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.
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.
China1 site
Thomson Wong
Hong Kong
Thomson Wong, PhD, BScPT, (852)27666717, thomson.wong@polyu.edu.hk
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 group | Role | What they receive |
|---|---|---|
| Dance group (DANG) | Experimental | The 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 comparator | 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 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.
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
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
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)
Baseline Balance Ability
Berg Balance Scale (BBS) with scores range from 0 to 56. Higher scores represent better balance ability.
Measured: Day 0
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
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
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
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
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
Baseline Functional Gait Assessment
Timed Up and Go (TUG) test
Measured: Day 0
Changes from Baseline Functional Gait Assessment at 12 weeks
Timed Up and Go (TUG) test
Measured: Week 12
Changes from Baseline Functional Gait Assessment at 24 weeks
Timed Up and Go (TUG) test
Measured: Week 24
Baseline Flexibility
The Chair Sit-and-Reach test (CSR)
Measured: Day 0
Changes from Baseline Flexibility at 12 weeks
The Chair Sit-and-Reach test (CSR)
Measured: Week 12
Changes from Baseline Flexibility at 24 weeks
The Chair Sit-and-Reach test (CSR)
Measured: Week 24
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
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
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
Baseline Agility
The 8 Foot Up-and-Go Test (8FUG)
Measured: Day 0
Changes from Baseline Agility at 12 weeks
The 8 Foot Up-and-Go Test (8FUG)
Measured: Week 12
Changes from Baseline Agility at 24 weeks
The 8 Foot Up-and-Go Test (8FUG)
Measured: Week 24
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted21 Aug 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- 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)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, Education University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Thomson Wong, PhD, BScPT, Principal investigator, The Hong Kong Polytechnic University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06563661
- Acronym / sponsor ID
- 21221561
- Conditions
- Fall, Age Problem
- Keywords
- Efficacy, Dance programme, Falls prevention, Older adults, Balance, Risk of falling, Fall risk factors, Hong Kong SAR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong, Education University of Hong Kong
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 21 Aug 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised, controlled (wait-list control), and two-armed trial.
| Arm | Type | Receives |
|---|---|---|
| Dance group (DANG) | Experimental | Other: The 21-style specific dance exercisesThe 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. |
| Wait-list control group (WLCG) | Active comparator | Other: The 21-style specific dance exercisesThe 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. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age 65 or above;
- a total score of less than 25/28 in the Tinetti Performance Oriented Mobility Assessment (POMA) scale.
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| The 21-style specific dance exercisesThe 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. | Other | Dance group (DANG), Wait-list control group (WLCG) |
Primary outcome
Baseline Frequency of Falls
Time frame: Day 0
A fall will be counted if it will cause our participant(s) unintentionally coming to rest on the ground or other lower level.
Changes from Baseline Frequency of Falls at 12 weeks
Time frame: Week 12
A fall will be counted if it will cause our participant(s) unintentionally coming to rest on the ground or other lower level.
Changes from Baseline Frequency of Falls at 24 weeks
Time frame: Week 24
A fall will be counted if it will cause our participant(s) unintentionally coming to rest on the ground or other lower level.
31 secondary outcomes
Baseline Balance Ability
Time frame: Day 0
Changes from Baseline Balance Ability at 12 weeks
Time frame: Week 12
Changes from Baseline Balance Ability at 24 weeks
Time frame: Week 24
Baseline Functional Gait and Balance Assessment
Time frame: Day 0
Changes from Baseline Functional Gait and Balance Assessment at 12 weeks
Time frame: Week 12
Changes from Baseline Functional Gait and Balance Assessment at 24 weeks
Time frame: Week 24
Baseline Functional Gait Assessment
Time frame: Day 0
Changes from Baseline Functional Gait Assessment at 12 weeks
Time frame: Week 12
Changes from Baseline Functional Gait Assessment at 24 weeks
Time frame: Week 24
Baseline Flexibility
Time frame: Day 0
Changes from Baseline Flexibility at 12 weeks
Time frame: Week 12
Changes from Baseline Flexibility at 24 weeks
Time frame: Week 24
Baseline Muscle Strength
Time frame: Day 0
Changes from Baseline Muscle Strength at 12 weeks
Time frame: Week 12
Changes from Baseline Muscle Strength at 24 weeks
Time frame: Week 24
Baseline Agility
Time frame: Day 0
Changes from Baseline Agility at 12 weeks
Time frame: Week 12
Changes from Baseline Agility at 24 weeks
Time frame: Week 24
Preliminary Cognitive Function
Time frame: Day 0
Baseline Fear of Falling
Time frame: Day 0
Changes from Baseline Fear of Falling at 12 weeks
Time frame: Week 12
Changes from Baseline Fear of Falling at 24 weeks
Time frame: Week 24
Baseline Balance Confidence
Time frame: Day 0
Changes from Baseline Balance Confidence at 12 weeks
Time frame: Week 12
Changes from Baseline Balance Confidence at 24 weeks
Time frame: Week 24
Baseline Depression Levels
Time frame: Day 0
Changes from Baseline Depression Levels at 12 weeks
Time frame: Week 12
Changes from Baseline Depression Levels at 24 weeks
Time frame: Week 24
Baseline Anxiety Levels
Time frame: Day 0
Changes from Baseline Anxiety Levels at 12 weeks
Time frame: Week 12
Changes from Baseline Anxiety Levels at 24 weeks
Time frame: Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 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. This study is not recruiting at the moment.
Thomson Wong, PhD, BScPT principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
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.