An interventional study of Dual-task training in Community-dwelling Seniors, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Prevention
Objectives:
This study aims to explore the feasibility and acceptance of group-based dual-task training for prevention of cognitive decline in a pragmatic setting for community-dwelling older adults.
The primary objective is to assess recruitment rate, attendance rate, retention rate and satisfaction rate of participants.
Study design and participants:
This is a pilot pragmatic RCT with waitlist control. First, a co-design approach will be adopted to develop the intervention with the older adults. Then, about six participating community centres will nominate staff or volunteer to receive the training in order to lead the intervention. Informed consent will be sought from the participants and baseline assessment will be conducted. The participants will be randomly allocated to the intervention and control groups in 1:1 ratio using block randomisation with varying block size. At the end of the study, one representative of each participating centre will be invited to provide qualitative feedback.
Measurements:
The primary outcomes are the feasibility outcomes, namely the recruitment rate, attendance rate, the retention rate, and satisfaction rate of participants. Secondary outcomes include completion rate of the interventionist, time to recruit target sample size, factors influencing older adults' decision to participate and staff of the community centre to organise the activity, subjective memory complaints, working memory, executive function, and cognitive status of participants. A structured questionnaire will be used to collect quantitative outcomes related to effects and satisfaction. Qualitative feedback from representatives of the elderly community centres will be collected according to a semi-structured interview guide.
Expected results: The intervention is feasible and highly accepted by the participants and staff of the community centres. Potential effect-related outcomes are to be demonstrated.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 93 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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(i) aged 65 years and above,
(ii) eligible to enrol in activities organised by the community centres,
(iii) no communication problems,
(iv) able to understand and follow instructions,
(v) able to read and write Chinese.
Exclusion Criteria:
contraindications to chair-based or stepping exercises.
The intervention group will start 6 week dual-task invention immediately after baseline.
Other: Dual-task training
The control group will start 6 week dual-task invention after the follow-up assessment 6 weeks after baseline.
Other: Dual-task training
Participants will receive a one-hour face-to-face group-based dual-task training session twice a week for 6 weeks. Training included cognitive components and physical components to be conducted simultaneously.
Recruitment rate
Recruitment rate is defined as the number of participants agreed to join the study before randomization divided by the number of potential participants who completed recruitment briefing.
Time frame: After baseline, before randomization
Attendance rate
Attendance rate is defined as the number of attended intervention sessions collected in attendance log divided by the number of planned intervention sessions.
Time frame: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.
Retention rate
Retention rate is defined as the number of participants completing the post-intervention assessment divided by the number of participants at baseline.
Time frame: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.
Satisfaction rate
Satisfaction to the project will be measured by a question using 5-point Likert scale (very satisfactory to very unsatisfactory). Satisfaction rate is defined as the number of participants rating the intervention a score of ≥4 out of 5 divided by the number of participants started intervention.
Time frame: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.
Completion rate of the interventionist
The number of nominated staff/volunteers considered as completing the project divided by the total number of nominated staff/volunteers
Time frame: End of study, up to 2 years
Time to recruit target sample size
The time needed to recruit target sample size is defined as the time taken to recruit required sample size in each centre.
Time frame: Before baseline
Factors influencing older adults' decision to participate and staff of the community centre to organise the activity
Reasons of the older adults and staff of the community centres for joining or not joining the study
Time frame: At the end of recruitment briefing, before baseline
Change from baseline subjective memory complaints at 6 weeks
Subjective memory complaints will be measured by the 27-item Memory Inventory in Chinese (Lui et al., 2006). Participants response on the frequency of complaints related to daily living in the past month, using 0 (none) to 4 (continuously). The scale ranges from 0 to 108, higher score indicates more memory complaints.
Time frame: 6 weeks after baseline
Change from baseline subjective memory complaints at 12 weeks
Subjective memory complaints will be measured by the 27-item Memory Inventory in Chinese (Lui et al., 2006). Participants response on the frequency of complaints related to daily living in the past month, using 0 (none) to 4 (continuously). The scale ranges from 0 to 108, higher score indicates more memory complaints.
Time frame: 12 weeks after baseline, only for waitlist control group
Change from baseline working memory at 6 weeks
Working memory will be measured by Digit Span Test (Leung et al., 2011). The participants will repeat the digits series which are gradually longer. In both the forward and the backward test, the longer the series, the better the condition.
Time frame: 6 weeks after baseline
Change from baseline working memory at 12 weeks
Working memory will be measured by Digit Span Test (Leung et al., 2011). The participants will repeat the digits series which are gradually longer. In both the forward and the backward test, the longer the series, the better the condition.
Time frame: 12 weeks after baseline, only for waitlist control group
Change from baseline executive function at 6 weeks
Executive function will be measured by Chinese version of the Victoria Stroop Test (Lee and Chan, 2000). The completion time and number of errors that the participants made in naming the colour in the presence of different stimuli (number dots, words unrelated to color, words related to color) will be recorded, with more time and errors as worse condition.
Time frame: 6 weeks after baseline
Change from baseline executive function at 12 weeks
Executive function will be measured by Chinese version of the Victoria Stroop Test (Lee and Chan, 2000). The completion time and number of errors that the participants made in naming the colour in the presence of different stimuli (number dots, words unrelated to color, words related to color) will be recorded, with more time and errors as worse condition.
Time frame: 12 weeks after baseline, only for waitlist control group
Change from baseline cognitive status at 6 weeks
Cognitive status will be measured by the Montreal Cognitive Assessment 5-Minutes (Hong Kong Version) (HK-MoCA 5-Min) protocol. The validated assessment test covers four domains: attention, executive functions/language, orientation, and memory (Yeung et al., 2014). The total score ranges from 0 to 30; a higher score indicates better cognitive status.
Time frame: 6 weeks after baseline
Change from baseline cognitive status at 12 weeks
Cognitive status will be measured by the Montreal Cognitive Assessment 5-Minutes (Hong Kong Version) (HK-MoCA 5-Min) protocol. The validated assessment test covers four domains: attention, executive functions/language, orientation, and memory (Yeung et al., 2014). The total score ranges from 0 to 30; a higher score indicates better cognitive status.
Time frame: 12 weeks after baseline, only for waitlist control group
Qualitative feedback
Qualitative feedback on facilitators and barriers of organising the activity will be collected from one representative of each participating centre by semi-structured interview.
Time frame: At the end of the study, up to 2 years
Plan to share: No
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