Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000520538
Ethics application status
Approved
Date submitted
6/05/2015
Date registered
25/05/2015
Date last updated
2/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dancing for Parkinson’s disease
Scientific title
Dance Therapy for Parkinson’s Disease: A Feasibility Trial
Secondary ID [1] 286642 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 294968 0
Condition category
Condition code
Neurological 295230 295230 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Mixed dancing. Participants in the Mixed Dancing group will receive a 60 minute dancing class weekly for 8 weeks at a dance studio. The dance classes will be held by experienced dance teachers along with trained assistants. The mixed dancing group will include a preliminary warm up consisting of stretching, balance and postural exercises. The dancing class will use mixed dance genres such as jazz, ballet, tap dance, Irish dance, perform sitting on a chair and standing up. The sets will be chosen to improve range of movement, coordination, balance, rhythm, strength, gait and activities of daily living. The cool down will include stretching and relaxation exercises. Participants shall also do a simple and safe home program sitting on a chair once per week for 8 weeks at the time of the dancing classes. The participants will receive a DVD with 40 minutes of dance exercises based on the mixed classes to be perform at home.

Adherence will be monitored with participant's list, home program diary and exit questionnaire. All participants will complete a exit questionnaire after the program with question regarding the dance program.
Intervention code [1] 291785 0
Rehabilitation
Comparator / control treatment
Arm 2 - Tango. The other group will receive Argentine Tango classes for up to 60 minutes weekly for 8 weeks at a dance studio. The sessions will be held by a different dance teacher along with trained assistants. The protocol will include warm up, dance steps and cool down using Argentine Tango. Participants shall also do a simple and safe home program sitting on a chair once per week for 8 weeks at the time of the dancing classes. The participants will receive a DVD with 40 minutes of dance exercises based on the Tango classes to be perform at home.

Adherence will be monitored with participant's list, home program diary and exit questionnaire. All participants will complete a exit questionnaire after the program with question regarding the dance program.
Control group
Active

Outcomes
Primary outcome [1] 294982 0
The primary outcome for this trial is feasibility, which includes four specific sub types.

FEASIBILITY. The specific feasibility outcomes comprised (i) the number of people agreeing to participate in the dancing classes, (ii) the number who completed all pre-tests and follow up tests, (iii) compliance with each of the dancing classes and home programs and (iv) the number of adverse events.
Timepoint [1] 294982 0
Feasibility outcomes were assessed in different time points:
(i) the number of people agreeing to participate in the dancing classes - Recruitment and admission phases
(ii) the number who completed all pre-tests and follow up tests - Before intervention and after discharge
(iii) compliance with each of the dancing classes and home programs - During the eight weeks of intervention
(iv) the number of adverse events - During the eight weeks of intervention
Secondary outcome [1] 314501 0
Mobility - Timed up and Go
Timepoint [1] 314501 0
All participants were assessed two time: - Baseline - before dancing classes - After 8 weeks of the dance program
Secondary outcome [2] 314640 0
Freezing of gait - Freezing of gait questionnaire
Timepoint [2] 314640 0
All participants were assessed two time: - Baseline - before dancing classes - After 8 weeks of the dance program
Secondary outcome [3] 314641 0
Balance - Berg Balance Scale
Timepoint [3] 314641 0
All participants were assessed two time: - Baseline - before dancing classes - After 8 weeks of the dance program
Secondary outcome [4] 314642 0
Activities of daily living and motor impairment - UPDRS II and III
Timepoint [4] 314642 0
All participants were assessed two time: - Baseline - before dancing classes - After 8 weeks of the dance program
Secondary outcome [5] 314643 0
Quality of life - PDQ - 39
Timepoint [5] 314643 0
All participants were assessed two time: - Baseline - before dancing classes - After 8 weeks of the dance program
Secondary outcome [6] 314645 0
Safety of the dance program will be measured by the incidence of adverse events during the classes or home program. The adverse events will be described, as well as severity of injury, need for hospitalization and reason for withdrawal the program.
Timepoint [6] 314645 0
Over the 8 week intervention period participants will be monitored.
Secondary outcome [7] 323325 0
Gait and balance - Functional Gait Assessment.
Timepoint [7] 323325 0
All participants were assessed two time: - Baseline - before dancing classes - After 8 weeks of the dance program

