Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
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.
Query!
Scientific title
Gym-Based Progressive Resistance Training for People with Early Onset Parkinson's Disease: A Clinical Trial
Query!
Secondary ID [1]
311701
0
NIL
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease
333166
0
Query!
Condition category
Condition code
Neurological
329862
329862
0
0
Query!
Parkinson's disease
Query!
Physical Medicine / Rehabilitation
330034
330034
0
0
Query!
Other physical medicine / rehabilitation
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
328165
0
Rehabilitation
Query!
Intervention code [2]
328272
0
Treatment: Other
Query!
Intervention code [3]
328273
0
Lifestyle
Query!
Comparator / control treatment
No control group
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
337638
0
Feasibility (safety)
Query!
Assessment method [1]
337638
0
Adverse event notification and recording by gym staff to share with research team, using adverse event documentation. Known/possible adverse events (1) fatigue; (2) muscle strain; (3) fall.
Query!
Timepoint [1]
337638
0
Baseline and daily (as required) over the course of the 8 week intervention program.
Query!
Primary outcome [2]
337793
0
Recruitment /retention of people with early onset Parkinson’s disease
Query!
Assessment method [2]
337793
0
Using audits of study enrolment/withdrawal logs, we will count of number of people referred, number of people eligible, number of people recruited and number of dropouts.
Query!
Timepoint [2]
337793
0
Baseline and daily (as required) over the course of the 8 week intervention program.
Query!
Primary outcome [3]
337794
0
Feasibility (access to physical infrastructure and resources )
Query!
Assessment method [3]
337794
0
Recording of cancelled sessions due to accessibility barriers including gym closure and unavailability of suitable equipment will be collected using stud-specific logbooks.
Query!
Timepoint [3]
337794
0
Baseline and daily (as required) over the course of the 8 week intervention program.
Query!
Secondary outcome [1]
432606
0
Disability
Query!
Assessment method [1]
432606
0
UPDRS- Section III Motor Examination
Query!
Timepoint [1]
432606
0
Baseline and 8 weeks after baseline
Query!
Secondary outcome [2]
432607
0
Quality of Life
Query!
Assessment method [2]
432607
0
SCOPA-PS
Query!
Timepoint [2]
432607
0
Baseline and 8 weeks after baseline
Query!
Secondary outcome [3]
432608
0
Health status
Query!
Assessment method [3]
432608
0
EQ5D VAS scale
Query!
Timepoint [3]
432608
0
Baseline and 8 weeks after baseline
Query!
Secondary outcome [4]
432609
0
Strength
Query!
Assessment method [4]
432609
0
Physiotherapist-led strength assessment procedure:
Participants self-select a load for 6-10 reps. Participants select attempt 1 weight based on warm-up and perform 3 repetitions. If 3RM not achieved on attempt 1, additional weight (5% for upper body, 10% for lower body) can be added on subsequent attempts. Process continued until accurate 3RM weight determined within 3-7 attempts.
Query!
Timepoint [4]
432609
0
Baseline and 8 weeks after baseline
Query!
Secondary outcome [5]
433339
0
PRIMARY OUTCOME: Feasibility (staffing)
Query!
Assessment method [5]
433339
0
Using study specific logbooks, we will count the number of staff approached, number of staff who complete education session, number of sessions supervised by each staff member
Query!
Timepoint [5]
433339
0
Baseline and daily (as required) over the course of the 8 week intervention program
Query!
Secondary outcome [6]
433340
0
PRIMARY OUTCOME: Feasibility (adherence to session program schedules)
Query!
Assessment method [6]
433340
0
Using study specific logbooks, we will record scheduled sessions and attendance
Query!
Timepoint [6]
433340
0
Baseline and daily (as required) over the course of the 8 week intervention program.
Query!
Secondary outcome [7]
433341
0
PRIMARY OUTCOME: Feasibility (cost of delivering powerlifting program)
Query!
Assessment method [7]
433341
0
Using study-specific logbooks, we will record the cost of exercise trainer wages, facility use, training the workforce and other relevant inputs
Query!
Timepoint [7]
433341
0
Baseline and daily (as required) over the course of the 8 week intervention program.
Query!
Secondary outcome [8]
433342
0
PRIMARY OUTCOME: Feasibility (participant perceptions on acceptability, benefits and limitations)
Query!
Assessment method [8]
433342
0
Semi-structured interviews will be conducted either 1:1 or in focus groups of up to 10 participants. These will be conducted by a member of the research team. Participants will be patients with Parkinsons disease or exercise trainers
Query!
Timepoint [8]
433342
0
Within one-week of each participants final assessment (8 weeks from baseline)
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
49
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
29/04/2024
Query!
Actual
5/06/2024
Query!
Date of last participant enrolment
Anticipated
30/12/2024
Query!
Actual
Query!
Date of last data collection
Anticipated
24/06/2025
Query!
Actual
Query!
Sample size
Target
10
Query!
Accrual to date
2
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Funding & Sponsors
Funding source category [1]
316031
0
Charities/Societies/Foundations
Query!
Name [1]
316031
0
Bethlehem Griffith Research Foundation
Query!
Address [1]
316031
0
Query!
Country [1]
316031
0
Australia
Query!
Primary sponsor type
University
Query!
Name
La Trobe University
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
318186
0
None
Query!
Name [1]
318186
0
Query!
Address [1]
318186
0
Query!
Country [1]
318186
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
314853
0
La Trobe University Human Ethics Committee
Query!
Ethics committee address [1]
314853
0
https://www.latrobe.edu.au/researchers/research-office/ethics/human-ethics
Query!
Ethics committee country [1]
314853
0
Australia
Query!
Date submitted for ethics approval [1]
314853
0
12/02/2024
Query!
Approval date [1]
314853
0
13/03/2024
Query!
Ethics approval number [1]
314853
0
HEC24036
Query!
Summary
Brief summary
The primary aim of this feasibility study is to assess the feasibility of a type of progressive resistance strength exercises for early onset Parkinson's disease, Modified Powerlifting will be conducted at a community gym for people with early onset PD. Adults under the age of 50 years who have a diagnosis of Parkinson's disease will be eligible to participate in an 8-week program, twice per week for up to 1 hour per session. We will measure the feasibility, including safety and adherence, as well as individual changes in disability, quality of life and strength over the course of the program.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
132934
0
Prof Meg Morris
Query!
Address
132934
0
La Trobe University, 1 Kingsbury Drive Bundoora VIC 3086
Query!
Country
132934
0
Australia
Query!
Phone
132934
0
+61433405662
Query!
Fax
132934
0
Query!
Email
132934
0
[email protected]
Query!
Contact person for public queries
Name
132935
0
Meg Morris
Query!
Address
132935
0
La Trobe University, 1 Kingsbury Drive Bundoora VIC 3086
Query!
Country
132935
0
Australia
Query!
Phone
132935
0
+61433405662
Query!
Fax
132935
0
Query!
Email
132935
0
[email protected]
Query!
Contact person for scientific queries
Name
132936
0
Meg Morris
Query!
Address
132936
0
La Trobe University, 1 Kingsbury Drive Bundoora VIC 3086
Query!
Country
132936
0
Australia
Query!
Phone
132936
0
+61433405662
Query!
Fax
132936
0
Query!
Email
132936
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
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.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
21835
Study 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.
Download to PDF