Online Group-based Dual-task Training to Improve Cognitive Function of Community-dwelling Older Adults

Aging Well Clinical Trial

Official title:

Online Group-based Dual-task Training to Improve Cognitive Function of Community-dwelling Older Adults: A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05573646
• Other study ID #: 19200991
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: The University of Hong Kong
• Contact: Pui Hing Chau, PhD
• Phone: 39176626
• Email: phpchau[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging Well

Intervention

Other:
• Dual-task training
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.
• Attention Control
Participants will receive eight one-hour online group-based interactive education on health topics other than exercise and cognitive health.

Locations

Country	Name	City	State
Hong Kong	Nursing Home	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Health and Medical Research Fund

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline subjective memory complaints at 6 weeks	Measured by Memory Inventory in Chinese. The sum of score ranges from 0 to 108, higher score indicates more memory complaints.	Six weeks after baseline
Primary	Change from baseline subjective memory complaints at 12 weeks	Measured by Memory Inventory in Chinese. The sum of score ranges from 0 to 108, higher score indicates more memory complaints.	12 weeks after baseline
Primary	Change from baseline subjective memory complaints at 18 weeks	Measured by Memory Inventory in Chinese. The sum of score ranges from 0 to 108, higher score indicates more memory complaints.	18 weeks after baseline
Secondary	Change from baseline cognitive status at 6 weeks	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.	Six weeks after baseline
Secondary	Change from baseline cognitive status at 12 weeks	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
Secondary	Change from baseline cognitive status at 18 weeks	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.	18 weeks after baseline
Secondary	Change from baseline working memory at 6 weeks	Measured by Digit Span Test. The longer the series, the better the condition.	Six weeks after baseline
Secondary	Change from baseline working memory at 12 weeks	Measured by Digit Span Test. The longer the series, the better the condition.	12 weeks after baseline
Secondary	Change from baseline working memory at 18 weeks	Measured by Digit Span Test. The longer the series, the better the condition.	18 weeks after baseline
Secondary	Change from baseline executive function at 6 weeks	Measured by Chinese version of the Victoria Stroop Test, with more time and errors as worse condition.	Six weeks after baseline
Secondary	Change from baseline executive function at 12 weeks	Measured by Chinese version of the Victoria Stroop Test, with more time and errors as worse condition.	12 weeks after baseline
Secondary	Change from baseline executive function at 18 weeks	Measured by Chinese version of the Victoria Stroop Test, with more time and errors as worse condition.	18 weeks after baseline
Secondary	Change from baseline lower-limb muscle strength at 6 weeks	Measured by the 5-times chair stand task. The longer the time participants use to finish the task, the poorer the performance.	Six weeks after baseline
Secondary	Change from baseline lower-limb muscle strength at 12 weeks	Measured by the 5-times chair stand task. The longer the time participants use to finish the task, the poorer the performance.	12 weeks after baseline
Secondary	Change from baseline lower-limb muscle strength at 18 weeks	Measured by the 5-times chair stand task. The longer the time participants use to finish the task, the poorer the performance.	18 weeks after baseline
Secondary	Change from baseline happiness at 6 weeks	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.	Six weeks after baseline
Secondary	Change from baseline happiness at 12 weeks	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.	12 weeks after baseline
Secondary	Change from baseline happiness at 18 weeks	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.	18 weeks after baseline
Secondary	Change from baseline depressive symptoms at 6 weeks	Measured by the Patient Health Questionnaire-9. The scale ranged from 0 to 27, higher score indicates higher level of depressive symptoms.	Six weeks after baseline
Secondary	Change from baseline depressive symptoms at 12 weeks	Measured by the Patient Health Questionnaire-9. The scale ranged from 0 to 27, higher score indicates higher level of depressive symptoms.	12 weeks after baseline
Secondary	Change from baseline depressive symptoms at 18 weeks	Measured by the Patient Health Questionnaire-9. The scale ranged from 0 to 27, higher score indicates higher level of depressive symptoms.	18 weeks after baseline
Secondary	Change from baseline social isolation/integration at 6 weeks	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.	Six weeks after baseline
Secondary	Change from baseline social isolation/integration at 12 weeks	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.	12 weeks after baseline
Secondary	Change from baseline social isolation/integration at 18 weeks	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.	18 weeks after baseline
Secondary	Change from baseline instrumental activity of daily living at 6 weeks	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.	Six weeks after baseline
Secondary	Change from baseline instrumental activity of daily living at 12 weeks	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.	12 weeks after baseline
Secondary	Change from baseline instrumental activity of daily living at 18 weeks	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.	18 weeks after baseline