Eligibility
Key inclusion criteria
Participants will have been clinically diagnosed with Parkinson's disease, be aged 20 to 85 years, male or female, Stage I - IV modified Hoehn and Yarh scale were included.
(mild to moderate impairment) and be without cognitive deficits (scores <24 on Mini Mental State Examination). People will need to be independently mobile and able to travel to the dance venue to be included. They will not receive any money for attending.
Minimum age
20 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are unable to walk six metres with assistance or gait aid or if they have pain. They will also be excluded if they have cognitive impairment as defined as a score of less than 24 on the Mini Mental Examination test, any neurological disease other than Parkinson's. Individuals who are unable to understand written and spoken English will be excluded.

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)
After screening procedure for eligibility and baseline testing, participants were randomized to one of the groups. A third party used the computer generated number sequence to allocate participants according to the baseline testing time. Sealed opaque envelopes were used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We used computer generated number sequences for randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
According to previous feasibility studies about dancing for PD at least 20 participants were determined to be required. The feasibility results were summarized using the Consort Statement Flow Diagram. We analysed the number of people recruited in a 2 month period, the number of these who agreed to participate in the dancing classes, the number who completed all pre-tests and follow-up tests, the compliance with each of the dancing classes and home programs (%) and the number and type of adverse events. We also analysed the data for the secondary variables from pre-test to post-test using Repeated measures ANOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/05/2015
Actual
2/05/2015
Date of last participant enrolment
Anticipated
Actual
6/07/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291215 0
University
Name [1] 291215 0
La Trobe University
Country [1] 291215 0
Australia
Funding source category [2] 291298 0
Government body
Name [2] 291298 0
CAPES Foundation, Ministry od Education of Brazil.

* One of the researchers (Priscila Alves da Rocha) received a scholarship from the Brazilian government for this research.
Country [2] 291298 0
Brazil
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University - Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country
Australia
Secondary sponsor category [1] 289976 0
Individual
Name [1] 289976 0
Professor Meg Morris
Address [1] 289976 0
La Trobe University - Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country [1] 289976 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292778 0
University Human Ethics Committee (UHEC) - La Trobe University
Ethics committee address [1] 292778 0
Ethics committee country [1] 292778 0
Australia
Date submitted for ethics approval [1] 292778 0
Approval date [1] 292778 0
22/04/2015
Ethics approval number [1] 292778 0
S15/22

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 433 433 0 0
/AnzctrAttachments/368483-S15-22 Approval.pdf

Contacts
Principal investigator
Name 56990 0
Ms Priscila Alves da Rocha
Address 56990 0
La Trobe University, Bundoora - Plenty Road & Kingsbury Drive, Melbourne VIC 3086

College Science, Health & Engineering
Country 56990 0
Australia
Phone 56990 0
+610435409284
Fax 56990 0
Email 56990 0
[email protected]
Contact person for public queries
Name 56991 0
Meg Morris
Address 56991 0
La Trobe University, Bundoora - Plenty Road & Kingsbury Drive, Melbourne VIC 3086

College Science, Health & Engineering
Country 56991 0
Australia
Phone 56991 0
+61 0433 405 662
Fax 56991 0
Email 56991 0
[email protected]
Contact person for scientific queries
Name 56992 0
Meg Morris
Address 56992 0
La Trobe University, Bundoora - Plenty Road & Kingsbury Drive, Melbourne VIC 3086

College Science, Health & Engineering
Country 56992 0
Australia
Phone 56992 0
+61 043 5409 284
Fax 56992 0
Email 56992 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
No additional documents have been identified.