Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001058763
Ethics application status
Approved
Date submitted
19/09/2013
Date registered
23/09/2013
Date last updated
23/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility, safety and efficacy of an Argentine tango dance intervention for people living with Parkinson's disease: a pilot study
Scientific title
A single group pilot study of the feasibility, safety and efficacy of an Argentine tango dance intervention for people living with Parkinson's disease
Secondary ID [1] 283261 0
nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Parkinson's Disease 290135 0
Condition category
Condition code
Neurological 290520 290520 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 290522 290522 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend 1 hour, twice weekly Argentine Tango dance classes for four weeks. Dance classes designed and led by professional dance instructor and supervised by experienced physiotherapists. Feasibility and safety of the intervention will be monitored throughout the intervention phase. At each session a form will be completed which will detail attendance and the recording of any adverse events such as falls, injuries and complaints of musculoskeletal pain.
Intervention code [1] 287988 0
Rehabilitation
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290541 0
Feasibility: including outcomes below
Recruitment: time taken, recruitment rate, ratio of those eligible vs. non-eligible. Adherence. Attrition. Safety: monitoring for adverse events and near misses, level of supervision required. Adverse events will include (but it not limited to) falls, injuries (sprains, strains, lacerations), complaints of musculoskeletal pain or discomfort. Near misses may include (but not limited to) slips or trips that do not result in a fall. Safety will be monitored by physiotherapist supervising the dance classes and recorded on a monitoring form that is completed at the end of each session.
Timepoint [1] 290541 0
Recruitment monitored over recruitment phases. Adherence, attrition and safety monitored and assessed over 4 week intervention period.
Secondary outcome [1] 304758 0
Gait speed and step length measured by timed 6m walk
Timepoint [1] 304758 0
at baseline and at end of 4 week intervention phase
Secondary outcome [2] 304759 0
Dynamic balance as measured by Mini BESTest
Timepoint [2] 304759 0
at baseline and at end of 4 week intervention phase
Secondary outcome [3] 304760 0
Depression as measured by the Beck Depression Inventory
Timepoint [3] 304760 0
at baseline and at end of 4 week intervention phase
Secondary outcome [4] 304761 0
Health related quality of life as measured by the EQ-5D
Timepoint [4] 304761 0
at baseline at end of 4 week intervention phase
Secondary outcome [5] 304762 0
Motor impairment as measured by MDS-UPDRS -III
Timepoint [5] 304762 0
at baseline and at end of 4 week intervention phase

Eligibility
Key inclusion criteria
1.Diagnosed with idiopathic Parkinson's Disease (PD) by a neurologist
2.Community-dwelling
3.Aged 18-75 years
4.Hoehn and Yahr stages I-III
5.Have their GP or neurologist sign a screening form confirming they are suitable and safe for participation in dance intervention
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Have a musculoskeletal, cardiopulmonary, neurological or other medical condition that makes them unsuitable to participate in low intensity exercise such as dance.
2.Cannot communicate in English
3.Cannot provide informed consent: Score less than 24 on the Mini Mental State Examination (MMSE)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Primary focus on feasibility and safety
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive for secondary outcomes

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/04/2013
Date of last participant enrolment
Anticipated
Actual
22/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287999 0
University
Name [1] 287999 0
La Trobe University
Country [1] 287999 0
Australia
Primary sponsor type
Individual
Name
Professor Meg Morris
Address
Faculty of Health Sciences
La Trobe University
Kingsbury Drive
Bundoora, VIC, 3086
Country
Australia
Secondary sponsor category [1] 286719 0
None
Name [1] 286719 0
Address [1] 286719 0
Country [1] 286719 0
Other collaborator category [1] 277628 0
Individual
Name [1] 277628 0
Laura Blandy
Address [1] 277628 0
La Trobe University
Kingsbury Drive
Bundoora
Victoria, 3086
Country [1] 277628 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289924 0
La Trobe University Faculty of Human Ethics Committee
Ethics committee address [1] 289924 0
La Trobe University
Kingsbury Drive
Bundoora
Vic, 3086
Ethics committee country [1] 289924 0
Australia
Date submitted for ethics approval [1] 289924 0
Approval date [1] 289924 0
22/04/2013
Ethics approval number [1] 289924 0
FHEC13/026

Summary
Brief summary
This pilot study will explore the feasibility and safety of an Argentine tango dance intervention. Will involve a single group pre-test/post-test design with 8 participant diagnosed with idiopathic Parkinson's disease. Participants will be invited to participate a 4 week dance intervention. Feasibility and safety outcomes will be monitored and assessed at throughout the intervention. Secondary outcomes (efficacy) of gait, balance, motor impairment, depression and HRQOL will be measured at baseline at 4 weeks. Results will inform a future RCT that will investigate the therapeutic benefits of a dance intervention for people with PD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43110 0
Prof Meg Morris
Address 43110 0
Faculty of Health Sciences
La Trobe University
Kingsbury Drive
Bundoora
Victoria, 3086
Country 43110 0
Australia
Phone 43110 0
+61 3 9479 6080
Fax 43110 0
Email 43110 0
[email protected]
Contact person for public queries
Name 43111 0
Prof Meg Morris
Address 43111 0
Faculty of Health Sciences
La Trobe University
Kingsbury Drive
Bundoora
Victoria, 3086
Country 43111 0
Australia
Phone 43111 0
+61 3 9479 6080
Fax 43111 0
Email 43111 0
[email protected]
Contact person for scientific queries
Name 43112 0
Prof Meg Morris
Address 43112 0
Faculty of Health Sciences
La Trobe University
Kingsbury Drive
Bundoora
Victoria, 3086
Country 43112 0
Australia
Phone 43112 0
+61 3 9479 6080
Fax 43112 0
Email 43112 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
EmbaseTherapeutic Argentine tango dancing for people with mild Parkinson's disease: A feasibility study.2015https://dx.doi.org/10.3389/fneur.2015.00122
N.B. These documents automatically identified may not have been verified by the study sponsor.