• Study Completion: April 12, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)