- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05533333
Self-administered Dual-task Training for Reducing Falls Among the Older Adults (sDTT)
Cost-effectiveness of Self-administered Dual-task Training (sDTT) for Reducing Falls Among Older Adults: A Multi-centre-randomized Controlled Trial With Economic Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stanley J Winser, PhD
- Phone Number: 6746 +85227666746
- Email: stanley.j.winser@polyu.edu.hk
Study Contact Backup
- Name: Jobair MD Khan, MSCPT
- Phone Number: 6747 +85265805636
- Email: mdjobair.khan@connect.polyu.hk
Study Locations
-
-
Kowloon
-
Hung Hom, Kowloon, Hong Kong, 00
- Recruiting
- The Hong Kong Polytechnic University
-
Contact:
- Stanley J Winser, PhD
- Phone Number: 6746 27666746
- Email: stanley.j.winser@polyu.edu.hk
-
Contact:
- Jobair Md Khan, MScPT
- Phone Number: 6746 +85265805636
- Email: mdjobair.khan@connect.polyu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self administered dual-task training
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. |
A dual-task activity involves the simultaneous performance of two activities involving physical and cognitive tasks.
Other Names:
|
Active Comparator: Self-administered singletask training
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.
|
A dual-task activity involves the simultaneous performance of two activities involving physical and cognitive tasks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change score at week 12 and week 36
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dual-task cost of balance performance will be assessed for the TUG
Time Frame: Change score at week 12 and week 36
|
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.
|
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
|
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.
|
Change score at week 12 and week 36
|
Berg Balance Scale (BBS)
Time Frame: Change score at week 12 and week 36
|
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.
|
Change score at week 12 and week 36
|
Falls Efficacy Scale- International (FES-I)
Time Frame: Change score at week 12 and week 36
|
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
|
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
|
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
|
Change score at week 12 and week 36
|
Montreal Cognitive Assessment (MoCA)
Time Frame: Change score at week 12 and week 36
|
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.
|
Change score at week 12 and week 36
|
EuroQol 5 dimension 5 level EQ5D5L
Time Frame: Change score at week 12 and week 36
|
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.
|
Change score at week 12 and week 36
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0034640
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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