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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years ;

Transthyretin of genetic origin (TTR) ;

Transthyretin of non-mutated origin (WT) ;

Light Chain (AL);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Targeted Shiatsu

    Other intervention

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

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: ShiatsuExperimental treatment 1 intervention
Group B: without ShiatsuActive comparator 1 intervention

Trial outcomes

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).

Time frame
31 days ± 1 day

Secondary outcomes

1

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

Time frame
48 hours

Other outcomes

Sponsors and contacts

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