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FallNCT06563661

A Specific Dance Intervention in Older Adults in Hong Kong

A study testing The 21-style specific dance exercises in people with Fall and Age Problem, run by The Hong Kong Polytechnic University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a fully-powered randomised controlled trial and an essential follow-up study of our pilot work. The 21-style specific dance intervention to improve the balance and reduce the risks of falls (SDIIBRF) was suggested to be interesting, achievable, and compliable, according to the participants' feedback in… Read more about this study

Who is it for?
Ages 65 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Fall, Age Problem
What is being tested?
The 21-style specific dance exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Dec 2024to 31 May 2026
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 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • age 65 or above;
  • a total score of less than 25/28 in the Tinetti Performance Oriented Mobility Assessment (POMA) scale.

Who cannot join

  • a total score of less than 24/30 in the Chinese version of the Mini-Mental State Examination (MMSE-C);
  • the existence of any untreated cerebral vascular disease, Parkinson's disease, or any other major neurological deficit;
  • the existence of any medical condition that can affect their safety during dance training sessions;
  • unable to stand independently for at least 15 minutes without a walking aid;
  • unable to walk independently indoor for at least 20 metres without a walking aid;
  • previous experience of dance training;
  • currently participating in any other formal exercise programme.

Trial locations and contacts

1 site in 1 country.

Thomson Wong, PhD, BScPT contact

(852)27666717

thomson.wong@polyu.edu.hk

China1 site
  • Thomson Wong

    Hong Kong

    Thomson Wong, PhD, BScPT, (852)27666717, thomson.wong@polyu.edu.hk

Other trials in China

About this study

Official title: The Efficacy of a Specific Dance Intervention to Improve the Balance and Reduce the Risks of Falls (SDIIBRF) in Older Adults: A Randomised Controlled Trial

This study is a fully-powered randomised controlled trial and an essential follow-up study of our pilot work. The 21-style specific dance intervention to improve the balance and reduce the risks of falls (SDIIBRF) was suggested to be interesting, achievable, and compliable, according to the participants' feedback in the investigators' pilot work. Due to the expertly-designed and specifically-designed characteristics of the 21 dance styles in the SDIIBRF for improving balance and reducing risk of falls in older adults, the dance steps included in the SDIIBRF are unique and are largely different from the dance interventions that have already been reported in the literature. Based on the encouraging results of the preliminary efficacy in the investigators' pilot work and dance being a mind-body exercise, the investigators hypothesise that the specific dance programme will be efficacious in reducing the frequency of falls (primary outcome measure), improving the balance (secondary outcome measure for the main fall risk factor), and reducing the physical and psychological fall risk factors (secondary outcome measures) in Hong Kong's at-risk older adults. The findings could provide important new evidence for a feasible option for older adults as an innovative fall prevention exercise programme. The research question is "Can the 21-style SDIIBRF reduce the frequency of falls, improve the balance, and reduce the fall risks in Hong Kong's older adults at moderate to high risk of falling? Therefore, the aim of this proposed study is to examine the efficacy of the 21-style SDIIBRF in reducing the frequency of falls, improving the balance, and reducing the fall risks in Hong Kong's older adults by comparing it with a wait-list control.

Read the detailed description

One-hundred older adults will be recruited from different collaborating elderly community and rehabilitation centres in Hong Kong by convenience sampling. The participants (N=100) will be randomly assigned by an independent person using concealed block randomisation via a sealed and opaque envelope system to either the dance group (DANG; n=50) or the wait-list control group (WLCG; n=50). A computerised random-number generator will determine an allocation schedule. The older adults at moderate to high risk of falling living in Hong Kong, as indicated by a score of less than 25/28 in the Tinetti Performance Oriented Mobility Assessment (POMA) scale, will be randomly assigned to either the DANG or the wait-list control group (WLCG). The inclusion criteria will be (1) age 65 or above and (2) a total score of less than 25/28 in the POMA. The exclusion criteria will be (1) a total score of less than 24/30 in the Chinese version of the Mini-Mental State Examination (MMSE-C), (2) the existence of any untreated cerebral vascular disease, Parkinson's disease, or any other major neurological deficit, (3) the existence of any medical condition that can affect their safety during dance training sessions, (4) unable to stand independently for at least 15 minutes without a walking aid, (5) unable to walk independently indoor for at least 20 metres without a walking aid, (6) previous experience of dance training, and (7) currently participating in any other formal exercise programme.

