- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05573646
Online Group-based Dual-task Training to Improve Cognitive Function of Community-dwelling Older Adults
Online Group-based Dual-task Training to Improve Cognitive Function of Community-dwelling Older Adults: A Feasibility Study
Objectives: This study aims to explore the feasibility, acceptance, and efficacy of online group-based dual-task training as an intervention for improving cognitive function among community-dwelling older adults.
Hypothesis to be tested: We hypothesize that after the intervention, there will be an improvement in the participants' cognitive function as compared with pre-intervention status and with the control group. Also, lower-limb muscle strength and psychosocial wellbeing will be improved after the intervention.
Design and subjects: This is a randomised controlled feasibility study. The target population is community-dwelling older adults with access to an online meeting platform. About 75 participants will be recruited and randomised to the intervention and attention control groups in a ratio of 2:1. Intervention group will receive 60 minutes of online group-based dual-task training twice a week for 12 weeks led by a trained facilitator. Cognitive training components include arithmetic operation, verbal fluency, and upper limb/finger movement. Physical training components are chair-based exercises. The training components will be selected using a co-design approach.
Instruments: Memory Inventory in Chinese (MIC), Digit Span Test, Victoria Stroop Test, Montreal Cognitive Assessment 5-Minutes (Hong Kong Version).
Main outcome measures: Subjective memory complaints as measured by MIC.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- Nursing home
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 65 years and above,
- no communication problems,
- able to communicate in Chinese, and
- able to use an online meeting platform.
Exclusion Criteria:
- contraindications to chair-based exercises, and
- engagement in any kind of cognitive training three months prior to the study or during the study period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Dual-task training
Dual-task training group
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Participants will receive a one-hour online group-based dual-task training session twice a week for 12 weeks, giving a total intervention time of 24 hours.
A co-design approach will be adopted to develop the training components in the dual-tasks.
For the cognitive training component, arithmetic operation, verbal fluency, and upper limb/ finger movements are included.
For the physical training component, we select chair-based exercises are included.
A group-based training mode led by a facilitator will be adopted.
During the session, participants will be asked to turn on their camera so that they can see and interact with each other.
They will also have their audio on as they will have to participate in the cognitive tasks by voicing out their answers.
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Other: Attention control
Attention control group
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Participants will receive eight one-hour online group-based interactive education on health topics other than exercise and cognitive health.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline subjective memory complaints at 6 weeks
Time Frame: Six weeks after baseline
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Measured by Memory Inventory in Chinese.
The sum of score ranges from 0 to 108, higher score indicates more memory complaints.
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Six weeks after baseline
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Change from baseline subjective memory complaints at 12 weeks
Time Frame: 12 weeks after baseline
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Measured by Memory Inventory in Chinese.
The sum of score ranges from 0 to 108, higher score indicates more memory complaints.
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12 weeks after baseline
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Change from baseline subjective memory complaints at 18 weeks
Time Frame: 18 weeks after baseline
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Measured by Memory Inventory in Chinese.
The sum of score ranges from 0 to 108, higher score indicates more memory complaints.
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18 weeks after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline cognitive status at 6 weeks
Time Frame: Six weeks after baseline
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Measured by the Montreal Cognitive Assessment 5-Minutes (Hong Kong Version) (HK-MoCA 5-Min) protocol.
The total score ranges from 0 to 30; a higher score indicates better cognitive status.
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Six weeks after baseline
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Change from baseline cognitive status at 12 weeks
Time Frame: 12 weeks after baseline
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Measured by the Montreal Cognitive Assessment 5-Minutes (Hong Kong Version) (HK-MoCA 5-Min) protocol.
The total score ranges from 0 to 30; a higher score indicates better cognitive status.
|
12 weeks after baseline
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Change from baseline cognitive status at 18 weeks
Time Frame: 18 weeks after baseline
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Measured by the Montreal Cognitive Assessment 5-Minutes (Hong Kong Version) (HK-MoCA 5-Min) protocol.
The total score ranges from 0 to 30; a higher score indicates better cognitive status.
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18 weeks after baseline
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Change from baseline working memory at 6 weeks
Time Frame: Six weeks after baseline
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Measured by Digit Span Test.
The longer the series, the better the condition.
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Six weeks after baseline
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Change from baseline working memory at 12 weeks
Time Frame: 12 weeks after baseline
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Measured by Digit Span Test.
The longer the series, the better the condition.
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12 weeks after baseline
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Change from baseline working memory at 18 weeks
Time Frame: 18 weeks after baseline
|
Measured by Digit Span Test.
