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Trial registered on ANZCTR


Registration number
ACTRN12624000446561
Ethics application status
Approved
Date submitted
18/03/2024
Date registered
11/04/2024
Date last updated
30/06/2024
Date data sharing statement initially provided
11/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Progressive strength training incorporating modified powerlifting for people with early onset Parkinson's disease.
Scientific title
Gym-Based Progressive Resistance Training for People with Early Onset Parkinson's Disease: A Clinical Trial
Secondary ID [1] 311701 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 333166 0
Condition category
Condition code
Neurological 329862 329862 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 330034 330034 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twice-weekly progressive resistance exercise sessions incorporating modified powerlifting in a community gym setting.
Exercise sessions will be directly supervised by exercise trainers employed at the community gym. All exercise trainers supervising participants will have undergone an education and training program.
Exercise sessions will be delivered one-to-one.
The level of intensity will matched to participant abilities, with monitoring by the exercise trainer and feedback from the participant using rate of perceived exertion (RPE).
The sessions will run for up to one hour each time.
Each participant will be scheduled for two sessions per week for eight consecutive weeks.
Attendance will be recorded for each session on a checklist.
Intervention code [1] 328165 0
Rehabilitation
Intervention code [2] 328272 0
Treatment: Other
Intervention code [3] 328273 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337638 0
Feasibility (safety)
Timepoint [1] 337638 0
Baseline and daily (as required) over the course of the 8 week intervention program.
Primary outcome [2] 337793 0
Recruitment /retention of people with early onset Parkinson’s disease
Timepoint [2] 337793 0
Baseline and daily (as required) over the course of the 8 week intervention program.
Primary outcome [3] 337794 0
Feasibility (access to physical infrastructure and resources )
Timepoint [3] 337794 0
Baseline and daily (as required) over the course of the 8 week intervention program.
Secondary outcome [1] 432606 0
Disability
Timepoint [1] 432606 0
Baseline and 8 weeks after baseline
Secondary outcome [2] 432607 0
Quality of Life
Timepoint [2] 432607 0
Baseline and 8 weeks after baseline
Secondary outcome [3] 432608 0
Health status
Timepoint [3] 432608 0
Baseline and 8 weeks after baseline
Secondary outcome [4] 432609 0
Strength
Timepoint [4] 432609 0
Baseline and 8 weeks after baseline
Secondary outcome [5] 433339 0
PRIMARY OUTCOME: Feasibility (staffing)
Timepoint [5] 433339 0
Baseline and daily (as required) over the course of the 8 week intervention program
Secondary outcome [6] 433340 0
PRIMARY OUTCOME: Feasibility (adherence to session program schedules)
Timepoint [6] 433340 0
Baseline and daily (as required) over the course of the 8 week intervention program.
Secondary outcome [7] 433341 0
PRIMARY OUTCOME: Feasibility (cost of delivering powerlifting program)
Timepoint [7] 433341 0
Baseline and daily (as required) over the course of the 8 week intervention program.
Secondary outcome [8] 433342 0
PRIMARY OUTCOME: Feasibility (participant perceptions on acceptability, benefits and limitations)
Timepoint [8] 433342 0
Within one-week of each participants final assessment (8 weeks from baseline)

Eligibility
Key inclusion criteria
Participants must be adults diagnosed with early onset Parkinson's disease and be able to attend a community gym in Australia for exercise. They need to be proficient in English and be willing and able to provide informed consent. All participants will need to have confirmation from a medical practitioner confirming their suitability for engaging in progressive resistance strength training, including modified powerlifting.
Minimum age
18 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have other neurological disorders, comorbidities impacting gait or impeding safe exercise, orthostatic hypotension, heart conditions, lung conditions, musculoskeletal conditions (e.g., back pain or arthritis), injuries, uncontrolled diabetes, mood disorders, chronic fatigue syndrome, cognitive dysfunction, unmanaged medical or surgical conditions, severe auditory or visual impairment, cancer, obesity, bone disease, or currently receiving deep brain stimulation or using Parkinson’s medication pumps.

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
Safety/efficacy
Statistical methods / analysis
This feasibility trial will include 10 people with early-onset Parkinson's disease and all will be offered training twice per week for 8 consecutive weeks in a community gym.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/04/2024
Actual
5/06/2024
Date of last participant enrolment
Anticipated
30/12/2024
Actual
Date of last data collection
Anticipated
24/06/2025
Actual
Sample size
Target
10
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316031 0
Charities/Societies/Foundations
Name [1] 316031 0
Bethlehem Griffith Research Foundation
Country [1] 316031 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 318186 0
None
Name [1] 318186 0
Address [1] 318186 0
Country [1] 318186 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314853 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 314853 0
Ethics committee country [1] 314853 0
Australia
Date submitted for ethics approval [1] 314853 0
12/02/2024
Approval date [1] 314853 0
13/03/2024
Ethics approval number [1] 314853 0
HEC24036

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

Contacts
Principal investigator
Name 132934 0
Prof Meg Morris
Address 132934 0
La Trobe University, 1 Kingsbury Drive Bundoora VIC 3086
Country 132934 0
Australia
Phone 132934 0
+61433405662
Fax 132934 0
Email 132934 0
[email protected]
Contact person for public queries
Name 132935 0
Meg Morris
Address 132935 0
La Trobe University, 1 Kingsbury Drive Bundoora VIC 3086
Country 132935 0
Australia
Phone 132935 0
+61433405662
Fax 132935 0
Email 132935 0
[email protected]
Contact person for scientific queries
Name 132936 0
Meg Morris
Address 132936 0
La Trobe University, 1 Kingsbury Drive Bundoora VIC 3086
Country 132936 0
Australia
Phone 132936 0
+61433405662
Fax 132936 0
Email 132936 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
Because there are only 10 people with a rare condition this could put them at risk of identification. It is essential to maintain confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21835Study protocol  [email protected]



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.