The participants in DANG will participate in 12 dance training sessions (~120 minutes each with rest breaks) in one of the four groups of 12-13 participants once a week for 12 weeks. All training sessions will be conducted in Hong Kong by two experienced dance instructors under the supervision of a registered physiotherapist (e.g., principal applicant TWL Wong). Any adverse events will be tracked and reported. As an augmented safety measure for the dance training sessions in a group, we will ensure that the dance instructors are informed each participant's fall risk assessment so that close supervision of those with the highest fall risk can be guaranteed. The dance instructors will also gradually progress the balance challenge level as classes progress. The participants in the DANG will practise the 21-style specific dance exercises. The participants in the WLCG will be provided a fall prevention pamphlet with a set of conventional fall prevention exercises (e.g., including a set of balance, walking, and resistance exercises) at the start and will receive the training from the 21-style SDIIBRF after three scheduled assessment sessions with two waiting periods of 12 weeks and 3 months in between. The walking exercises will also include the balance training components (e.g., walking and turning around, sideways walking, heel walk, toe walk, and tandem walk). The participants in the WLCG will be asked to participate in 12 training sessions at home (~120 minutes each with rest breaks) once a week for 12 weeks. An exercise logbook will be provided to the participants in the WLCG to record their exercise compliance. If any of the participants is uncertain about the exercises, it is advised that the participant should contact the research staff immediately for further advice before the participant continues the exercises. The 21 dance styles (dance in a group), chosen and modified from seven dance styles, including cha-cha, jive, rumba, salsa, waltz, tango, and macarena, were developed by a group of experienced dance and rehabilitation experts and have been previously practised by a group of older adults in our pilot work, demonstrating good feasibility and positive participants' feedback. As a cautionary measure to maximize our participants' safety and restrict them from imprecisely practising the dance styles at home, all participants will be strongly advised not to practise without professional supervision. However, the participants will be encouraged to find the suitable opportunity to continue the dance activities under professional supervision after completion of the training sessions, so as to benefit from social interaction. For those older adults who can perform the dance styles excellently and stably under the assessment of the qualified dance instructors and practise at home becomes possible, additional safety advice will be provided, including the advice on appropriate warm up and cool down, sufficient and safe space, appropriate footwear, and dance at the appropriate level.

Both the DANG and WLCG will undertake three assessment sessions: before training at baseline (T0), just after the completion of the 12 dance training sessions (T1), and 3 months after the completion of the training sessions (T2) to examine the programme's efficacy. An independent assessor who is blinded to the participants' group allocation will perform the assessments. During T0, a questionnaire will be used to collect participants' demographic information, fall history (past 12 months and others by self-recall), medical history, current medications, and social history. The participants will be asked to prospectively record the number of falls they have experienced each day between T0, T1, and T2, using a structural calendar, and their frequency of falls (primary outcome measure) will be collected at T1 and T2. A fall will be counted if it will cause our participant(s) unintentionally coming to rest on the ground or other lower level. Afterwards, a series of assessments will be used to evaluate the participants' balance ability, through the Berg Balance Scale (BBS - secondary outcome measure for the main fall risk factor), and other physical and psychological fall risk factors (secondary outcome measures) at T0, T1, and T2. Since all eligible participants will be at moderate to high risk of falling, no ceiling effect of the BBS is anticipated; that is, all will begin treatment with relatively low scores. Additionally, the participants will be asked to record their ongoing compliance with dance and other physical activities during the follow-up period (from T1 to T2) using a daily diary. As an experienced registered physiotherapist in Hong Kong, the principal applicant TWL Wong will train all independent assessors and ensure that they perform the assessments accurately.

