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Trial registered on ANZCTR


Trial ID
ACTRN12613000782730
Ethics application status
Approved
Date submitted
30/05/2013
Date registered
12/07/2013
Date last updated
12/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Dancing Mind: cognitive benefits of multi-dimensional physical activity in older adults
Scientific title
The Dancing Mind: cognitive benefits of multi-dimensional physical activity in old age
Secondary ID [1] 282499 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive decline in older adults (>60) 289152 0
fitness in older adults (>60) 289153 0
Depression and anxiety in older adults (>60) 289206 0
Quality of life in older adults (>60) 289207 0
Condition category
Condition code
Neurological 289480 289480 0 0
Dementias
Public Health 289535 289535 0 0
Health promotion/education
Mental Health 289893 289893 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 intervention - ballroom dancing twice weekly for 1 hour over 9 months. A collection of dances such as Rock and Roll, Foxtrot, Waltz and some Latin (Salsa and Rumba) will be taught in the course. A common principle is that each dance can be taught at various levels of complexity (eg. Foxtrot: Basic steps, Promenade, Rock Turn, and Sway). The program will be held in a dance studio or community hall. Intensity levels during dance classes will be measured by accelerometers and the Perceived Physical Effort scale (PPE). The program will be standardised across all studios and will be delivered by accredited dance Instructors who will attend three 1-hour workshops, at start and two 3-month apart led by the program coordinator. In the workshops teachers will receive the program resources for the next two months (CDs and workbook, raise problems encountered in previous stage and discuss class progress).
Intervention code [1] 287154 0
Prevention
Intervention code [2] 287205 0
Lifestyle
Comparator / control treatment
Arm 2 – will receive a combination of a home and group-based walking program at the same dose of intervention (2 x 1 hour sessions) over 9 months. The walking program will involve some "cognitive tasks", using pedometers and accelerometers, and will provide opportunity to socialise by walking in teams.
The walking program consists of three stages, each stage last 12 weeks. Group meetings will be held once every fortnight in a designated park in the area, the complementary walks of the week can be done at different parks according to participants’ residential areas and will be encouraged to work in teams or pairs.
In the first stage participants will engage in short walk at a convenient pace with a focus on a pedometer. The intermittent walks (10min*3) or (15min *2) or (20min*2) during a session of an hour in which they observe: 1) the number of steps undertaken at each interval 2) distance of the intermittent walks at an easy pace using their stride length entered and saved in their pedometers and 3) the approximation of calories expended during those intermittent walks using their body weight saved in their pedometer. Participants will repeat without the instructor what they have done in the last fortnight session. In the second stage (week 13-24) participants will engage in longer walks (30 minutes -45minutes) without interruption at a convenient pace (with pedometers) and will learn the principles of assessing perceived effort using the Borg scale, heart reserve, and objective measurement of intensity of the walk by wearing accelerometers. They will receive personal feedback on the intensity measured during this walks. The aim is to maintain similar effort to dance classes. In the third stage (week 25-36) the focus of the program will shift to brisk walking (with pedometer & accelerometer) ; participants will practice increasing the number of steps undertaken in 10 minutes compare to first stage - establishing individual 's "brisk walk" equivalent steps per 10 minutes and will engage in intervals of walking at brisk and convenient pace for one hour.
Control group
Active

Outcomes
Primary outcome [1] 289632 0
Trial Making Test part A (TMT-A) and part B (TMT-B): Part A measures processing speed and involves the participant connecting consecutive numbers. Part B is a measure of executive function of "task-shifting" and involves participant connecting a series of circles alternating between letters and numbers (e.g. 1-A-2-B-3-C). Time (seconds) to complete each test is recorded and the difference in time between TMTB and A will be used as indication of executive function .
Timepoint [1] 289632 0
The second baseline measurement (3 weeks from baseline) will be compared to 9 months measurement . This is to wash out the effect of improvement due to "learning" from repetition.
Primary outcome [2] 289674 0
The Stroop Color-Word Test is measuring the person’s ability to suppress automatic reactions in favour of alternative choice reactions, and is indicative of mental flexibility. It requires concentration and ability to ward off distractions. Participants are shown a page with Color-Word printed in non-matching ink (i.e. the word BLUE is printed in red). In the first part they are asked to read a list of words and the time it takes is recorded. In the second part they are asked to name the ink color in which the word are printed (i.e., ignoring the word itself). The score is the number of correct words
Timepoint [2] 289674 0
The second baseline measurement will be conducted 3 weeks following the initial baseline measurement and will be compared to 9 month measurement session.
Primary outcome [3] 289675 0
Digit Span Backward (DSB) will be used to measure working memory. The tests involved recalling digits in reverse order (DSB). Seven pairs of random number sequences are read to participants. The sequence begins with three digits and increase by one at a time up to 9 digits. The number of correctly recalling sets (range from 0-14) are recorded.
Timepoint [3] 289675 0
The second baseline measurement will be conducted 3 weeks following the initial baseline measurement and will be compared to 9 month measurement session.
Secondary outcome [1] 302896 0
Colour Choice Reaction Time (CRTC): 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 accuracy for each of 60 trials.
Timepoint [1] 302896 0
The second baseline measurement will be conducted 3 weeks following the initial baseline measurement and will be compared to 9 month measurement session.
Secondary outcome [2] 302983 0
Stroop Step Choice Reaction Time measures response inhibition and selective attention. For this test eight panels on the dance mat are used: 2 central stance panels, 2 front panels, 1 left panel, 1 right panel and 2 back panels. In the centre of the computer screen an arrow is presented pointing in one of four directions (up, down, left, right) that match the four possible step directions (forward, backward, left, right). Inside the arrow is a written word indicating a direction different to that indicated by the arrow. Participants have to step according to the word (ignoring the direction of the arrow) and then return to the centre panels. After 4 practice trials with one step in each direction, a random sequence of 20 trials in which the directions of word and shape never match commences. Participants step with the left foot to the left panel, with the right foot to the right panel and with either foot to the front and back panels. If participants step on a wrong panel they have to repeat the trial until they step correctly. In each of the three tests, reaction time measured from stimulus occurrence to movement initiation (lift off); movement time measured from movement initiation to step finalisation (step down) and stepping errors are measured.
Timepoint [2] 302983 0
The second baseline measurement will be conducted 3 weeks following the initial baseline measurement and will be compared to 9 month measurement session.

