Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000186651
Ethics application status
Approved
Date submitted
7/02/2023
Date registered
22/02/2023
Date last updated
14/01/2024
Date data sharing statement initially provided
22/02/2023
Date results provided
22/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the Parkinson's Disease (PD) Warrior 10 week challenge exercise program for Parkinson's Disease improve quality of life and objective outcome measures?
Scientific title
Does the PD Warrior program improve Quality of Life and objective outcome measures in Parkinson's Disease?
Secondary ID [1] 308927 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 328938 0
Condition category
Condition code
Neurological 325925 325925 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 326006 326006 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. PD Warrior 10 week challenge exercise program
This high intensity exercise program is supervised by a physiotherapist or exercise physiologist who is a trained PD Warrior Instructor. Groups have a maximum of 10 participants. The high intensity is assessed by RPE.
Participants are required to attend a 60 minute class once a week for 10 weeks and complete daily home exercises for 10-15 minutes.
Participants are given a workbook prior to the start of classes and their home exercises are checked at each class. The workbook is only available to participants who attend a licensed PD warrior facility to complete the 10 week challenge exercise program and was compiled by the founders of the PD Warrior program.
2. Example of exercise is : Squat and stop exercise - focusses on power squatting to strengthen legs and lower back as well as full extension and amplitude in arms and hands.
Intervention code [1] 325376 0
Rehabilitation
Intervention code [2] 325377 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333766 0
Quality of Life - PDQ39 questionnaire
Timepoint [1] 333766 0
Immediately pre commencement and post completion of the PD Warrior 10 week challenge exercise program
Primary outcome [2] 333769 0
MDS Unified Parkinson's Disease Rating Scale Part III Motor Examination
Timepoint [2] 333769 0
Immediately pre commencement and post completion of the PD Warrior 10 week challenge exercise program
Secondary outcome [1] 418234 0
10 metre walk test - walking speed
Timepoint [1] 418234 0
Immediately pre commencement and post completion of the PD Warrior 10 week challenge exercise program
Secondary outcome [2] 418235 0
Parkinson's Kinetigraph to track and analyse specific PD symptoms and provides quantitative measures of bradykinesia, dyskinesia, tremor and motor fluctuations during activities of daily living and in the patient’s home environment
Timepoint [2] 418235 0
Worn for 7 days pre and post the PD Warrior 10 week challenge exercise program
Secondary outcome [3] 418549 0
6 minute walk test - distance walked
Timepoint [3] 418549 0
Immediately pre commencement and post completion of the PD Warrior 10 week challenge exercise program
Secondary outcome [4] 418550 0
Timed Up and Go test-time taken
Timepoint [4] 418550 0
Immediately pre commencement and post completion of the PD Warrior 10 week challenge exercise program
Secondary outcome [5] 418551 0
Timed fine motor tests with hand
Timepoint [5] 418551 0
Immediately pre commencement and post completion of the PD Warrior 10 week challenge exercise program
Secondary outcome [6] 418552 0
MiniBESTest balance test
Timepoint [6] 418552 0
Immediately pre commencement and post completion of the PD Warrior 10 week challenge exercise program

Eligibility
Key inclusion criteria
1. Confirmed diagnosis of PD by a neurologist or PD geriatrician
2. Availability to complete the full 10-week program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Documented history of cognitive problems, falls or mobility limitations related to other factors such as musculoskeletal impairment

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/12/2020
Date of last participant enrolment
Anticipated
Actual
28/06/2021
Date of last data collection
Anticipated
Actual
18/10/2021
Sample size
Target
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 313137 0
Hospital
Name [1] 313137 0
Hollywood Private Hospital
Country [1] 313137 0
Australia
Primary sponsor type
Individual
Name
Ms Claire Tucak
Address
Hollywood Private Hospital
115 Monash Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 314838 0
Individual
Name [1] 314838 0
Dr Julian Rodrigues
Address [1] 314838 0
Hollywood Private Hospital
115 Monash Avenue
Nedlands WA 6009
Country [1] 314838 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312381 0
Ramsay Health Care WA/SA HREC
Ethics committee address [1] 312381 0
Ethics committee country [1] 312381 0
Australia
Date submitted for ethics approval [1] 312381 0
Approval date [1] 312381 0
30/10/2020
Ethics approval number [1] 312381 0

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

Contacts
Principal investigator
Name 124458 0
Dr Julian Rodrigues
Address 124458 0
Hollywood Private Hospital
Level 3, Suite 303/91 Monash Avenue
Nedlands WA 6009
Country 124458 0
Australia
Phone 124458 0
+61 08 94204900
Fax 124458 0
Email 124458 0
[email protected]
Contact person for public queries
Name 124459 0
Claire Tucak
Address 124459 0
Hollywood Private Hospital
Monash Avenue
Nedlands WA 6009
Country 124459 0
Australia
Phone 124459 0
+61 8 9346 6932
Fax 124459 0
Email 124459 0
[email protected]
Contact person for scientific queries
Name 124460 0
Claire Tucak
Address 124460 0
Hollywood Private Hospital
Monash Avenue
Nedlands WA 6009
Country 124460 0
Australia
Phone 124460 0
+61 8 9346 6932
Fax 124460 0
Email 124460 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
Nil


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.