BBS will assess the balance ability (secondary outcome measure for the main fall risk factor) of the participants. BBS is a well-recognised and widely used functional balance assessment scale with good validity and reliability. The scale comprises 14 daily balance tasks in which participants have to maintain balance while completing them. The maximum total score is 56, and each of the 14 items could be scored between 0 and 4. Lower scores indicate poorer balance ability and a higher risk of falling (i.e., 0-20 = high risk; 21-40 = moderate risk; 41-56 = low risk). The BBS is a comprehensive tool to assess balance with the advantages of clinically relevant, standardised scoring, sensitive to change, and can assist in clinical decision-making and intervention planning. Concerning the other physical fall risk factors (secondary outcome measures), a functional gait and balance assessment will be conducted using the POMA and Timed Up and Go (TUG) tests. These two tests have been extensively used and widely recognised as clinical assessment tools for evaluating functional gait and balance with good validity and reliability. The POMA assesses the components of gait (12 points with seven items) and balance (16 points with nine items) with a total score of 28 points. A lower total score suggests a higher risk of falling (i.e., ≤18 = high risk; 19-24 = moderate risk; ≥25 = low risk). For example, the item 'Nudged' is useful in measuring the ability of an older adult to withstand a perturbation that could cause a fall. The TUG test has both discriminative and predictive properties related to older adult falls. The test requires participants to stand up from a chair, walk 3 metres, turn around, walk back 3 metres, turn around, and sit down on the chair at a comfortable pace. The total time taken to complete this task will be recorded. A longer completion time illustrates a higher risk of falling (e.g., taking more than 13.5 seconds to complete the TUG test indicates a high risk of falling in older community-dwelling adults). Flexibility will be measured via the "Chair Sit-and-Reach" (CSR) test. A shorter reaching distance represents poorer flexibility and a higher risk of falling. Muscle strength of the major lower limb muscles groups (e.g., knee and hip extensors) will be measured using the well-recognised Lafayette manual muscle testing system (e.g., Model 01163 or equivalent). A lower score represents poorer muscle strength and a higher risk of falling. Agility will be assessed by the 8 Foot Up-and-Go Test (8FUG). A longer completion time indicates poorer agility and a higher risk of falling.

In addition, various valid and reliable assessment tools will assess different psychological fall risk factors (secondary outcome measures). The Chinese version of the Falls Efficacy Scale International [FES-I (Ch)] will quantify the fear of falling. A higher score indicates a higher fear of falling, indicating a higher risk of falling. The Chinese version of the Activities-specific Balance Confidence Scale [ABC (Ch)] will examine the balance confidence. A lower score indicates poorer balance confidence and, thus, a higher risk of falling. Depression levels will be evaluated by the Chinese version of the four-item Geriatric Depression Scale (GDS-4C). GDS-4C was developed as a simple but valid and reliable alternative to the 15-item and 30-item versions of the GDS and displays good sensitivity (60-76%) and specificity (65-81%), using the cut-off point of 2 or more in older population. A higher score represents a higher depression level, suggesting a higher risk of falling. Anxiety levels will be evaluated by the Chinese version of the State-Trait Anxiety Inventory (STAT-SC \& STAI-TC). A higher score suggests a higher anxiety level and, thus, a higher risk of falling. The MMSE-C will only be used as a screening tool to inspect the preliminary cognitive function at T0. A structured questionnaire will be used to record participants' feedback. Participants' satisfaction will be measured by a Participant Satisfaction Questionnaire. The adherence of the participants in the dance programme will be assessed by recording the attendance to dance training sessions and compliance with the dance styles. The treatment fidelity will also be assessed by comparing all the dance training sessions with the established dance training protocol. Participants' ongoing compliance with dance and other physical activities from T1 to T2 will be recorded.

Conditions
Fall, Age Problem
Being tested
The 21-style specific dance exercises
Keywords
Efficacy, Dance programme, Falls prevention, Older adults, Balance, Risk of falling, Fall risk factors, Hong Kong SAR, Randomised controlled trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The 21-style specific dance exercisesOther

    The 21 dance styles (dance in a group), chosen and modified from seven dance styles, including cha-cha, jive, rumba, salsa, waltz, tango, and macarena, were developed by a group of experienced dance and rehabilitation experts and have been previously practised by a group of older adults in our pilot work, demonstrating good feasibility and positive participants' feedback.

