The Specific and Nonspecific Effects of Tai Chi and Its Possible Central Responses: A Protocol of Neuroimaging Study

Table 1

Study period.

	Study period
	Enrollment	Allocation	Postallocation
Timepoint	−14 days	−7 days	0 day (baseline)	35 days (middle of intervention)	70 days (after intervention)	Etc.
Enrollment
Eligibility screen	✗
Informed consent	✗
Demographics	✗
Diagnosis	✗
Past medical history	✗
Physical examination		✗
Allocation		✗
Interventions
Group A (FC patients)			✗	✗	✗
Group B (HS)			✗	✗	✗
Assessments
BMI		✗			✗
HRV		✗			✗
Lower-extremity muscle			✗	✗	✗
Functional balance			✗	✗	✗
Vital capacity			✗	✗	✗
Exercise self-rating scale			✗	✗	✗
CCS			✗	✗	✗
PAC-QOL			✗	✗	✗
PAC-SYM			✗	✗	✗
Stool diary			✗	✗	✗
SDS, SAS			✗	✗	✗
EPQ			✗	✗	✗
SF-36			✗	✗	✗
MRI			✗		✗
Safety observation
Blood routine test			✗
Urine routine test			✗
Stool routine test			✗
Adverse events					✗

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.