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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
RECRUITING
Créteil
Contact Information
Primary
JULIE POMPOUGNAC, Dr
julie.pompougnac@aphp.fr
00 33 6 35 37 61 63
Time Frame
Start Date: 2024-03-12
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 108
Treatments
Experimental: Shiatsu
Comfort Shiatsu: 39~Targeted Shiatsu: 39
Active_comparator: without Shiatsu
patients with cardiac amyloidosis with severe symptoms
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov