Community-dwelling SeniorsNCT06648707
Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic RCT
A study testing Dual-task training in people with Community-dwelling Seniors, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community-dwelling Seniors
- What is being tested?
- Dual-task training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged 65 years and above,
- eligible to enrol in activities organised by the community centres,
- no communication problems,
- able to understand and follow instructions,
- able to read and write Chinese.
Who cannot join
- contraindications to chair-based or stepping exercises.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Community centre
Hong Kong
Pui Hing Chau, 3917 6626, phpchau@hku.hk
About this study
Official title: Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic Randomised Controlled Trial
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.
Read more
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.
- Conditions
- Community-dwelling Seniors
- Being tested
- Dual-task training
- Keywords
- dual-task, cognitive training, Older adults, train-the-trainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Assigned intervention | Other | The intervention group will start 6 week dual-task invention immediately after baseline. Receives: Other: Dual-task training |
| Assigned waitlist control | Other | The control group will start 6 week dual-task invention after the follow-up assessment 6 weeks after baseline. Receives: Other: Dual-task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.
Secondary outcomes (12)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of the study, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start21 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-dwelling SeniorsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Principal investigator, Dr. Pui-Hing Chau, The University of Hong Kong
- Investigators
- Pui Hing Chau, PhD, Principal investigator, School of Nursing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648707
- Sponsor's protocol ID
- UW 23-575
- Status last verified
- Dec 2024
- First submitted
- 11 Oct 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06648707
- Acronym / sponsor ID
- UW 23-575
- Conditions
- Community-dwelling Seniors
- Keywords
- dual-task, cognitive training, Older adults, train-the-trainer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assigned intervention | Other | Other: Dual-task trainingThe intervention group will start 6 week dual-task invention immediately after baseline. |
| Assigned waitlist control | Other | Other: Dual-task trainingThe control group will start 6 week dual-task invention after the follow-up assessment 6 weeks after baseline. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- aged 65 years and above,
- eligible to enrol in activities organised by the community centres,
- no communication problems,
- able to understand and follow instructions,
- able to read and write Chinese.
Key exclusion criteria (1 listed)
- contraindications to chair-based or stepping exercises.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-task trainingParticipants 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. | Other | Assigned intervention, Assigned waitlist control |
Primary outcome
Recruitment rate
Time frame: After baseline, before randomization
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.
Attendance rate
Time frame: 6 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 rate
Time frame: 6 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 rate
Time frame: 6 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.
12 secondary outcomes
Completion rate of the interventionist
Time frame: End of study, up to 2 years
Time to recruit target sample size
Time frame: Before baseline
Factors influencing older adults' decision to participate and staff of the community centre to organise the activity
Time frame: At the end of recruitment briefing, before baseline
Change from baseline subjective memory complaints at 6 weeks
Time frame: 6 weeks after baseline
Change from baseline subjective memory complaints at 12 weeks
Time frame: 12 weeks after baseline, only for waitlist control group
Change from baseline working memory at 6 weeks
Time frame: 6 weeks after baseline
Change from baseline working memory at 12 weeks
Time frame: 12 weeks after baseline, only for waitlist control group
Change from baseline executive function at 6 weeks
Time frame: 6 weeks after baseline
Change from baseline executive function at 12 weeks
Time frame: 12 weeks after baseline, only for waitlist control group
Change from baseline cognitive status at 6 weeks
Time frame: 6 weeks after baseline
Change from baseline cognitive status at 12 weeks
Time frame: 12 weeks after baseline, only for waitlist control group
Qualitative feedback
Time frame: At the end of the study, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pui Hing Chau, PhD principal investigator
School of Nursing, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-task training in people with Community-dwelling Seniors, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pui Hing Chau, PhD (3917 6626, phpchau@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: After baseline, before randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.