Self-administered Dual-task Training for Reducing Falls Among the Older Adults

NCT ID: NCT05533333

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Older Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Assessor-blinded, multi-centre parallel-group RCT with economic evaluation
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
A person not involved in the study (student helper #1) will randomise the participants using a random number list prepared by Dr Chen Huijun Cynthia (statistician) before the baseline assessment. One HK-registered physiotherapist (RA1) will be recruited to conduct workshops on teaching the exercise interventions to all participants. One research postgraduate (RPg) student will be recruited to conduct all of the other methodological procedures involved in the project. Assessments will be performed by an existing postgraduate student of the PI, who is blind to treatment condition. An economic evaluation with healthcare utility estimation will be performed by Dr Chen Huijun Cynthia. The treatment allocation coding will be unblinded following the completion of the study.

Study Groups

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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.

Group Type EXPERIMENTAL

Falls prevention exercises

Intervention Type BEHAVIORAL

A dual-task activity involves the simultaneous performance of two activities involving physical and cognitive tasks.

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.

Group Type ACTIVE_COMPARATOR

Falls prevention exercises

Intervention Type BEHAVIORAL

A dual-task activity involves the simultaneous performance of two activities involving physical and cognitive tasks.

Interventions

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Falls prevention exercises

A dual-task activity involves the simultaneous performance of two activities involving physical and cognitive tasks.

Intervention Type BEHAVIORAL

Other Intervention Names

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Balance exercises

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

National University of Singapore

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Stanley J Winser, PhD

Role: CONTACT

+85227666746 ext. 6746

Jobair MD Khan, MSCPT

Role: CONTACT

+85265805636 ext. 6747

Facility Contacts

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Stanley J Winser, PhD

Role: primary

27666746 ext. 6746

Jobair Md Khan, MScPT

Role: backup

+85265805636 ext. 6746

References

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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.

Reference Type DERIVED
PMID: 40555445 (View on PubMed)

Other Identifiers

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0034640

Identifier Type: -

Identifier Source: org_study_id

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