Clinical data will be analyzed by independent statisticians who do not know the test procedure based on the principles of intention to treat (ITT) and per protocol. The statistical significance threshold has p value <0.05. The results of the participants who failed to complete the study will be considered no different from the baseline data in ITT analysis. All continuous variables will be presented as mean ± standard deviation. The categorical variables will be described in percentage (%). The clinical data in the two groups (FC group and HS group) will be compared with two-sample t-tests, and the comparisons of the baseline and after intervention in each group will be compared with a paired sample t-test. Nonparametric tests (Mann–Whitney U test) will be used to compare nonnormally distributed clinical data, and the χ2 test or Fisher's test will be used to compare categorical variables.

For fMRI scans, all preprocessing steps will be performed using DPABI software based on MATLAB. The main analytical methods include the amplitude of low-frequency fluctuation amplitude (ALFF) and seed-based functional connectivity.

After preprocessing the data, the ALFF will be calculated to compare the whole-brain spontaneous activity pattern before and after intervention in each group, as well as between patients with FC and HS following 10-week Tai Chi practices. The different regions obtained at ALFF analysis will be selected as the region of interest (ROI), also called seed, to perform the seed-based functional connectivity analysis and to explore the functional synchronization of ROI and other regions. The thresholds of p < 0.05 with a false discovery rate correlation will be applied to all analyses.

To investigate the associations between nonspecific effects and central responses under different physical conditions, we performed the correlation analysis between the clinical data, including motor function, respiratory function, psychological state, and cerebral function in patients with FC and HS. In order to further explain the regulation mechanism of Tai Chi on the brain-gut interaction disorder, the correlation analysis among gastrointestinal symptoms, heart rate variability, and brain function activities in FC patients will also be carried out.

Adverse events might happen during Tai Chi practice, including strain, sprain, nausea, and dizziness. If any these adverse events occur, the instructor will take appropriate treatment according to clinician's advice and record the processing detail in the CRFs. The safety assessments will be monitored by the Ethics Committee.

The schedule of the study, including enrollment, interventions, assessments, and visits for participants, is shown in Table 1.

Study period.

This is a neuroimaging trial that includes a 2-week baseline period and a 10-week treatment period. In the baseline period, recruited patients will be screened according to the inclusion criteria and exclusion criteria, and then, eligible FC patients and HS will sign an informed consent form and receive a physical examination. After allocation, the FC patients and HS will be recruited and will receive 10 weeks of Tai Chi exercise. Schedule of enrollment, interventions, and assessments: at the baseline, the median of intervention (5 weeks of exercise), and the end of the intervention (10 weeks of exercise). Among them, lower-extremity muscle strength was measured using a hand-held isometric dynamometer (Micro FET3; Hoggan Health Industries). Functional balance tests include BBS, TUG test, and functional reach test. During the vital capacity test, FEV1, FVC, and FEV1/FVC ratio were measured using a MicroMedical Super Spiro spirometer in resting status. PEFR was assayed using a peak flow meter. The stool diary, CCS, and PAC-SYM will be used to evaluate the clinical efficacy of different interventions; the PAC-QOL will be used to assess the health-related QOL; the SDS, SAS, EPQ, and Mini-Mental State Examinations will be used to consider the effect of psychological factors on the patients' symptoms. All participants will be assessed during the 24 h HRV to evaluate the autonomic nervous function at the baseline and the end of the 10-week intervention. fMRI scans will be performed to detect the cerebral functional changes in 15 patients in each group both at the baseline and the end of the intervention.

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