Eligibility
Key inclusion criteria
Participants must be >60 years of age, be able to walk unaided for at least 50 meters. Participants must also have GP clearance if they suffer from unstable chronic condition limiting their participation in regular exercise (e.g. unstable ischemic heart condition, hypertension, Parkinson's Disease, debilitating arthritis)
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants should have not practiced dance in the past year.

Participants should not have significant cognitive impairment determined by less than 21 points on the TICS, which is the telephone modification of the Mini-Mental Cognitive Status Examination (MMSE; equivalent to 24).

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)
1. Determine if the participant is eligible for the study -
2. Participants at risk completes the consent form and gets GP clearance to participate in moderate physical activity
3. Complete first baseline measures - time_0 - baseline, time_1 - about 3 weeks following time 0 measurements.
3. Using sealed opaque envelopes eligible participants who completed two baseline measurements and consented will be randomized.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The group allocation scheme used randomized permuted blocks using computer –generated random numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on previous research, aerobic exercise with simultaneous cognitive stimulation achieved an effect size of 0.5 on executive functioning tests in comparison to aerobic training only. We assumed that Dance as aerobic and mental activity will achieved this effect over walking on the main executive functions tests. Power analysis was therefore based on this effect size and an attrition rate of 18%, yields a sample size of 126 (power=.80, alpha=.05). The difference in change in scores between the two groups will be initially tested by an independent t-test of the change scores (i.e., second baseline measurement to 9 months). Further analyses using linear mixed models for continuous outcomes and generalized linear mixed models for discrete outcomes with group allocation as the between-subjects effect will allow for simultaneous comparisons across all three time points with the inclusion of covariates. An intention-to-treat approach will be taken.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287285 0
Charities/Societies/Foundations
Name [1] 287285 0
Illawarra Retirement Trust
Address [1] 287285 0
Physical Address Lvl 3, 77 Market St, Wollongong, NSW 2500
Postal Address P O Box 2106, Wollongong DC, NSW 2500
Country [1] 287285 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Dafna Merom
Address
School of Biomedical and Health Sciences,
Building 24, Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith, NSW, 2751
Country
Australia
Secondary sponsor category [1] 286044 0
None
Name [1] 286044 0
Address [1] 286044 0
Country [1] 286044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289299 0
University of Western Sydney
Ethics committee address [1] 289299 0
Office of Research Services
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 289299 0
Australia
Date submitted for ethics approval [1] 289299 0
Approval date [1] 289299 0
16/01/2013
Ethics approval number [1] 289299 0
H9987

Summary
Brief summary
We propose to test if simultaneous engagement in activity that is multi-dimensional and synergetic in nature, such as dance, can prevent cognitive declines in old age. Dance is a complex sensorimotor activity combined with cognitive, social and affective dimensions. We offer to compare the executive functioning, working memory and processing speed of 126 older adults (aged 60 years and older), with or without mild cognitive declines, who will be randomised to participate in either 9 months, 2 weekly sessions of 1) ballroom dancing or 2) group walking program, as a functional uni-dimensional accessible and most popular form of exercise. Second we will compare changes in fitness levels between the groups and whether cognitive benefits can be attributed to improve in fitness. Last, the experience and the satisfaction from the two programs will be evaluated using qualitative and quantitative methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40030 0
A/Prof Dafna Merom
Address 40030 0
School of Biomedical and Health Sciences,
Building 24, Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith, NSW, 2751
Country 40030 0
Australia
Phone 40030 0
+61409044976
Fax 40030 0
Email 40030 0
d.merom@uws.edu.au
Contact person for public queries
Name 40031 0
Miss Jade McNeill
Address 40031 0
School of Biomedical and Health Sciences,
Building 24, Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith, NSW, 2751
Country 40031 0
Australia
Phone 40031 0
+61410844776
Fax 40031 0
Email 40031 0
jade.mcneill@uws.edu.au
Contact person for scientific queries
Name 40032 0
A/Prof Dafna Merom
Address 40032 0
School of Biomedical and Health Sciences,
Building 24, Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith, NSW, 2751
Country 40032 0
Australia
Phone 40032 0
+61409044976
Fax 40032 0
Email 40032 0
d.merom@uws.edu.au