Study groups in NCT06563661
Study groupRoleWhat they receive
Dance group (DANG)ExperimentalThe participants in DANG will participate in 12 dance training sessions with the 21-style specific dance exercises (~120 minutes each with rest breaks) in a group once a week for 12 weeks.
Receives: Other: The 21-style specific dance exercises
Wait-list control group (WLCG)Active comparatorThe participants in the WLCG will be provided a fall prevention pamphlet with a set of conventional fall prevention exercises (e.g., including a set of balance, walking, and resistance exercises) at the start and will receive the training from the 21-style specific dance exercises after three scheduled assessment sessions with two waiting periods of 12 weeks and 3 months in between.
Receives: Other: The 21-style specific dance exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline Frequency of Falls

    A fall will be counted if it will cause our participant(s) unintentionally coming to rest on the ground or other lower level.

    Measured: Day 0

  2. Changes from Baseline Frequency of Falls at 12 weeks

    A fall will be counted if it will cause our participant(s) unintentionally coming to rest on the ground or other lower level.

    Measured: Week 12

  3. Changes from Baseline Frequency of Falls at 24 weeks

    A fall will be counted if it will cause our participant(s) unintentionally coming to rest on the ground or other lower level.

    Measured: Week 24

Secondary outcomes (31)
  1. Baseline Balance Ability

    Berg Balance Scale (BBS) with scores range from 0 to 56. Higher scores represent better balance ability.

    Measured: Day 0

  2. Changes from Baseline Balance Ability at 12 weeks

    Berg Balance Scale (BBS) with scores range from 0 to 56. Higher scores represent better balance ability.

    Measured: Week 12

  3. Changes from Baseline Balance Ability at 24 weeks

    Berg Balance Scale (BBS) with scores range from 0 to 56. Higher scores represent better balance ability.

    Measured: Week 24

  4. Baseline Functional Gait and Balance Assessment

    The Tinetti Performance Oriented Mobility Assessment (POMA) with scores range from 0 to 28. Higher scores represent better functional gait and balance.

    Measured: Day 0

  5. Changes from Baseline Functional Gait and Balance Assessment at 12 weeks

    The Tinetti Performance Oriented Mobility Assessment (POMA) with scores range from 0 to 28. Higher scores represent better functional gait and balance.

    Measured: Week 12

  6. Changes from Baseline Functional Gait and Balance Assessment at 24 weeks

    The Tinetti Performance Oriented Mobility Assessment (POMA) with scores range from 0 to 28. Higher scores represent better functional gait and balance.

    Measured: Week 24

  7. Baseline Functional Gait Assessment

    Timed Up and Go (TUG) test

    Measured: Day 0

  8. Changes from Baseline Functional Gait Assessment at 12 weeks

    Timed Up and Go (TUG) test

    Measured: Week 12

  9. Changes from Baseline Functional Gait Assessment at 24 weeks

    Timed Up and Go (TUG) test

    Measured: Week 24

  10. Baseline Flexibility

    The Chair Sit-and-Reach test (CSR)

    Measured: Day 0

  11. Changes from Baseline Flexibility at 12 weeks

    The Chair Sit-and-Reach test (CSR)

    Measured: Week 12

  12. Changes from Baseline Flexibility at 24 weeks

    The Chair Sit-and-Reach test (CSR)

    Measured: Week 24

  13. Baseline Muscle Strength

    Muscle strength of the major lower limb muscles groups (e.g., knee and hip extensors) will be measured using the well-recognised Lafayette manual muscle testing system (e.g., Model 01163 or equivalent).

    Measured: Day 0

  14. Changes from Baseline Muscle Strength at 12 weeks

    Muscle strength of the major lower limb muscles groups (e.g., knee and hip extensors) will be measured using the well-recognised Lafayette manual muscle testing system (e.g., Model 01163 or equivalent).

    Measured: Week 12

  15. Changes from Baseline Muscle Strength at 24 weeks

    Muscle strength of the major lower limb muscles groups (e.g., knee and hip extensors) will be measured using the well-recognised Lafayette manual muscle testing system (e.g., Model 01163 or equivalent).

