Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000501448p
Ethics application status
Submitted, not yet approved
Date submitted
13/05/2025
Date registered
22/05/2025
Date last updated
22/05/2025
Date data sharing statement initially provided
22/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of Gym Exercises on Wellbeing in Women Living with Parkinson's Disease
Scientific title
Feasibility of Exercise for Women Living with Parkinson's Disease
Secondary ID [1] 314438 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 337467 0
Condition category
Condition code
Physical Medicine / Rehabilitation 333840 333840 0 0
Physiotherapy
Neurological 333839 333839 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Strength and fitness exercise sessions will be delivered to women diagnosed with idiopathic Parkinson's disease, twice-weekly in a gym setting. Exercise sessions will be supervised one-to-one by exercise trainers employed at the gym. All exercise trainers will have completed an education and training program developed and delivered by physiotherapists with expertise in neurological rehabilitation. The exercise sessions will run for up to one hour each time. Participants will be scheduled to attend 16 exercise sessions over eight consecutive weeks. Participants will be monitored for safety and exercise tolerance by the trainers. The exercise trainers will be educated to seek feedback on exercise intensity from participants by using Rate of Perceived Exertion (RPE), and advised not to exceed a moderate level of intensity. Attendance at scheduled sessions and adherence to exercise programs will be recorded by the exercise trainers. Physiotherapists will be in attendance at the initial two sessions, then will continue to provide oversight and supervision of the program delivery through regular communication with the exercise trainers. Exercise trainers will follow an exercise program guide that includes a broad range of options allowing for individualization dependent on participant ability. Trainers will modify exercise selection based on their own observations of the participant, feedback from the participant, and input from the research physiotherapists when required. This will happen dynamically throughout the program. All programs follow the same four phases: (i) an aerobic exercise warm up using either a stationary bike, rower machine or arm ergo machine; (ii) a selection of large muscle group stretching and core/trunk muscle strengthening exercises; (iii) progressive functional muscle group strengthening exercises using bands, fixed machine weights or free weights (where able); (iv) cool down with stretching/relaxation exercises.
Intervention code [1] 331061 0
Lifestyle
Intervention code [2] 331060 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341451 0
Feasibility (attendance)
Timepoint [1] 341451 0
Daily (as required) over the eight-week intervention schedule
Primary outcome [2] 341450 0
Feasibility (safety)
Timepoint [2] 341450 0
Daily (as required) over the 8 weeks of intervention
Primary outcome [3] 341452 0
Feasibility (adherence)
Timepoint [3] 341452 0
Daily as required over the eight-week intervention
Secondary outcome [1] 447549 0
Fatigue
Timepoint [1] 447549 0
Baseline and eight-weeks after baseline (session 16)
Secondary outcome [2] 447567 0
Feasibility (cost of delivering the exercise programs)
Timepoint [2] 447567 0
Daily (as required) over the eight week intervention
Secondary outcome [3] 447548 0
Heat sensitivity
Timepoint [3] 447548 0
Baseline and eight-weeks after baseline (session 16)
Secondary outcome [4] 447565 0
PRIMARY OUTCOME: Feasibility (participant perceptions of acceptability, benefits and limitations)
Timepoint [4] 447565 0
Within one-week of final assessment (session 16)
Secondary outcome [5] 447562 0
Muscle strength
Timepoint [5] 447562 0
Baseline and eight weeks after baseline (session 16)
Secondary outcome [6] 447552 0
Parkinson's disease non-motor symptoms
Timepoint [6] 447552 0
Baseline and eight-weeks after baseline (session 16)
Secondary outcome [7] 447568 0
Wellbeing
Timepoint [7] 447568 0
Within one week of each participant's final session
Secondary outcome [8] 447546 0
Disability
Timepoint [8] 447546 0
Baseline and eight-weeks after baseline (session 16)
Secondary outcome [9] 447553 0
Quality of life
Timepoint [9] 447553 0
Baseline and eight-weeks after baseline (session 16)
Secondary outcome [10] 447547 0
Health Related Quality of life
Timepoint [10] 447547 0
Baseline and eight-weeks after baseline (session 16)
Secondary outcome [11] 447566 0
Staffing
Timepoint [11] 447566 0
Daily (as required) over the eight week intervention

Eligibility
Key inclusion criteria
Participants will be women diagnosed with idiopathic Parkinson's disease; able to provide written informed consent; able to attend a participating gym in Australia for exercise; proficient in English language; willing to obtain a medical clearance to exercise from a medical practitioner.
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are male or if they have other neurological disorders, comorbidities or injuries impacting mobility or impeding safe exercise, severe auditory or visual impairment, uncontrolled cardiac or lung conditions, musculoskeletal conditions (e.g., back pain or arthritis), uncontrolled diabetes, mood disorders, cognitive impairment, unmanaged medical or surgical conditions, cancer, obesity, or using Parkinson’s medication pumps. or currently receiving deep brain stimulation.

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 women with idiopathic Parkinson's disease and all will be offered training twice per week for 8 consecutive weeks in a gym.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
27/10/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318968 0
Charities/Societies/Foundations
Name [1] 318968 0
Fight Parkinson's
Country [1] 318968 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 321441 0
None
Name [1] 321441 0
Address [1] 321441 0
Country [1] 321441 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317576 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 317576 0
Ethics committee country [1] 317576 0
Australia
Date submitted for ethics approval [1] 317576 0
22/05/2025
Approval date [1] 317576 0
Ethics approval number [1] 317576 0

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

Contacts
Principal investigator
Name 141482 0
Prof Meg Morris
Address 141482 0
La Trobe University, 1 Kingsbury Drive, Bundoora VIC 3086
Country 141482 0
Australia
Phone 141482 0
+61 433405662
Fax 141482 0
Email 141482 0
[email protected]
Contact person for public queries
Name 141483 0
Meg Morris
Address 141483 0
La Trobe University, 1 Kingsbury Drive, Bundoora VIC 3086
Country 141483 0
Australia
Phone 141483 0
+61 433405662
Fax 141483 0
Email 141483 0
[email protected]
Contact person for scientific queries
Name 141484 0
Meg Morris
Address 141484 0
La Trobe University, 1 Kingsbury Drive, Bundoora VIC 3086
Country 141484 0
Australia
Phone 141484 0
+61 433405662
Fax 141484 0
Email 141484 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Because there are only 10 people with a rare condition individual data sharing beyond the investigators could put them at risk of identification. It is essential to maintain confidentiality.



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.