Impact of Tai Chi Therapy on Fatigue and Cognitive Function in Individuals With Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial.

Background: Chronic fatigue syndrome (CFS) is a psychosomatic disorder characterized by persistent fatigue, primarily involving physical and mental exhaustion, with greater emphasis on the latter. This leads to a deterioration in concentration and memory. These symptoms affect cognitive functions, including attention and memory, to varying degrees. Previous research has shown that Tai Chi can help reduce fatigue in individuals with CFS. However, the relationship between alleviating CFS-related fatigue through Tai Chi and its impact on cognitive functions remains unclear. The effects of Tai Chi on cognitive functions in individuals with CFS have not been clinically validated, and its efficacy and safety have yet to be examined through large-scale randomized controlled trials. Therefore, this protocol outlines a pilot randomized, parallel, single-blind clinical trial designed to evaluate the impact of Tai Chi therapy on fatigue and cognitive functions in individuals with CFS, using both subjective and objective assessments.

Objective: This pilot study aims to explore the preliminary efficacy and safety of Tai Chi in reducing fatigue and improving cognitive function in patients with CFS, and to generate data to inform future large-scale trials.

Methods: We will conduct a randomized, analyst-blinded, parallel-controlled trial with a 12-week intervention period and a 4-week follow-up. Enrolled patients will be randomly assigned to either the Tai Chi group (30 patients) or the health education group (30 patients). The Tai Chi group will receive the 24-style simplified Tai Chi intervention, while the control group will receive a health education intervention. Following the 12-week intervention, a 4-week follow-up will be conducted. The Tai Chi group will train 3 times per week, consisting of 2 in-person sessions at the Physical Education Center of Shanghai University of Traditional Chinese Medicine and 1 self-directed session guided online by an instructor. The primary outcome measure is the 20-item Multi-Dimensional Fatigue Inventory (MFI-20). The secondary outcome measures include the Montreal Cognitive Assessment (MoCA), Pittsburgh Sleep Quality Index (PSQI), Attention Network Test (ANT), working memory performance (N-Back task), 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). Participant recruitment began in April 2024. All interventions and concurrent data collection will be completed by October 2025, and the 4-week postintervention follow-up assessments will be finalized by the end of October 2025. Data management is still ongoing; therefore, data analysis has not yet been performed.

Conclusions: As a pilot trial, the findings of this study will provide preliminary clinical evidence on the role of Tai Chi in improving cognitive function in patients with CFS and will serve as a foundation for designing future large-scale trials.

Trial registration: China Clinical Trials Registry ChiCTR2400082268; https://tinyurl.com/2tkr7j7x.

International registered report identifier (irrid): DERR1-10.2196/65958.