Older AdultssDTTNCT05533333
Self-administered Dual-task Training for Reducing Falls Among the Older Adults
A study testing Falls prevention exercises in people with Older Adults, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Evidence supports that dual-task training reduces fall risk among older adults. However, the current framework for preventive care for fall prevention in Hong Kong does not include formal cognitive training, while little to no emphasis is placed on combining physical and cognitive training (dual tasking) to prevent… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Falls prevention exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Community-dwelling
- Ambulant with or without the use of a walking assistive device
- Have experienced at least one fall over the past 6 months and
- Obtained a mini-mental state examination score of ≥ 24 (indicating the absence of cognitive impairment).
Who cannot join
- Have been diagnosed with dementia or Alzheimer's disease,
- Have a previous history of psychiatric illness
- Are only able to walk with hand-held support
- Have a severe visual impairment that prevents exercise participation.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hung Hom, Kowloon, 00
Stanley J Winser, PhD, 27666746 ext. 6746, stanley.j.winser@polyu.edu.hk
Jobair Md Khan, MScPT, +85265805636 ext. 6746, mdjobair.khan@connect.polyu.hk
About this study
Official title: Cost-effectiveness of Self-administered Dual-task Training (sDTT) for Reducing Falls Among Older Adults: A Multi-centre-randomized Controlled Trial With Economic Evaluation
Evidence supports that dual-task training reduces fall risk among older adults. However, the current framework for preventive care for fall prevention in Hong Kong does not include formal cognitive training, while little to no emphasis is placed on combining physical and cognitive training (dual tasking) to prevent falls. Secondly, the healthcare costs for eligible Hong Kong citizens are subsidised by between 81 and 97% of the actual treatment cost. Therefore, there is a demanding need for cost-effective treatment to reduce the country's' economic burden. This project will assist policymakers and clinicians in recommending cost-effective treatments for fall prevention.
Read the detailed description
Objective: Evaluate the effectiveness and cost-effectiveness of self-administered dual-task training (sDTT) for preventing falls among older adults and promote this technique to the target population and healthcare workers of Hong Kong.
Design: In Phase 1, a multi-centre randomised controlled trial (RCT) with economic evaluation will evaluate the effectiveness and cost-effectiveness. In Phase 2, the technique will be promoted through hands-on workshops for older adults and helpers; and promotional talks with physiotherapists and rehabilitation nurses.
Setting: Community-based elderly care centres. Participants: For the RCT, we will recruit 190 community-dwelling older (≥65 years) adults of both genders having experienced at least one fall in the past 6 months. 500 community-dwelling older adults will be recruited for the workshop and 100 healthcare workers will be engaged for promotion activities.
Intervention: In Phase 1, the experimental group will receive sDTT from a physiotherapist once every 2 weeks for 12 weeks. They will perform home exercises once per week for 12 weeks. Unsupervised exercises will then continue over the next 6 months. Control group will receive the same amount of self-administered single-task training as the experimental group.
Primary outcome measure: Number of falls will be assessed at baseline (T1), post-intervention after 12 weeks (T2) and 6 months (T3). Health promotion will be assessed using a knowledge and attitude questionnaire.
Analysis: General linear mixed model with maximum likelihood estimation will compare primary and secondary outcome measures. Cost-effectiveness will be assessed from the Hong Kong healthcare perspective. Wilcoxon Signed-Rank test will assess the benefits of health promotion.
- Conditions
- Older Adults
- Being tested
- Falls prevention exercises
- Keywords
- Falls, Older adults, Dual-task, Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Falls prevention exercisesBehavioural
Also called Balance exercises
A dual-task activity involves the simultaneous performance of two activities involving physical and cognitive tasks.
| Study group | Role | What they receive |
|---|---|---|
| Self administered dual-task training | Experimental | The exercise intervention will continue for 9 months, beginning with 12 weeks of training accompanied by workshops to teach the exercises.
Experimental group: sDTT group participants will be instructed to perform 10 minutes of warm-up, 40 minutes of dual-task training and 10 minutes of cool-down exercises. The size of the workshop will be limited to 10 participants. The sDTT programme includes performing a selection of six cognitive tasks during walking, the sit-to-stand movement, heel and toe raising, stepping, tandem standing and walking and multidirectional reaching tasks. The cognitive tasks will include mental tracking, working memory, auditory cues and verbal fluency tasks. Participants will be given the freedom to mix and match the physical and cognitive tasks to make them more challenging. Receives: Behavioral: Falls prevention exercises |
| Self-administered singletask training | Active comparator | Control group: The self-administered single-task training group will receive 10 minutes of warm-up, 20 minutes of physical tasks (as outlined above) and 20 minutes of cognitive tasks (as outlined above) followed by 10 minutes of cool-down exercises. Participants will be instructed to perform the exercises for the same dosage as the experimental group. After a 6-month follow-up period, the control group will receive two complimentary sessions of self-administered dual-task training. Receives: Behavioral: Falls prevention exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of falls
The number of falls will be recorded from the baseline using each participant's digital diary interface. Participants will be instructed to record the number of falls on a weekly basis. The baseline assessment of falls will be calculated as the number of falls over the past 3 months from the day of study enrolment
Measured: Change score at week 12 and week 36
Secondary outcomes (7)
Dual-task cost of balance performance will be assessed for the TUG
Based on the scores of the standard TUG (single task), d-TUG (dual-task TUG) test and standard counting backwards, the dual-task cost of balance performance will be estimated using the formula: (d-TUG - Standard TUG)/ Standard-TUG) × 100.
