An interventional study of Health Education and Conventional Exercise in Mild Cognitive Impairment, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 315 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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:
A 26 weeks brain health and general health education program with two 1.5-hour sessions weekly.
Behavioral: Health Education
A 26 weeks Conventional Exercise training with two 1.5-hour sessions weekly.
Behavioral: Conventional Exercise
A 26 weeks Tai Chi training with two 1.5-hour sessions weekly.
Behavioral: Tai Chi
A 26 weeks brain health and general health education program with two 1.5-hour sessions weekly.
A 26 weeks Conventional Exercise training with two 1.5-hour sessions weekly.
A 26 weeks Tai Chi training with two 1.5-hour sessions weekly.
The score of the Montreal Cognitive Assessment (MoCA)
Change in the score of the Montreal Cognitive Assessment. The score ranged from 0 to 30. Higher score indicates a better cognitive function. Participants scoring equal or below the 7th percentile of the age- and education-corrected normative data will be considered as having MCI.
Time frame: 26 weeks
The score of the Montreal Cognitive Assessment (MoCA)
Change in the score of the Montreal Cognitive Assessment. The score ranged from 0 to 30. Higher score indicates a better cognitive function. Participants scoring equal or below the 7th percentile of the age- and education-corrected normative data will be considered as having MCI.
Time frame: 52 weeks
Clinical Dementia Rating
The Clinical Dementia Rating (CDR) is a numeric scale of 0-3 points based on clinician/ certified rater ratings of cognition and daily function in the domains of memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Rating from 0, 0.5, 1, 2 and 3 indicated subjects' cognitive function having healthy, very mild impairment, mild impairment, moderate impairment and severe impairment respectively.
Time frame: 26 weeks and 52 weeks
Neurocognitive Test
The NIH Toolbox Cognitive Function Battery (CFB) will be used to objectively evaluate the various cognitive domains. CFB assesses cognitive abilities in different cognitive domains, including memory, executive function and attention. CFB will be delivered on a tablet computer.
Time frame: 26 weeks and 52 weeks
Subjective Cognitive Performance
The Cognitive Self-Report Questionnaire (CSRQ) will be used to examine the subjective cognitive performance. The CSRQ is validated in Hong Kong and comprises 25 questions with an overall score ranging from 0-100. A higher score indicates worse self-perception on cognitive performance.
Time frame: 26 weeks and 52 weeks
Subjective Memory complaints
The memory inventory for the Chinese - a questionnaire exploring subjective memory complaints and the effects on daily activities - will be performed to examine the subjective memory complaints.
Time frame: 26 weeks and 52 weeks
Subjective Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quantity and the perceived restfulness and disturbance of sleep by gathering information on usual bed time, wake time, time to fall asleep, time of actual sleep, and quality of sleep. Each item is rated on a "0-3" Likert scale, with a higher score indicating poorer sleep quality.
Time frame: 26 weeks and 52 weeks
The Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale assesses the severity of depression and anxiety. This 14-item questionnaire has subscales for both depression and anxiety and the overall score ranges from 0-21, with a higher score indicating more severe depressive/anxious symptoms.
Time frame: 26 weeks and 52 weeks
The 12-Item Short Form Survey
The 12-Item Short Form Survey measures health-related quality of life. It has 12 items assessing physical functioning, emotional and mental health, bodily pain, general health, vitality, and social functioning, with higher overall scores indicating a better quality of life.
Time frame: 26 weeks and 52 weeks
Medication Use
Subjects' use of medications, unrelated to dementia and psychiatric conditions (e.g., sleep, dyslipidemic and hypertensive pills) will be recorded along with detailed usage information. Data on medication dose and weekly frequency will be presented as the total number of lowest recommended dose in 7 days for the analysis.
Time frame: 26 weeks and 52 weeks
Short Physical Performance Battery (SPPB) Test
Physical function and balancing performance will be assessed using the Short Physical Performance Battery (SPPB). The SPPB involves repeated timed chair stands, timed standing balance (with feet in parallel in semi-tandem and tandem positions), and a 4-meter walk to measure the usual gait speed.
Time frame: 26 weeks and 52 weeks
Habitual Physical Activity
Actigraph/IPAQ method to monitor and record habitual physical activity. Actigraph activity monitor (wGT3X-BT or GT9X, Actigraph, USA), a 3-axis accelerometer, will be used to objectively determine the habitual daily physical movement/activities.
Time frame: 26 weeks and 52 weeks
Plan to share: No
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The University of Hong Kong