Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 30, 2024
Date Accepted: Mar 31, 2025
Impact of Tai Chi Therapy on Fatigue and Cognitive Function in Individuals with Chronic Fatigue Syndrome: A Research Protocol for a Pilot Randomized Controlled Trial
ABSTRACT
Background:
Chronic fatigue syndrome (CFS) is a psychosomatic disorder characterized by persistent fatigue, predominantly comprising physical and mental exhaustion, with significant emphasis on the latter, which causes concentration and memory deterioration. These characteristics affect cognitive functions including attention and memory at diverse extents. Previous research has shown that Tai Chi can inhibit fatigue in individuals with CFS. Nevertheless, the association between the alleviation of CFS-related fatigue and Tai Chi and its impact on cognitive functions remains unclear. The impact of Tai Chi on cognitive functions in CFS has not been validated clinically, and its efficacy and safety have not been examined via extensive randomized controlled trials. Consequently, this protocol study aimed to present a randomized, parallel, single-blind clinical trial that evaluates the impact of Tai Chi therapy on fatigue and cognitive functions in CFS via subjective and objective evaluations.
Objective:
The aim of this study was to evaluate the efficacy and safety of Tai Chi on fatigue and cognitive function in patients with CFS.
Methods:
We will conduct a randomized, analyst-blinded, parallel-controlled trial with a 12-week intervention and 4-week follow-up.The enrolled patients will be randomly divided into the Tai Chi group (28 patients) and the health education group (28 patients). The Tai Chi group will receive intervention with the 24-style simplified Tai Chi, while the control group will receive health education intervention. After continuous treatment for 12 weeks, a 4-week follow-up will be conducted. The Tai Chi group will receive training three times a week, with two offline classes at the Physical Education Center of Shanghai University of Traditional Chinese Medicine and one autonomous exercise (guided by the teacher online). The primary outcome indicator is the Multi-Dimensional Fatigue Scale (MFI-20), and the secondary outcome indicators are the Montreal Cognitive Assessment (MoCA), Pittsburgh Sleep Quality Index Scale (PSQI), Attention Network Test (ANT) working memory (N-back), and magnetic resonance imaging.
Results:
The research protocol and informed consent form were approved by the Shanghai Clinical Research Ethics Committee on March 18, 2024 (approval number: SECCR2024-22-01). Recruitment began in April 2024. The intervention plan was completed in October 2025, and data collection was completed by the end of December 2025.Data management is still in progress; therefore, data analysis has yet to be performed.
Conclusions:
This study will evaluate the efficacy and safety of Tai Chi in improving cognitive function in patients with chronic fatigue syndrome. If the results meet the expected outcomes, the findings of this study will provide clinical evidence for the treatment of cognitive function in patients with chronic fatigue syndrome. Clinical Trial: China Clinical Trials Registry ChiCTR2200061229;https://www.chictr.org.cn/showproj.html?proj=223860
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