Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 4, 2023
Open Peer Review Period: Oct 4, 2023 - Nov 29, 2023
Date Accepted: Dec 28, 2023
(closed for review but you can still tweet)
Effects of the Prolong Life with Nine Turn-Method Qigong on Fatigue, Insomnia, Anxiety, and Gastrointestinal Disorders in Patients with chronic fatigue syndrome A Study Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Chronic Fatigue Syndrome (CFS) is a debilitating multi-system disorder that can lead to a variety of pathophysiological abnormalities. Prolong Life with Nine Turn Method (PLWNT) Qigong practice can alleviate the clinical symptoms of CFS and have a significant inhibitory effect.
Objective:
The aim of this study was to evaluate the efficacy and safety of PLWNT in terms of fatigue, insomnia, and gastrointestinal symptoms in CFS patients.
Methods:
We designed a randomized, analyst blind, parallel controlled trial for 208 patients. The patients will randomly divided into PLWNT group and the control group treated with cognitive behavioral therapy (CBT group). The primary outcome is Multi-dimensional Fatigue Inventory 20 (MFI-20). Secondary outcomes include Pittsburgh sleep quality index (PSQI), Gastrointestinal Symptom Rating Scale (GSRS), Hospital Anxiety and Depression Scale (HADS), fMRI, gut microbiota and peripheral blood. These will be assessed at week 0, 4, 8 and 12.
Results:
The protocol was approved in March 2022 by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese medicine (Ethics Approval Number 2022SHL-KY-05). Recruitment commenced in July 2022. Recruitment ended on December 31, 2024. Over the 3 years recruitment period, a total of 208 participants will recruited.
Conclusions:
We expect this randomized trial to evaluate the effectiveness of PLWNT in relieving fatigue, insomnia, anxiety, and gastrointestinal symptoms in patients with CFS. If it proves to be effective, it will help provide a promising alternative intervention for populations with CFS. Clinical Trial: The study was registered in the China Clinical Trials Registry (ChiCTR2200061229). The findings will be disseminated in peer-reviewed publications.
Citation
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