Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06197165
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-26
Brief Title:
AMYLO-SHIATSU-ACUTE-CHRONIC
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
AMYLO-SHIATSU-ACUTE-CHRONIC EFFECTS OF SHIATSU ON SYMPTOMS AND QUALITY OF LIFE OF AMYLOIDOSIS PATIENTS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMYLO-SHIATSU
Brief Summary:
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
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 HypothesisObjective 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 45 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 patients dominant symptom 3 on the EESE-R ie 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 D71 day Group without Shiatsu nothing Shiatsu group patient will receive a 2nd Shiatsu session given by a Shiatsu specialist D71 day and will complete the modified TAQ questionnaire 48 hours after the session D91 day Visit 4 D141 day At D141 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 D161 day the patients 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 himher MINNESOTA EESE-R EQ-5D QCD BFI LSEQ HADS modified TAQ if applicable Telephone contact 2 D31 1 day At D311 day the patients 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
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 45 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 patients dominant symptom 3 on the EESE-R ie 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 D71 day Group without Shiatsu nothing Shiatsu group patient will receive a 2nd Shiatsu session given by a Shiatsu specialist D71 day and will complete the modified TAQ questionnaire 48 hours after the session D91 day Visit 4 D141 day At D141 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 D161 day the patients 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 himher MINNESOTA EESE-R EQ-5D QCD BFI LSEQ HADS modified TAQ if applicable Telephone contact 2 D31 1 day At D311 day the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None