The longer the series, the better the condition.
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18 weeks after baseline
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Change from baseline executive function at 6 weeks
Time Frame: Six weeks after baseline
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Measured by Chinese version of the Victoria Stroop Test, with more time and errors as worse condition.
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Six weeks after baseline
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Change from baseline executive function at 12 weeks
Time Frame: 12 weeks after baseline
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Measured by Chinese version of the Victoria Stroop Test, with more time and errors as worse condition.
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12 weeks after baseline
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Change from baseline executive function at 18 weeks
Time Frame: 18 weeks after baseline
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Measured by Chinese version of the Victoria Stroop Test, with more time and errors as worse condition.
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18 weeks after baseline
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Change from baseline lower-limb muscle strength at 6 weeks
Time Frame: Six weeks after baseline
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Measured by the 5-times chair stand task.
The longer the time participants use to finish the task, the poorer the performance.
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Six weeks after baseline
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Change from baseline lower-limb muscle strength at 12 weeks
Time Frame: 12 weeks after baseline
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Measured by the 5-times chair stand task.
The longer the time participants use to finish the task, the poorer the performance.
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12 weeks after baseline
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Change from baseline lower-limb muscle strength at 18 weeks
Time Frame: 18 weeks after baseline
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Measured by the 5-times chair stand task.
The longer the time participants use to finish the task, the poorer the performance.
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18 weeks after baseline
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Change from baseline happiness at 6 weeks
Time Frame: Six weeks after baseline
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Measured by the Chinese version of the 4-item Subjective Happiness Scale.
The score is the average of the four items, and ranges from 1 to 7; a higher score indicates a higher happiness level.
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Six weeks after baseline
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Change from baseline happiness at 12 weeks
Time Frame: 12 weeks after baseline
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Measured by the Chinese version of the 4-item Subjective Happiness Scale.
The score is the average of the four items, and ranges from 1 to 7; a higher score indicates a higher happiness level.
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12 weeks after baseline
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Change from baseline happiness at 18 weeks
Time Frame: 18 weeks after baseline
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Measured by the Chinese version of the 4-item Subjective Happiness Scale.
The score is the average of the four items, and ranges from 1 to 7; a higher score indicates a higher happiness level.
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18 weeks after baseline
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Change from baseline depressive symptoms at 6 weeks
Time Frame: Six weeks after baseline
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Measured by the Patient Health Questionnaire-9.
The scale ranged from 0 to 27, higher score indicates higher level of depressive symptoms.
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Six weeks after baseline
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Change from baseline depressive symptoms at 12 weeks
Time Frame: 12 weeks after baseline
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Measured by the Patient Health Questionnaire-9.
The scale ranged from 0 to 27, higher score indicates higher level of depressive symptoms.
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12 weeks after baseline
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Change from baseline depressive symptoms at 18 weeks
Time Frame: 18 weeks after baseline
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Measured by the Patient Health Questionnaire-9.
The scale ranged from 0 to 27, higher score indicates higher level of depressive symptoms.
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18 weeks after baseline
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Change from baseline social isolation/integration at 6 weeks
Time Frame: Six weeks after baseline
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Measured by the Chinese version of the 6-item Lubben Social Network Scale.
The total score ranges from 0 to 30; a higher score indicates a better social network.
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Six weeks after baseline
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Change from baseline social isolation/integration at 12 weeks
Time Frame: 12 weeks after baseline
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Measured by the Chinese version of the 6-item Lubben Social Network Scale.
The total score ranges from 0 to 30; a higher score indicates a better social network.
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12 weeks after baseline
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Change from baseline social isolation/integration at 18 weeks
Time Frame: 18 weeks after baseline
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Measured by the Chinese version of the 6-item Lubben Social Network Scale.
The total score ranges from 0 to 30; a higher score indicates a better social network.
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18 weeks after baseline
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Change from baseline instrumental activity of daily living at 6 weeks
Time Frame: Six weeks after baseline
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Measured by Lawton's eight selected tasks.
A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
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Six weeks after baseline
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Change from baseline instrumental activity of daily living at 12 weeks
Time Frame: 12 weeks after baseline
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Measured by Lawton's eight selected tasks.
A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
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12 weeks after baseline
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Change from baseline instrumental activity of daily living at 18 weeks
Time Frame: 18 weeks after baseline
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Measured by Lawton's eight selected tasks.
A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
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18 weeks after baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pui Hing Chau, PhD, School of Nursing, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19200991
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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