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Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic RCT

Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic Randomised Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06648707
Enrollment
93
Registered
2024-10-18
Start date
2024-10-21
Completion date
2026-12-31
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-dwelling Seniors

Keywords

dual-task, cognitive training, Older adults, train-the-trainer

Brief summary

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.

Interventions

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.

Sponsors

Health and Medical Research Fund
CollaboratorOTHER_GOV
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

(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.

Design outcomes

Primary

MeasureTime frameDescription
Recruitment rateAfter baseline, before randomizationRecruitment 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.
Attendance rate6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.Attendance rate is defined as the number of attended intervention sessions collected in attendance log divided by the number of planned intervention sessions.
Retention rate6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.Retention rate is defined as the number of participants completing the post-intervention assessment divided by the number of participants at baseline.
Satisfaction rate6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.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.

Secondary

MeasureTime frameDescription
Change from baseline subjective memory complaints at 12 weeks12 weeks after baseline, only for waitlist control groupSubjective 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.
Change from baseline working memory at 6 weeks6 weeks after baselineWorking 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.
Change from baseline working memory at 12 weeks12 weeks after baseline, only for waitlist control groupWorking 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.
Change from baseline executive function at 6 weeks6 weeks after baselineExecutive 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.
Completion rate of the interventionistEnd of study, up to 2 yearsThe number of nominated staff/volunteers considered as completing the project divided by the total number of nominated staff/volunteers
Change from baseline cognitive status at 6 weeks6 weeks after baselineCognitive 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.
Change from baseline cognitive status at 12 weeks12 weeks after baseline, only for waitlist control groupCognitive 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.
Qualitative feedbackAt the end of the study, up to 2 yearsQualitative feedback on facilitators and barriers of organising the activity will be collected from one representative of each participating centre by semi-structured interview.
Change from baseline executive function at 12 weeks12 weeks after baseline, only for waitlist control groupExecutive 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 to recruit target sample sizeBefore baselineThe time needed to recruit target sample size is defined as the time taken to recruit required sample size in each centre.
Factors influencing older adults' decision to participate and staff of the community centre to organise the activityAt the end of recruitment briefing, before baselineReasons of the older adults and staff of the community centres for joining or not joining the study
Change from baseline subjective memory complaints at 6 weeks6 weeks after baselineSubjective 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.

Countries

Hong Kong

Contacts

Primary ContactPui Hing Chau, PhD
phpchau@hku.hk3917 6626

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026