Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000889853
Ethics application status
Approved
Date submitted
13/08/2012
Date registered
21/08/2012
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of social dancing as a strategy to prevent falls in older people
Scientific title
Evaluation of social dancing compared to wait list controls in reducing incidence of falls in older people
Secondary ID [1] 280427 0
Nil
Universal Trial Number (UTN)
U1111-1130-3798
Trial acronym
DAnCE (Dance, AgeiNg, Cognition and Economics) fall prevention trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of falls in older adults 286395 0
Prevention of cognitive decline in older adults 286396 0
Condition category
Condition code
Musculoskeletal 286649 286649 0 0
Other muscular and skeletal disorders
Mental Health 286650 286650 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 287469 287469 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Social Dancing (folk and ballroom dancing) in groups delivered by certified dance instructors with particular experience in teaching older adults. The classes are 1-hour long delivered twice weekly, in total 80 hours over 12 months.
Intervention code [1] 284787 0
Prevention
Intervention code [2] 284788 0
Lifestyle
Comparator / control treatment
Participants in the control group will be advised to continue with their regular activities. They will receive monthly newsletters containing study updates, “meet the team” section and health education section. The topics for the educational sections are: Vitamin D, sleeping habits, Healthy eating, Smoking cessation, Appropriate footwear, Reducing alcohol intake, Falls statistics, Aging and the mind, Keeping the mind sharp, Sitting for too long, it is never too old to start, and the Origin of ballroom/folk dance.
Controls will be placed on a wait list for the dance classes. Controls will receive 80 hours of dance classes at the completion of the trial.
Control group
Active

Outcomes
Primary outcome [1] 287052 0
Number of accidental falls per participant. Falls will be recorded monthly for 12 months on a diary (calendar) and be collected by mail. Participants will need to record 'F' (i.e., if a Fall) or 'N' (no fall) every day of the month. Every reported fall will be further contacted by phone to complete details about that fall (where was it, did it ended with injury, type of injury and treatment if applicable). Participants with missing diaries will be contacted by phone, fill the diary with the researcher and will be asked also to mail the diary.
In addition, the monthly diary will collect information on utilization of health services for economic evaluation using a list of codes that is printed on the calendar; a visit to GP, any use of a specialist (i.e., physiotherapists, consultation with medical specialist) , visit to an outpatient Clinic, Emergency room, use of ambulance and whether there was a change in medications reported at baseline.
Timepoint [1] 287052 0
12 months
Primary outcome [2] 287053 0
Cognitive function - Trail Making Test A and B
Time to complete the Trail Making Test (TMT, part A and B) will be assessed. The TMT A and B is an executive functioning tests. Part A measures processing speed and involves participants connecting consecutive numbers (e.g., 1-2-3), and Part B is a measure of executive function of ?task shifting? and involves participants connecting alternating letters and numbers (e.g.,1-A-2-B). The difference in time between the two parts will be calculated to isolate the executive component of this test.
Timepoint [2] 287053 0
12 months
Secondary outcome [1] 297273 0
Physiological Profile Assessment (PPA). The PPA comprises of five tests which provide an overall falls risk score: Vision (edge contrast sensitivity), peripheral sensation (proprioception), lower extremity strength (knee extension), simple reaction time using figure press as the response, and body sway when standing on the medium-density foam rubber mat, which is a measure of balance.
Timepoint [1] 297273 0
12 months
Secondary outcome [2] 297274 0
Choice Stepping Reaction Time Tests without and with cognitive load. Three short tests which requires the subject to perform quick, correctly targeted steps in response to visual cues. The tests comprises of arrows appear randomly on a computer screen. The arrows have graphical presentations on a dance MAT (front left, front right, side left, side right).
Test 1: Participants are asked to step as quickly as possible onto the corresponding arrow of the mat and returned to the centre. The time to react and the time it takes to return to the centre is recorded using a customised software.
This test measures The tests measure visual attention, central processing, reaction time and movement time.
Test 2: Similar test are then performed but with a no-go task which determine by the colour of the errors (i.e., blue color to inhibit response). The time it takes to respond and step back plus the number of errors are recorded. This test also measures as above plus response inhibition.
Test 3: this test is the modification of the Stroop Color-Word to a motion. Participants are shown "congruent arrow" (i.e., the direction of the arrow and the word "front" are similar) and incongruent step by the word. Time and errors are recorded. This test measures response inhibition and selective attention which is an executive function measure.
Timepoint [2] 297274 0
12 months
Secondary outcome [3] 298740 0
Colour Choice Reaction Time Test - this test requires minimal locomotion but measures reaction time with response inhibition. The test involves the presentation of targets of different colours in one of four cells in a square grid. Participants respond to targets by using hand buttons or foot pedals. Blue target requires a response inhibition (i.e., not pressing any buttons). The computer recorded reaction times and errors (accuracy).
Timepoint [3] 298740 0
12 Months
Secondary outcome [4] 298741 0
Rey Auditory Verbal Learning test (RAVLT). The test evaluates verbal learning and memory, including proactive inhibition, retroactive inhibition, retention, encoding versus retrieval, and subjective organisation. The test starts with a list of 15 words, which an examiner reads aloud at the rate of one per second. The participant's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then the examiner presents a second list of 15 words, allowing the participant only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list.
Timepoint [4] 298741 0
12 months
Secondary outcome [5] 298742 0
The Short Physical Performance Battery (SPPB) measures lower limb functional status by assessing balance, gait, strength and endurance of the lower extremities. The tests include side-by-side, semi-tandem, and tandem standing tests to complete 10 seconds, time to complete 3-meter walk at normal speed , and a timed sit-to-stand 5 repeat.
Timepoint [5] 298742 0
12 months
Secondary outcome [6] 298743 0
Self-reported Quality of Life questionnaires- SF12/SF6
Timepoint [6] 298743 0
3 months and 12 months
Secondary outcome [7] 298841 0
Self-reported Quality of life questionnaire - ICECAP-O
Timepoint [7] 298841 0
3 months and 12 months
Secondary outcome [8] 298842 0
$ per fall prevented.
Costs for total health care resource utilisation, rather than only falls-related healthcare utilisation will be collected monthly for 12 months. Participants will report on the falls diaries any inpatient hospital admissions, Emergency department visits, Ambulance trips, Doctor and allied health visits, prescribed medications, Home care / nursing care,Nursing home or long term care admission. The cost for each of these item will be extrapolated from the relevant source (e.g., Medicare Benefits Scheme fee for service, PBS for medications, etc..). Participant out-of-pocket costs and care provided by family and /or friends will not be included.
The cost of the trial is itemized in the trial budget.
Timepoint [8] 298842 0
12 months

