Study of Targeted Shiatsu Therapy on Symptoms and Quality of Life in Adults with Severe Cardiac Amyloidosis

What this Trial Is About

This research aims to evaluate the effects of targeted Shiatsu therapy on symptoms and quality of life in patients with severe cardiac amyloidosis. It compares three targeted Shiatsu sessions with comfort Shiatsu and no Shiatsu, focusing on short-term impacts on neuro-cardiovascular physiological parameters and symptoms such as fatigue, sleep issues, pain, anxiety, depression, breathing difficulties, digestive problems, and nausea. The study also assesses patient satisfaction and tolerance to Shiatsu treatment. The trial is a randomized, controlled, double-blind study conducted at a single center, involving 108 patients with different types of amyloidosis TTR, WT, AL. Participants are assigned to receive either targeted Shiatsu, comfort Shiatsu, or no Shiatsu. The study schedule includes an initial visit with questionnaires and physiological measurements, followed by Shiatsu sessions on days 7 and 14 for the Shiatsu groups, with multiple follow-up visits and telephone contacts to monitor symptoms and quality of life. Participants will complete various symptom and quality of life questionnaires and undergo physiological tests such as skin conductance SUDOSCAN and heart rate variability monitoring e-patch. Follow-up assessments occur at several timepoints up to one month after the third Shiatsu session. The primary outcome is the reduction in symptom scores 48 hours after the third Shiatsu session. Secondary outcomes include improvements in physiological measures and specific symptom scales. Safety and patient satisfaction are also evaluated throughout the study.

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