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Trial registered on ANZCTR


Registration number
ACTRN12620001135909
Ethics application status
Approved
Date submitted
21/08/2020
Date registered
30/10/2020
Date last updated
30/10/2020
Date data sharing statement initially provided
30/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Trial of Exercise Therapy for Parkinson’s Disease
Scientific title
A Randomised Controlled Trial (RCT) to investigate the effect of Exercise Therapy on mobility and disability in people with Parkinson’s disease
Secondary ID [1] 301617 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson’s disease 318625 0
Condition category
Condition code
Neurological 316643 316643 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 317064 317064 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.


Intervention code [1] 318336 0
Rehabilitation
Intervention code [2] 318628 0
Treatment: Other
Comparator / control treatment
Participants randomly allocated into the active control group will do stretching, flexibility exercises, and relaxation exercises (e.g. one minute of relaxation, with focus on the breath) at home for 1 hour 2 times per week for 3 months. Participants in active control group will also be provided with falls education, consisting of reading material (a pamphlet designed specifically for this study).
There will be an initial training session (approx 45 mins) at the Interprofessional Clinic at James Cook University with a physiotherapist or exercise physiologist to ensure the home exercises are being performed correctly. The physiotherapist will get each participant to perform each exercise individually and gone through the description of all exercises to ensure participants understand how to perform them. Participants will also be made aware that they can contact a nominated registered therapist at anytime if the have any questions.
There will be weekly mini surveys, use of physitrack app, and weekly fidelity checks by a registered physiotherapist There will be weekly mini surveys, use of physitrack app, and weekly fidelity checks by a registered physiotherapist to ensure adherence to active control protocol.
Control group
Active

Outcomes
Primary outcome [1] 324767 0
The primary outcome will be the between-group difference in mobility as measured by the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) motor section at 3 month post-intervention completion, tested during the “on” phase of the levodopa cycle.
Timepoint [1] 324767 0
3 month post-intervention completion
Secondary outcome [1] 385709 0
6m walk test (On-stage gait speed, on-stage gait speed, and walking function)
Timepoint [1] 385709 0
3 month post-intervention completion
Secondary outcome [2] 387044 0
6-minute walk test (walking function)
Timepoint [2] 387044 0
3 month post-completion follow up
Secondary outcome [3] 387045 0
MDS-UPDRS (degree of disability)
Timepoint [3] 387045 0
3 month post-intervention completion
Secondary outcome [4] 387046 0
PDQ39 (on-stage quality of life; see van Uem 2014)
Timepoint [4] 387046 0
3 month post intervention follow up
Secondary outcome [5] 387047 0
reported falls (measured using a falls diary as per Morris et al. 2015, 2017)
Timepoint [5] 387047 0
3 month post intervention follow up

Eligibility
Key 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
Minimum age
30 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants shall be randomly allocated to groups by means of a computerized sequence (block randomization) controlled by an independent statistician not involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerized sequence (block randomization)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Summary data for all dependent variables will be summarised by group (means, medians, range, variability). We shall use a series of t tests and analysis of covariance (ANCOVA) to analyse the results. All analyses will be conducted on an intention-treat basis. In case of missing data, sensitivity analysis (last observation carried forward) will be used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 306048 0
University
Name [1] 306048 0
La Trobe University
Address [1] 306048 0
Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country [1] 306048 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 306510 0
University
Name [1] 306510 0
James Cook University
Address [1] 306510 0
1 James Cook Dr, Douglas QLD 4811
Country [1] 306510 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306275 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 306275 0
La Trobe University, Melbourne Campus, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Ethics committee country [1] 306275 0
Australia
Date submitted for ethics approval [1] 306275 0
11/03/2020
Approval date [1] 306275 0
14/07/2020
Ethics approval number [1] 306275 0
HEC20108

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103330 0
Prof Meg Morris
Address 103330 0
SHE College La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora 3086 Victoria Australia
Country 103330 0
Australia
Phone 103330 0
+61 433405662
Fax 103330 0
Email 103330 0
m.morris@latrobe.edu.au
Contact person for public queries
Name 103331 0
Prof Meg Morris
Address 103331 0
SHE College La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora 3086 Victoria Australia
Country 103331 0
Australia
Phone 103331 0
+61 433405662
Fax 103331 0
Email 103331 0
m.morris@latrobe.edu.au
Contact person for scientific queries
Name 103332 0
Prof Meg Morris
Address 103332 0
SHE College La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora 3086 Victoria Australia
Country 103332 0
Australia
Phone 103332 0
+61 433405662
Fax 103332 0
Email 103332 0
m.morris@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data on UPDRS, PDQ-39, and gait speed
When will data be available (start and end dates)?
After completion of data analysis (available from Dec, 2021), there is no end date
Available to whom?
De-identified data will be publicly available
Available for what types of analyses?
Analysis of de-identified data
How or where can data be obtained?
La Trobe University Research Repository by emailing the principal investigator: M.Morris@latrobe.edu.au
What supporting documents are/will be available?
Clinical study report
How or where can supporting documents be obtained?
Type [1] 8893 0
Clinical study report
Citation [1] 8893 0
Link [1] 8893 0
Email [1] 8893 0
m.morris@latrobe.edu.au
Other [1] 8893 0
Please contact Prof Meg Morris
Attachment [1] 8893 0
Summary results
No Results