Clinical trial NCT05540613: Tai Chi Versus Conventional Exercise to Improve Cognitive Performance in Older Adults With Mild Cognitive Impairment
Official title: Tai Chi Versus Conventional Exercise to Improve Cognitive Performance in Older Adults With Mild Cognitive Impairment (MCI): A Comparative Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 315
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to evaluate the effectiveness of Tai Chi and conventional exercise on improving cognitive function in older adults with mild cognitive impairment (MCI). Participants will be randomized into three six-month programmes, namely Health Education group, Tai Chi group and Conventional Exercise group. Assessments will be conducted at baseline, after the 26-week interventions, and 26-week after the competition of the intervention.


Eligibility criteria: Inclusion Criteria:

* Chinese older adults aged equal or larger than 50 years
* Ethnic Chinese
* MCI under criteria of Mayo Clinic, including the following

  i. people with subjective complaint about a decline in cognitive function. ii. total score in the Montreal Cognitive Assessment is equal or below the 7th percentile of the age- and education- corrected normative data of Hong Kong. iii. the decline in cognitive function does not impair daily functioning, as revealed by getting ≥2 marks in every item on the Chinese Lawton Instrumental Activities of Daily Living 4-point Scale).

Exclusion Criteria:

* medical history of major chronic diseases such as cancer, stroke, cerebro- and cardio-vascular diseases, and renal disease
* uncontrolled diabetes
* diagnosed with dementia or using anti-dementia medication
* diagnosed with psychiatric diseases or using psychiatric medication
* with diseases or on medications known to severely affect cognitive performance
* somatic condition (e.g., limb lost) that prevent participation in exercise
* impaired mobility by chronic diseases (e.g., neurological, musculoskeletal and autoimmune diseases)
* incapable to perform physical exercise
* regular exercise habit (\>3 times 60-min Tai Chi or moderate-intensity conventional exercise weekly) in the past 3 months

Primary outcomes:
measure: The score of the Montreal Cognitive Assessment (MoCA)
timeFrame: 26 weeks
measure: The score of the Montreal Cognitive Assessment (MoCA)
timeFrame: 52 weeks
Secondary outcomes:
measure: Clinical Dementia Rating
timeFrame: 26 weeks and 52 weeks
measure: Neurocognitive Test
timeFrame: 26 weeks and 52 weeks
measure: Subjective Cognitive Performance
timeFrame: 26 weeks and 52 weeks
measure: Subjective Memory complaints
timeFrame: 26 weeks and 52 weeks
measure: Subjective Sleep Quality
timeFrame: 26 weeks and 52 weeks
measure: The Hospital Anxiety and Depression Scale
timeFrame: 26 weeks and 52 weeks
measure: The 12-Item Short Form Survey
timeFrame: 26 weeks and 52 weeks
measure: Medication Use
timeFrame: 26 weeks and 52 weeks
measure: Short Physical Performance Battery (SPPB) Test
timeFrame: 26 weeks and 52 weeks
measure: Habitual Physical Activity
timeFrame: 26 weeks and 52 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Parco Siu, PhD
role: PRINCIPAL_INVESTIGATOR
References: