Factors contributing to cognitive improvement effects of acupuncture in patients with mild cognitive impairment: a pilot randomized controlled trial

Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement. The table shows the enrollment, interventions, and data collection protocols

	Study period
	Enrolment	Allocation	Post-allocation								Close-out
Timepoint	Screening		Visit1–3	Visit4–6	Visit7–9	Visit10–12	Visit13–15	Visit16–18	Visit19–21	Visit22–24	Visit25
Timepoint	Week		1	2	3	4	5	6	7	8	20
Enrolment
Informed consent	X
Sociodemographic profile	X
Medical history	X
Vital signs	X	X	X	X	X	X	X	X	X	X	X
Inclusion/exclusion criteria	X
Allocation		X
K-MMSE, MoCA-K	X
Interventions
Acupuncture treatment			X	X	X	X	X	X	X	X
Assessments
Change of medical history			X	X	X	X	X	X	X	X	X
Safety assessment			X	X	X	X	X	X	X	X	X
ADAS-K-cog			X							X	X
MoCA-K			X							X	X
CES-D			X							X	X
K-ADL, K-IADL			X							X	X
EQ-5D-5L			X							X	X

K-MMSE, Korean version of Mini-Mental State Examination; MoCA-K, Korean version of the Montreal Cognitive Assessment; ADAS-K-cog, Korean version of Alzheimer’s Disease Assessment Scale-cognitive subscale; CES-D, Center for Epidemiological Studies-Depression Scale; K-ADL, Korean Activities of Daily Living; K-IADL, Korean Instrumental Activities of Daily Living; EQ-5D-5L, European Quality of Life Five Dimension-Five Level Scale

ISSN: 1745-6215