Measured: Change score at week 12 and week 36
Dual-task cost of cognitive performance will be assessed for the TUG
Based on the scores of the standard TUG (single task), d-TUG (dual-task TUG) test and standard counting backwards, the dual-task cost of balance performance will be estimated using the formula: (d-TUG - Standard counting backwards)/ Standard counting backwards) × 100.
Measured: Change score at week 12 and week 36
Berg Balance Scale (BBS)
The functional balance will be assessed using the 14 item Berg Balance Scale. The Berg Balance Scale has a minimum score of 0 and a maximum of 56 with higher the score better the balance.
Measured: Change score at week 12 and week 36
Falls Efficacy Scale- International (FES-I)
The fear of falls will be assessed using the Falls Efficacy Scale- International (FES-I). This self-reported scale requires the user to rate 16 items between 1 and 4 where 1 implies no difficulty and 4 indicates maximum difficulty. The scale is scored from 16 to 64 with higher the scores indicating higher concerns of falling
Measured: Change score at week 12 and week 36
12-item Short Form Health Survey (SF-12)
The quality of life will be assessed using the 12-item Short Form Health Survey (SF-12) questionnaire. This self-reported questionnaire requires users to complete 12 questions that covers eight domains relevant to general measure of health. An online calculator will be used to derive the final score
Measured: Change score at week 12 and week 36
Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA) estimates memory, executive function, attention, language, abstraction, naming, delayed recall and orientation. This brief tool scores cognitive function out of 30, with a higher score equating to better function.
Measured: Change score at week 12 and week 36
EuroQol 5 dimension 5 level EQ5D5L
Health status will be assessed using the EuroQol-5-dimension-5-level (EQ-5D-5L). It is a standardised measure of health status used for economic appraisal. The Chinese translated version of the EQ 5D 5L will be used.
Measured: Change score at week 12 and week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Dec 2022
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assessor-blinded, multi-centre parallel-group RCT with economic evaluation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, National University of Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533333
- Sponsor's protocol ID
- 0034640
- Acronym
- sDTT
- Status last verified
- Nov 2023
- First submitted
- 5 Sep 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khan MJ, Fong KNK, Wong TW, Tsang WW, Chen CH, Chan WC, Winser S. Self-administered dual-task training reduces balance deficits and falls among community-dwelling older adults: a multicentre parallel-group randomised controlled trial with economic evaluation protocol. BMJ Open. 2025 Jun 24;15(6):e089915. doi: 10.1136/bmjopen-2024-089915.
PubMed 40555445
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Self-administered Dual-task Training (sDTT) for Reducing Falls Among Older Adults: A Multi-centre-randomized Controlled Trial With Economic Evaluation
- ClinicalTrials.gov ID
- NCT05533333
- Acronym / sponsor ID
- sDTT / 0034640
- Conditions
- Older Adults
- Keywords
- Falls, Older adults, Dual-task, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong, National University of Singapore
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Sep 2022 (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.
Evidence supports that dual-task training reduces fall risk among older adults. However, the current framework for preventive care for fall prevention in Hong Kong does not include formal cognitive training, while little to no emphasis is placed on combining physical and cognitive training (dual tasking) to prevent falls. Secondly, the healthcare costs for eligible Hong Kong citizens are subsidised by between 81 and 97% of the actual treatment cost. Therefore, there is a demanding need for cost-effective treatment to reduce the country's' economic burden. This project will assist policymakers and clinicians in recommending cost-effective treatments for fall prevention.
Detailed description
Objective: Evaluate the effectiveness and cost-effectiveness of self-administered dual-task training (sDTT) for preventing falls among older adults and promote this technique to the target population and healthcare workers of Hong Kong.
Design: In Phase 1, a multi-centre randomised controlled trial (RCT) with economic evaluation will evaluate the effectiveness and cost-effectiveness. In Phase 2, the technique will be promoted through hands-on workshops for older adults and helpers; and promotional talks with physiotherapists and rehabilitation nurses.
