Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000129684
Ethics application status
Not yet submitted
Date submitted
23/01/2014
Date registered
3/02/2014
Date last updated
3/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
We Think You Can Dance! A pilot randomised controlled trial for aged care residents with dementia.
Scientific title
In aged care residents with dementia, does a dance program, compared to a music and socialisation program, improve or maintain cognition?
Secondary ID [1] 283952 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 290976 0
Condition category
Condition code
Neurological 291319 291319 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment intervention will be delivered for 3 x 45 minute sessions a week for 16 weeks by a professional dancer/dance teacher.

Each small group session (n=8) of the We Think You Can Dance! program will have the following structure: 1) seated warm-up involving arms and hands, and foot and leg movements, 2) standing group dance combinations, 3) learning a sequence of choreographed movements partnering with the group leader or staff volunteer 4) cool down, 5) social dance. The program builds in complexity and range of movements over time, and has been designed to be achievable, fun and encourage social interactions.

Intervention code [1] 288641 0
Behaviour
Comparator / control treatment
The control intervention will be delivered for 3 x 45 minute sessions a week for 16 weeks by a professional dancer/dance teacher.

Each small group session (n=8) of the classical music and socialisation control program will be themed around a classical composer or instrument and comprise: 1) the facilitator greeting and welcoming each participant; 2) reading a short biography of the composer and information about each piece played; 3) playing music, 4) discussion of the piece of music by the group. The control group will provide additional attention for participants in a social setting, as well as the experience of listening to music.
Control group
Active

Outcomes
Primary outcome [1] 291311 0
Scores on the Severe Impairment Battery (Saxton, McGonigle-Gibson, Swihart & Boller, 1990).
Timepoint [1] 291311 0
Baseline and 16 and 24 weeks after commencement
Secondary outcome [1] 306487 0
ADCS-Clinical Global Impression of Change ratings (Schneider et al. 1997)
Timepoint [1] 306487 0
Baseline and 16 and 24 weeks after commencement
Secondary outcome [2] 306489 0
Score on the Short Physical Performance Assessment Battery (Guralnik et al. 1994)
Timepoint [2] 306489 0
Baseline and 16 and 24 weeks after commencement
Secondary outcome [3] 306490 0
Score on the Cohen-Mansfield Agitation Inventory (Cohen-Mansfield, Marx & Rosenthal, 1989)
Timepoint [3] 306490 0
Baseline and 16 and 24 weeks after commencement
Secondary outcome [4] 306499 0
Scores on the ADCS-Activities of Daily Living (Windblad, Kilander, Erikson et al, 2006)
Timepoint [4] 306499 0
Baseline and 16 and 24 weeks after commencement

Eligibility
Key inclusion criteria
50 years or older; dementia diagnosis (any type); able to walk three-meters unassisted (use of stick for security is allowable); not fully blind or deaf; English-speaking; not anticipated to leave the specified dementia unit in the residential facility in the next 6 months; Mini Mental State Examination score of 20 or less
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
limited life expectancy; floridly psychotic; general practitioner advice against exercise; very high falls risk defined as not being able to stand unaided, plus a recent history of any significant or multiple falls (i.e. a fall that lead to hospital presentation, and/or two or more falls in the last month); exhibiting behaviour presenting a risk to study personnel; under public guardianship with no person responsible to consent on their behalf.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Residential aged care facility staff shall invite residents, families and staff to attend an on-site information session about the trial. A presentation about the study will be given, and information sheets and consent forms will be distributed along with reply paid envelopes. It will be emphasised that participation is completely voluntary and that declining to participate will not influence care or employment conditions. Staff will also distribute information sheets and consent forms to residents and family members who cannot attend the information session. Residents and family members can contact the researchers directly for more information or return the consent forms.
After written consent or proxy written consent is obtained, 8 residents will be randomly assigned to the Dance program (intervention group) and 8 randomly assigned to the music and socialisation program (control group).
All care staff (estimate n = 6) who assist with the dance program shall be invited to participate in the process evaluation. Care staff (estimate n = 4) who know participating residents well will also be invited to answer some questions on the resident.
The person to determine eligibility for inclusion in the trial, e.g. collect consents and perform baseline assessments, will not be the same person to generate group allocation. Allocation will involve contacting a researcher at the University of NSW, rather than a researcher at the residential aged care facility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All residents will have an ID code and the statistician will use MINIM (a program for randomising participants to treatment groups in clinical trials by the method of minimisation - Evans, Day & Royston), to ensure equal allocation to groups by age, gender and MMSE score.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models will be conducted using SPSS to compare differences in changes over time on the outcome measures between the dance and music groups. Covariates will be: age; sex; past/present interest in dance/music; and baseline MMSE.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7710 0
2167 - Glenfield

Funding & Sponsors
Funding source category [1] 288588 0
University
Name [1] 288588 0
Centre for Healthy Brain Ageing, University of New South Wales.
Country [1] 288588 0
Australia
Primary sponsor type
Individual
Name
Dr. Lee-Fay Low
Address
Dementia Collaborative Research Centre
Room 303, Level 3 AGSM Building
University of New South Wales
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 287296 0
Individual
Name [1] 287296 0
Dr. Jess Baker
Address [1] 287296 0
Dementia Collaborative Research Centre
Room 304, Level 3 AGSM Building
University of New South Wales
Sydney NSW 2052
Country [1] 287296 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290451 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 290451 0
HREC
UNSW,
Sydney NSW 2052
Ethics committee country [1] 290451 0
Australia
Date submitted for ethics approval [1] 290451 0
25/11/2013
Approval date [1] 290451 0
Ethics approval number [1] 290451 0
HC13374

Summary
Brief summary
This study is a single-blind randomized controlled pilot of a cognitively-enriched dance intervention called “We Think You can Dance!” for aged care facility residents with dementia. Residents will be randomly assigned to the dance program (n=8) or passive listening to a classical music and socialisation control group (n=8), for three 45-minute sessions a week for 16 weeks. Assessments will be conducted before, immediately and 2 months after the 16 week intervention period. We hypothesise that residents who participate in the dance group will improve in cognition, clinical assessment of change, agitation, physical function and activities of daily living relative to the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45750 0
Dr Lee-Fay Low
Address 45750 0
Dementia Collaborative Research Centre
Room 303, Level 3 AGSM Building
University of New South Wales
Sydney NSW 2052
Country 45750 0
Australia
Phone 45750 0
+ 61 (0)2 9385-2599
Fax 45750 0
Email 45750 0
lf.low@unsw.edu.au
Contact person for public queries
Name 45751 0
Dr Jess Baker
Address 45751 0
Dementia Collaborative Research Centre
Room 304, Level 3 AGSM Building
University of New South Wales
Sydney NSW 2052
Country 45751 0
Australia
Phone 45751 0
+61 (0) 2 9385 2605
Fax 45751 0
Email 45751 0
jessica.baker@unsw.edu.au
Contact person for scientific queries
Name 45752 0
Dr Jess Baker
Address 45752 0
Dementia Collaborative Research Centre
Room 304, Level 3 AGSM Building
University of New South Wales
Sydney NSW 2052
Country 45752 0
Australia
Phone 45752 0
+61 (0) 2 9385 2605
Fax 45752 0
Email 45752 0
jessica.baker@unsw.edu.au

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

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