AMYLO-SHIATSU-ACUTE-CHRONIC (AMYLO-SHIATSU)

AMYLO-SHIATSU-ACUTE-CHRONIC : EFFECTS OF SHIATSU ON SYMPTOMS AND QUALITY OF LIFE OF AMYLOIDOSIS PATIENTS

Demonstrate the beneficial impact of three targeted Shiatsu sessions versus "comfort" Shiatsu on symptoms in cardiac amyloidosis patients with severe symptoms. To demonstrate the beneficial short-term impact of a targeted SHIATSU session on neuro-cardio-vascular physiological parameters and symptoms in patients with cardiac amyloidosis compared with comfort Shiatsu and no Shiatsu. To demonstrate the beneficial impact of three targeted Shiatsu sessions versus "comfort" Shiatsu and no Shiatsu on symptoms (fatigue, sleep, pain, anxiety, depression dyspnea, digestive disorders, nausea) and quality of life in cardiac amyloidosis patients with severe symptoms. Evaluate patient satisfaction with shiatsu. Assess tolerance to shiatsu.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Amyloidosis
• Intervention / Treatment: Other: Targeted Shiatsu

Detailed Description

Intro: Amyloidosis leads to a wide range of disorders: vascular, cardiac, neuropathic, digestive, renal and others. These impairments are a source of disability, altered autonomy and quality of life, as well as stress and anxiety. The literature review demonstrates the positive impact of complementary approaches on these multiple symptoms of disabling chronic illnesses, as well as the efficacy of Shiatsu, attested by Evidence Based Medicine in a number of international studies. As part of a project to improve patient care and take better account of their needs and persistent, chronic symptoms, we thought of integrating Shiatsu targeted at amyloidosis symptoms as a complementary therapy. How can Shiatsu help patients with amyloidosis? What effect does Shiatsu have on amyloidosis patients' quality of life and their various symptoms? Hypothesis/Objective: Demonstrate the beneficial impact of three targeted Shiatsu sessions versus "comfort" Shiatsu on symptoms in cardiac amyloidosis patients with severe symptoms. To demonstrate the beneficial short-term impact of a targeted SHIATSU session on neuro-cardio-vascular physiological parameters and symptoms in patients with cardiac amyloidosis compared with comfort Shiatsu and no Shiatsu. To demonstrate the beneficial impact of three targeted Shiatsu sessions versus "comfort" Shiatsu and no Shiatsu on symptoms (fatigue, sleep, pain, anxiety, depression dyspnea, digestive disorders, nausea) and quality of life in cardiac amyloidosis patients with severe symptoms. Evaluate patient satisfaction with shiatsu. Assess tolerance to shiatsu.

Method: Randomized, controlled, superiority, single-center, double-blind study comparing the effects of "targeted" Shiatsu sessions on amyloidosis symptoms with the effects of "comfort" (non-targeted) Shiatsu sessions. Population: patients with amyloidosis (TTR, WT, AL) hospitalized or followed at the Centre de référence Amyloses-Cardiaques (Cardiogen branch) at the CHU Henri Mondor in Créteil, France. 108 patients in total: Shiatsu group (78 patients, 26 AL, 26 TTR, 26 WT), Comfort Shiatsu (39), Targeted Shiatsu (39), No Shiatsu group (30). Comparison group: Comfort Shiatsu group. Expected number of inclusions per center per month: 4.5, duration: 2 years. Primary endpoint: Reduction in total ESAS symptom score at 48 hours after third shiatsu session. Secondary endpoints: 20% improvement in heart rate variability measured with the e-patch; 20% improvement in skin conductance and variability measured with the SUDOSCAN. Overall score on the EQ-5D scale; Overall score on the MINNESOTA scale; Improvement of the questionnaire score corresponding to the symptom targeted by the Shiatsu session by 2 points (patient's dominant symptom ≥ 3 on the EESE-R), i.e. : on the Minnesota for the dominant symptom dyspnea; on the EESE-R for the dominant digestive symptoms "Digestive disorders"; on the QCD for the dominant symptom pain; Improvement of at least one global score on the BFI, HADS or LSEQ scales.

