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A Randomised Trial of Exercise Therapy for Parkinson’s Disease

A Randomised Controlled Trial (RCT) to investigate the effect of Exercise Therapy on mobility and disability in people with Parkinson’s disease

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001135909
Enrollment
10
Registered
2020-10-30
Start date
2020-09-11
Completion date
2022-12-05
Last updated
2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To our knowledge, there has never been published a controlled trial on exercise for PD in a tropical climate, despite regional areas such as Townsville having a high incidence of PD. This phase I trial will add new data on that topic. Our previous clinical trials (Morris et al 2009;2015) showed that hospital-based and outpatient clinic-based physiotherapy were effective for improving mobility and reducing falls in people living with Parkinson’s disease. These trials were conducted in a temperate climate (Melbourne). There is a need understand responses of PD patients in tropical climates (such as Townsville) to structured exercises programs and to determine whether outpatient physiotherapy that comprises general fitness aerobic exercises plus balance training (45 minutes) and falls education (15 minutes) twice a week for 3 months in a gymnasium setting is more effective than home-based exercises coupled with falls education. It is possible that the exercise classes could reduce disability and improve mobility in Parkinsonism.

Interventions

Participants will be randomly allocated to an experimental group that attends the Interprofessional Clinic in the Clinical Practice Building at James Cook University, Townsville for 1 hour 2 times per week for 3 months. The experimental group exercises will include strength training, treadmill training, exercises, walking, bicycle training, skipping, and other aerobic exercises, sometimes with music, at a moderate intensity for up to 60 minutes including warm up and cool down, plus balance train

Participants will be randomly allocated to an experimental group that attends the Interprofessional Clinic in the Clinical Practice Building at James Cook University, Townsville for 1 hour 2 times per week for 3 months. The experimental group exercises will include strength training, treadmill training, exercises, walking, bicycle training, skipping, and other aerobic exercises, sometimes with music, at a moderate intensity for up to 60 minutes including warm up and cool down, plus balance training and falls education (15 minutes) 2 days per week for 3 months. These exercises will be guided by a physiotherapist or exercise physiologist. In the experimental condition, level of intensity will be assessed using Borg Rating of Perceived Exertion Scale (RPE; Borg 1982). Participants will be asked how hard they have worked during the class using a numbered scale (6-20 RPE) with brief descriptions. We will ask participants to exercise at a moderate intensity which is indicated by a score of 12-13 points on the Borg RPE scale. The balance exercises will challenge participants’ stability in standing by asking them to perform tasks that decrease their base of support, increase their movement of the center of mass and minimize the use of upper limbs for balance. Falls education will be integrated with balance exercise instructions for experimental group; and will consist of reading material (a pamphlet designed specifically for this study) for the active control group. There will be weekly fidelity checks for both experimental and active control groups; including mini-surveys for experimental group instructor, and all participants. For the active control the physitrack application and weekly follow ups with a registered physiotherapist will also be used to monitor adherence to protocol.

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

a. Parkinson’s disease b. Modified Hoehn & Yahr stage 3 or less when tested ON. c. Age 30-75 years d. Sedentary lifestyle (low levels of aerobic physical activity, defined by the American College of Sports Medicine recommendation for older adults as just any level below recommended weekly amount of aerobic exercise). e. Receiving a stable dopaminergic medication dose (levodopa and/or a dopamine agonist) for at least one month before the study, or else De-novo – not receiving PD medication

Exclusion criteria

a) Judged unsafe to exercise by medical practitioner b) Currently using beta-blockers c) Currently using anti-psychotics d) Unable to cycle, use a treadmill or perform stretching exercises due to neurological conditions or co-morbidities e) Unable to fill out questionnaires due to poor vision or other reasons f) Unable to independently transport self to the exercise venue g) Unable to read h) Psychiatric conditions or major depression i) Mini Mental Status Examination (MMSE) score of less than 24 j) Contra-indications to aerobic exercise, such as diagnosed cardiac diseases (eg. unstable angina, heart block, arrhythmia’s, uncontrolled hypertension), poorly controlled diabetes

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026