Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000199112
Ethics application status
Approved
Date submitted
6/02/2019
Date registered
12/02/2019
Date last updated
11/03/2019
Date data sharing statement initially provided
12/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does increased frequency of dance classes improve outcomes in people with Parkinson's disease?
Scientific title
Dance Exercises for Parkinson’s Rehabilitation: How Much is Enough?
Secondary ID [1] 297311 0
Nil
Universal Trial Number (UTN)
U1111-1228-0636
Trial acronym
ParkinDance
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 311416 0
Condition category
Condition code
Neurological 310043 310043 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multi-site trial of up to 80 people with Parkinson’s disease will be conducted in Melbourne and regional Victoria. The participants will be randomly allocated to dance therapy classes that are delivered either twice per week for 12 weeks (group A) or once per week for 12 weeks (group B). Group A, which receives dancing classes twice per week is the intervention group and Group B that receives dance classes once per week is the control group.

The dancing classes will be led by experienced dancing teachers who are trained to understand Parkinson’s disability and safety. The classes will emphasize movement, strength, flexibility and balance.

Dance Classes: The group dancing to music sessions will start with warm-up activities to music, such as arm movements, leg movements, trunk movements, head movements, stretching and toe-tapping while sitting. The participants will then be invited to do various simple dance steps and movements in sitting or standing or travelling across the room or dancing in time to a range of rhythmic music pieces and drumbeats, which will be tailored to participant abilities. They will then do a cool down, of gentle movements to music, breathing and relaxation. A number of rest periods will be included in the sessions, according to participant needs, and each session will last for approximately 45 to 60 minutes. The dancing classes for all participants will be conducted in a local dance studio (health and fitness facility).
Intervention code [1] 313567 0
Rehabilitation
Comparator / control treatment
Dancing classes once per week for 12 consecutive weeks will be provided to the control group.
Control group
Dose comparison

Outcomes
Primary outcome [1] 318948 0
The primary outcome measure will be movement speed, as measured by the time taken to walk 6 metres distance.
Timepoint [1] 318948 0
March - April 2019 (Baseline assessment) - T0
June - July 2019 (Immediately at the end of 12 weeks of intervention) - T1
August - September (One month after post-intervention) - T2
Secondary outcome [1] 366516 0
The balance will be measured using the Berg Balance Scale (BBS).
Timepoint [1] 366516 0
March - April 2019 (Baseline assessment) - T0
June - July 2019 (Immediately at the end of 12 weeks of intervention) - T1
August - September (One month follow up post-intervention) - T2
Secondary outcome [2] 366519 0
Functional mobility will be assessed using the Timed Up and Go test,

Timepoint [2] 366519 0
March - April 2019 (Baseline assessment) - T0
June - July 2019 (Immediately at the end of 12 weeks of intervention) - T1
August - September (One month follow up post-intervention) - T2
Secondary outcome [3] 366520 0
Disability will be assessed using the UPDRS instrument.

.
Timepoint [3] 366520 0
March - April 2019 (Baseline assessment) - T0
June - July 2019 (Immediately at the end of 12 weeks of intervention) - T1
August - September (One month follow up post-intervention) - T2
Secondary outcome [4] 366654 0
Quality of life outcome will be measured utilising the PDQ39 questionnaire.
Timepoint [4] 366654 0
March - April 2019 (Baseline assessment) - T0
June - July 2019 (Immediately at the end of 12 weeks of intervention) - T1
August - September (One month follow up post-intervention) - T2

Eligibility
Key inclusion criteria
1. Adult, older than 18 years
2. Diagnosed as having Parkinson's disease
3. Safe to participate in dancing exercises
4. Willingness to participate in community dancing classes for 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cognitive impairment as indicated by a Short Test of Mental Status score of less than 24/30
2. Unable to walk 10 metres independently
3. Delirium or Dementia
4. Hoehn & Yahr stages 4 or 5

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Repeated measures ANOVA will be used to analyse the data given that this is a two-group repeated measures design. Additionally, a series of paired-comparisons will be performed using the t-statistic. Equivalent non-parametric tests will be used in the event of non-normally distributed data. Also, descriptive data for all the outcome variables will be generated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2019
Actual
Date of last participant enrolment
Anticipated
8/06/2019
Actual
Date of last data collection
Anticipated
8/10/2019
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 25562 0
3127 - Surrey Hills

Funding & Sponsors
Funding source category [1] 301874 0
Charities/Societies/Foundations
Name [1] 301874 0
Parkinson's Victoria
Country [1] 301874 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 301624 0
Charities/Societies/Foundations
Name [1] 301624 0
Parkinson's Victoria
Address [1] 301624 0
587, Canterbury Rd, Surrey Hills VIC 3127
Country [1] 301624 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302566 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 302566 0
Ethics committee country [1] 302566 0
Australia
Date submitted for ethics approval [1] 302566 0
13/09/2017
Approval date [1] 302566 0
16/11/2017
Ethics approval number [1] 302566 0
HEC17-089

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

Contacts
Principal investigator
Name 90678 0
Prof Meg E. Morris
Address 90678 0
La Trobe University
Kingsbury Dr, Bundoora VIC 3086
Country 90678 0
Australia
Phone 90678 0
+61 3 9479 6080
Fax 90678 0
Email 90678 0
[email protected]
Contact person for public queries
Name 90679 0
Emma Collin
Address 90679 0
Parkinson's Victoria
587 Canterbury Road, Surrey Hills, VIC 3127
Country 90679 0
Australia
Phone 90679 0
+61 3 8809 0400
Fax 90679 0
Email 90679 0
[email protected]
Contact person for scientific queries
Name 90680 0
Arun Prasad Balasundaram
Address 90680 0
La Trobe University
Kingsbury Dr, Bundoora VIC 3086
Country 90680 0
Australia
Phone 90680 0
+61 0435101276
Fax 90680 0
Email 90680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data will not be made public due to patient confidentiality.


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
No additional documents have been identified.