Eligibility
Key inclusion criteria
1) self care retirement villages with 60 or more residents.
2) resident of a selected self care village
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Unstable medical condition involving the neuromuscular, skeletal or cardiovascular system
2) Mini-mental state examination score <24 indicating cognitive impairment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All 126 retirement villages in Sydney Greater Metropolitan Area will be contacted by letter to determine eligibility and interest in participating. The first 28 eligible and interested villages to respond will be invited to participate in the trial. Invitations will be sent to all residents of the participating villages, and an information session will be held in order to recruit individual participants. Researchers will attend the retirement village and conduct a telephone screening with potential participants. Once eligibility is established, baseline measures will be collected. Once recruitment and baseline data collection at each village is complete, that village will be randomised. Randomisation will be by minimisation of two of the baseline variables (physiological performance assessment “FallScreen” and Trail Making Part B) which are associated with the primary outcome. The randomisation will be performed by the study statistician using a computer program that allocates the village with probability 0.8 to the group that minimises the imbalance of these variables between intervention and control groups. The study co-ordinator will telephone the study statistician and be advised of the village’s allocation, and will arrange for the delivery of the intervention if appropriate. Allocation will thus be concealed from the research team recruiting villages and participants, as randomisation will occur after baseline measures have been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation using minimisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomised trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2012
Actual
5/09/2012
Date of last participant enrolment
Anticipated
31/08/2013
Actual
26/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
460
Accrual to date
Final
530
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285185 0
Government body
Name [1] 285185 0
NHMRC
Country [1] 285185 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
School of Science and Health Building 24 Level 4 Rm.30
Campbelltown campus
University of Western Sydney
Locked bag 1797 Penrith NSW 2751, Australia
Country
Australia
Secondary sponsor category [1] 284053 0
University
Name [1] 284053 0
University of Sydney
Address [1] 284053 0
School of Public Health
Edward Ford Building (A27)
University of Sydney, 2006
Country [1] 284053 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287192 0
University of Western Sydney
Ethics committee address [1] 287192 0
Ethics committee country [1] 287192 0
Australia
Date submitted for ethics approval [1] 287192 0
Approval date [1] 287192 0
19/03/2012
Ethics approval number [1] 287192 0
H9468

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34128 0
A/Prof Dafna Merom
Address 34128 0
Western Sydney University
Locked Bag 1797, Penrith NSW 2751, Australia
Country 34128 0
Australia
Phone 34128 0
+61 2 4620 3796
Fax 34128 0
+61 2 4620 3710
Email 34128 0
[email protected]
Contact person for public queries
Name 17375 0
Associate Professor Dafna Merom
Address 17375 0
University of Western Sydney

Locked bag 1797 Penrith NSW 2751, Australia
Country 17375 0
Australia
Phone 17375 0
+61 2 46203796
Fax 17375 0
Email 17375 0
[email protected]
Contact person for scientific queries
Name 8303 0
Associate Professor Dafna Merom
Address 8303 0
University of Western Sydney

Locked bag 1797 Penrith NSW 2751, Australia
Country 8303 0
Australia
Phone 8303 0
+61-2-46203796
Fax 8303 0
Email 8303 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSocial Dancing and Incidence of Falls in Older Adults: A Cluster Randomised Controlled Trial.2016https://dx.doi.org/10.1371/journal.pmed.1002112
N.B. These documents automatically identified may not have been verified by the study sponsor.