Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563661
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
A Specific Dance Intervention in Older Adults in Hong Kong
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 Kongs 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 Kongs 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 Kongs 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 N100 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 n50 or the wait-list control group WLCG n50 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 2528 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 2528 in the POMA The exclusion criteria will be 1 a total score of less than 2430 in the Chinese version of the Mini-Mental State Examination MMSE-C 2 the existence of any untreated cerebral vascular disease Parkinsons 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 eg 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 participants 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 eg 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 eg 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 programmes 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 participants 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 ie 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 ie 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 eg taking more than 135 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 eg knee and hip extensors will be measured using the well-recognised Lafayette manual muscle testing system eg 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
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 eg 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 participants 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 eg 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 eg 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 programmes 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 participants 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 ie 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 ie 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 eg taking more than 135 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 eg knee and hip extensors will be measured using the well-recognised Lafayette manual muscle testing system eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None