Currently submitted to: JMIR Research Protocols
Date Submitted: Sep 8, 2026
Open Peer Review Period: Sep 9, 2026 - Nov 4, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Safety, Feasibility And Tolerance Of Community Gym Exercise Therapy For Women With Parkinson's Disease: Protocol For A Phase I Trial
ABSTRACT
Background:
Women living with PD are often advised to exercise yet the extent to which exercise therapy is safe and feasible for these women remains unclear. Despite growing evidence supporting exercise therapy in mixed-gender cohorts, its effects on motor and non-motor symptom burden, disability, muscle strength, and quality of life in women living with PD are largely unknown.
Objective:
Evaluate the safety, feasibility, tolerance, acceptability, and preliminary effects of exercise therapy in community gym on health outcomes in women living with PD.
Methods:
Phase I trial of exercise therapy in a community gym for women with lived experience of idiopathic PD. Women with PD will participate in an individualized, physiotherapist-designed community gym-based exercise therapy program. Sixteen sessions will be delivered twice weekly over eight weeks for up to 60 minutes per session. Physiotherapists with PD expertise will educate exercise trainers who will provide 1:1 supervision of the gym sessions. The primary outcome of safety will be evaluated through adverse event monitoring and participant reported experiences of safety. Secondary outcomes include intervention feasibility, as well as changes in disability, strength, mobility, non-motor symptom burden and quality of life. Feasibility will be evaluated by analyzing recruitment and retention, intervention tolerance and acceptability. Qualitative data will be collected from women with PD and trainers at the end of the gym program using semi-structured interviews. It will be analyzed thematically to explore participant views of program tolerance, including acceptability, value and challenges.
Results:
The trial was funded in July 2025. Data collection commenced in September 2025. The results are expected to be published in February 2027.
Conclusions:
This Phase I trial will address a gap in understanding the safety, feasibility, and preliminary effects on health outcomes of gym-based exercise therapy tailored to the needs of women with Parkinson's disease. Clinical Trial: This trial was prospectively registered with the Australia and New Zealand Clinical Trial Registry (ANZCTR) ACTRN12625000501448p.
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