    Measured: Week 24

  16. Baseline Agility

    The 8 Foot Up-and-Go Test (8FUG)

    Measured: Day 0

  17. Changes from Baseline Agility at 12 weeks

    The 8 Foot Up-and-Go Test (8FUG)

    Measured: Week 12

  18. Changes from Baseline Agility at 24 weeks

    The 8 Foot Up-and-Go Test (8FUG)

    Measured: Week 24

  19. Preliminary Cognitive Function

    The Chinese version of the Mini-Mental State Examination (MMSE-C) with scores range from 0 to 30. Higher scores represent better cognitive function.

    Measured: Day 0

  20. Baseline Fear of Falling

    The Chinese version of the Falls Efficacy Scale International [FES-I (Ch)] with scores range from 16 to 64. Higher scores represent higher fear of falling.

    Measured: Day 0

  21. Changes from Baseline Fear of Falling at 12 weeks

    The Chinese version of the Falls Efficacy Scale International [FES-I (Ch)] with scores range from 16 to 64. Higher scores represent higher fear of falling.

    Measured: Week 12

  22. Changes from Baseline Fear of Falling at 24 weeks

    The Chinese version of the Falls Efficacy Scale International [FES-I (Ch)] with scores range from 16 to 64. Higher scores represent higher fear of falling.

    Measured: Week 24

  23. Baseline Balance Confidence

    The Activities-specific Balance Confidence Scale [ABC (Ch)] with scores range from 0 to 100. Higher scores represent higher balance confidence.

    Measured: Day 0

  24. Changes from Baseline Balance Confidence at 12 weeks

    The Activities-specific Balance Confidence Scale [ABC (Ch)] with scores range from 0 to 100. Higher scores represent higher balance confidence.

    Measured: Week 12

  25. Changes from Baseline Balance Confidence at 24 weeks

    The Activities-specific Balance Confidence Scale [ABC (Ch)] with scores range from 0 to 100. Higher scores represent higher balance confidence.

    Measured: Week 24

  26. Baseline Depression Levels

    The Chinese version of the four-item Geriatric Depression Scale (GDS-4C) with scores range from 0 to 4. Higher scores represent higher depression level.

    Measured: Day 0

  27. Changes from Baseline Depression Levels at 12 weeks

    The Chinese version of the four-item Geriatric Depression Scale (GDS-4C) with scores range from 0 to 4. Higher scores represent higher depression level.

    Measured: Week 12

  28. Changes from Baseline Depression Levels at 24 weeks

    The Chinese version of the four-item Geriatric Depression Scale (GDS-4C) with scores range from 0 to 4. Higher scores represent higher depression level.

    Measured: Week 24

  29. Baseline Anxiety Levels

    The Chinese version of the State-Trait Anxiety Inventory (STAT-SC \& STAI-TC) with scores range from 20 to 80. Higher scores represent higher anxiety level.

    Measured: Day 0

  30. Changes from Baseline Anxiety Levels at 12 weeks

    The Chinese version of the State-Trait Anxiety Inventory (STAT-SC \& STAI-TC) with scores range from 20 to 80. Higher scores represent higher anxiety level.

    Measured: Week 12

  31. Changes from Baseline Anxiety Levels at 24 weeks

    The Chinese version of the State-Trait Anxiety Inventory (STAT-SC \& STAI-TC) with scores range from 20 to 80. Higher scores represent higher anxiety level.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

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
A randomised, controlled (wait-list control), and two-armed trial.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06563661
Sponsor's protocol ID
21221561
Status last verified
Aug 2024
First submitted
16 Aug 2024
Last updated
23 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing The 21-style specific dance exercises in people with Fall and Age Problem, run by The Hong Kong Polytechnic University at 1 site in China.

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 2 inclusion and 7 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 23 Aug 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 China. 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 Thomson Wong, PhD, BScPT ((852)27666717, thomson.wong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Frequency of Falls (time frame: Day 0). The study lists 3 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 23 Aug 2024.

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