Setting: Community-based elderly care centres. Participants: For the RCT, we will recruit 190 community-dwelling older (≥65 years) adults of both genders having experienced at least one fall in the past 6 months. 500 community-dwelling older adults will be recruited for the workshop and 100 healthcare workers will be engaged for promotion activities.
Intervention: In Phase 1, the experimental group will receive sDTT from a physiotherapist once every 2 weeks for 12 weeks. They will perform home exercises once per week for 12 weeks. Unsupervised exercises will then continue over the next 6 months. Control group will receive the same amount of self-administered single-task training as the experimental group.
Primary outcome measure: Number of falls will be assessed at baseline (T1), post-intervention after 12 weeks (T2) and 6 months (T3). Health promotion will be assessed using a knowledge and attitude questionnaire.
Analysis: General linear mixed model with maximum likelihood estimation will compare primary and secondary outcome measures. Cost-effectiveness will be assessed from the Hong Kong healthcare perspective. Wilcoxon Signed-Rank test will assess the benefits of health promotion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Assessor-blinded, multi-centre parallel-group RCT with economic evaluation
| Arm | Type | Receives |
|---|---|---|
| Self administered dual-task training | Experimental | Behavioral: Falls prevention exercisesThe exercise intervention will continue for 9 months, beginning with 12 weeks of training accompanied by workshops to teach the exercises. Experimental group: sDTT group participants will be instructed to perform 10 minutes of warm-up, 40 minutes of dual-task training and 10 minutes of cool-down exercises. The size of the workshop will be limited to 10 participants. The sDTT programme includes performing a selection of six cognitive tasks during walking, the sit-to-stand movement, heel and toe raising, stepping, tandem standing and walking and multidirectional reaching tasks. The cognitive tasks will include mental tracking, working memory, auditory cues and verbal fluency tasks. Participants will be given the freedom to mix and match the physical and cognitive tasks to make them more challenging. |
| Self-administered singletask training | Active comparator | Behavioral: Falls prevention exercisesControl group: The self-administered single-task training group will receive 10 minutes of warm-up, 20 minutes of physical tasks (as outlined above) and 20 minutes of cognitive tasks (as outlined above) followed by 10 minutes of cool-down exercises. Participants will be instructed to perform the exercises for the same dosage as the experimental group. After a 6-month follow-up period, the control group will receive two complimentary sessions of self-administered dual-task training. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Community-dwelling
- Ambulant with or without the use of a walking assistive device
- Have experienced at least one fall over the past 6 months and
- Obtained a mini-mental state examination score of ≥ 24 (indicating the absence of cognitive impairment).
Key exclusion criteria (4 listed)
- Have been diagnosed with dementia or Alzheimer's disease,
- Have a previous history of psychiatric illness
- Are only able to walk with hand-held support
- Have a severe visual impairment that prevents exercise participation.
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 |
|---|---|---|
| Falls prevention exercisesAlso: Balance exercisesA dual-task activity involves the simultaneous performance of two activities involving physical and cognitive tasks. | Behavioural | Self administered dual-task training, Self-administered singletask training |
Primary outcome
Number of falls
Time frame: Change score at week 12 and week 36
The number of falls will be recorded from the baseline using each participant's digital diary interface. Participants will be instructed to record the number of falls on a weekly basis. The baseline assessment of falls will be calculated as the number of falls over the past 3 months from the day of study enrolment
7 secondary outcomes
Dual-task cost of balance performance will be assessed for the TUG
Time frame: Change score at week 12 and week 36
Dual-task cost of cognitive performance will be assessed for the TUG
Time frame: Change score at week 12 and week 36
Berg Balance Scale (BBS)
Time frame: Change score at week 12 and week 36
Falls Efficacy Scale- International (FES-I)
Time frame: Change score at week 12 and week 36
12-item Short Form Health Survey (SF-12)
Time frame: Change score at week 12 and week 36
Montreal Cognitive Assessment (MoCA)
Time frame: Change score at week 12 and week 36
EuroQol 5 dimension 5 level EQ5D5L
Time frame: Change score at week 12 and week 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 40555445Khan MJ, Fong KNK, Wong TW, Tsang WW, Chen CH, Chan WC, Winser S. Self-administered dual-task training reduces balance deficits and falls among community-dwelling older adults: a multicentre parallel-group randomised controlled trial with economic evaluation protocol. BMJ Open. 2025 Jun 24;15(6):e089915. doi: 10.1136/bmjopen-2024-089915.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Falls prevention exercises in people with Older Adults, run by The Hong Kong Polytechnic University 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stanley J Winser, PhD (+85227666746 ext. 6746, stanley.j.winser@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of falls (time frame: Change score at week 12 and week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05533333, which also lists 1 linked publication.
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 15 Mar 2024.