Inclusion visit (D0) The study will be offered to patients undergoing consultation as part of their routine care. At D0: Once consent has been signed, the patient will complete the questionnaires (MINNESOTA, EESE-R, EQ-5D, QCD, BFI, LSEQ, HADS). Measurement with the SUDOSCAN will be performed. The e-patch will be performed continuously for 48 hours. For patients in the Shiatsu group, the EESE-R questionnaire will be sent to the CRU for randomization. This will be carried out by an open-label CRA independent of the study. The results of the randomization are forwarded to the Shiatsu specialists of the group in which the patient is included (targeted or comfort). The CRA from the clinical research team at the Centre welcomes the patient and refers him or her to the shiatsu specialist who has been instructed to give either comfort shiatsu or shiatsu targeting a dominant symptom, depending on the outcome of the randomization. The patient will receive a Shiatsu session (Shiatsu group) according to his group (targeted Shiatsu or comfort Shiatsu). Research follow-up visits Visit 1 (D1) and Visit 2 (D2). At D1 in hospital, a second measurement with the SUDOSCAN will be taken at 24 hours from the Shiatsu session or from inclusion (group without Shiatsu), 2 measurements at 24H and 48H. On D2, a third measurement with the SUDOSCAN will be taken 48 hours after the Shiatsu session or inclusion (non-Shiatsu group). The patient will complete the following questionnaires: EESE-R and modified TAQ (if applicable). Visit 3 (D7±1 day). Group without Shiatsu: nothing. Shiatsu group: patient will receive a 2nd Shiatsu session given by a Shiatsu specialist (D7±1 day) and will complete the modified TAQ questionnaire 48 hours after the session (D9±1 day). Visit 4 (D14±1 day): At D14±1 day, the patient will receive a 3rd Shiatsu session given by a Shiatsu specialist (D14 ±1 day) and will complete the modified TAQ questionnaire 48 hours after the session (D16 ±1 day). Telephone visits Telephone contact 1 (D16 ±1 day). At D16±1 day, the patient's first telephone follow-up at 48 hours after the Shiatsu session will be carried out (TEC, ARC) in order to complete the following questionnaires with him/her: MINNESOTA, EESE-R, EQ-5D, QCD, BFI, LSEQ, HADS, modified TAQ (if applicable). Telephone contact 2 (D31 ±1 day). At D31±1 day, the patient's second telephone follow-up will be carried out by TEC or ARC in order to complete the following questionnaires with the patient: MINNESOTA, EESE-R, EQ-5D, QCD, BFI, LSEQ, HADS.

Conclusion: The expected benefits for patients are: An improvement in quality of life and symptoms (appetite, nausea, digestive disorders, sleep, fatigue, anxiety-depression, pain) and balancing of the ANS autonomic nervous system, weakened by the progression of pathologies and hospitalization.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JULIE POMPOUGNAC, Dr; Phone Number: 00 33 6 35 37 61 63; Email: julie.pompougnac@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shiatsu; Comfort Shiatsu: 39 Targeted Shiatsu: 39	Other: Targeted Shiatsu; demonstrate the beneficial impact targeted Shiatsu compared with a "comfort" Shiatsu
Active Comparator: without Shiatsu; patients with cardiac amyloidosis with severe symptoms	Other: Targeted Shiatsu; demonstrate the beneficial impact targeted Shiatsu compared with a "comfort" Shiatsu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MEASUREMENT PHYSIO, SUDOSCAN, E-PATCH	Description of secondary endpoint: 20% improvement in heart rate variability measured with the e-patch. Continuous measurement [0-48H] after first Shiatsu session	48 hours

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Association Française Contre l'Amylose (association of patients and families of patients)

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: December 26, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac amyloidosis - Targeted Shiatsu - pain
• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: APHP230424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No