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Trial registered on ANZCTR


Registration number
ACTRN12617000503325
Ethics application status
Approved
Date submitted
30/03/2017
Date registered
6/04/2017
Date last updated
26/02/2020
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing models of physiotherapy service delivery in Parkinson's disease: A feasibility study
Scientific title
A randomised trial of the feasibility of two different models of physiotherapy service delivery for people with Parkinson's disease; predominantly group-based and predominantly home-based .
Secondary ID [1] 291222 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 302142 0
Condition category
Condition code
Neurological 301751 301751 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 301752 301752 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will complete a predominantly group-based physiotherapy exercise program conducted in conjunction with an exercise self-management program for the first 5 weeks of the intervention. Participants will perform physiotherapy exercises three times per week, with two group sessions (1 hour per session) and one home-based session (1 hour) each week. Exercises will be prescribed by a physiotherapist and will be based on each individual participant’s initial assessment results.

The group will have 5-8 participants per class, under the supervision of a physiotherapist and two physiotherapy students. The exercise program will consist of task-specific training of activities while targeting key motor impairments in PD (hypokinesia, bradykinesia, freezing of gait and postural instability). Examples of exercises include balance exercises (anticipatory and reactive), sit to stand, stepping and walking incorporating cueing and dual-task training strategies.

Participant’s home-based physiotherapy exercise programs will be prescribed by a physiotherapist and remotely monitored using internet and app resources available at PhysioTherapy eXercises. The home-based physiotherapy exercise program will be similar to the group-based program with adjustments made for safety and availability of equipment.

Participants will complete one weekly 15 minute self-management session, designed to increase self-efficacy for exercise and to promote the development of exercise self-management skills. The self-management program will be facilitated by a physiotherapist and consist of the following topics;
Why is exercise important (education session provided by the physiotherapist).
Goal setting (participants discuss how they like to exercise and set appropriate goals).
Identifying barriers to exercise (participants identify their barriers to exercises).
Solutions for barriers to exercise (participants provide solutions for each barrier identified).
Developing a plan to continue exercising (participants develop a five week plan to continue exercising).
Participants will be provided with worksheets to complete during the self-management sessions.

At the end of week 5, participants will be randomised to the predominantly home-based (PHB) or predominantly group-based (PGB) model.

Predominantly home-based physiotherapy
The PHB group will be prescribed, by a physiotherapist, a home-based physiotherapy exercise program to complete independently three times per week (1 hour per session) for 5 weeks (weeks 6 – 10). This program will be based on the group-based physiotherapy exercise program with adjustments made for safety and availability of equipment. Examples of exercises include balance exercises (anticipatory and reactive), sit to stand, stepping and walking incorporating cueing and dual-task training strategies.

These participants will receive two, five minute, phone calls (week 7 and week 9) from a physiotherapist. The purpose of the phone calls is to review participant’s performance, assist with any difficulties and progress the home exercise program (if indicated). The participant’s adherence and adverse events will be remotely monitored using internet and app resources available at PhysioTherapy eXercises. However, if participants prefer not to use the internet-based technology, adherence and adverse events will be monitored using paper-based log books.
Intervention code [1] 297294 0
Rehabilitation
Intervention code [2] 297703 0
Treatment: Other
Comparator / control treatment
Participants randomised to the PGB group will complete the same exercise and exercise self-management sessions as the PHB group for the first five weeks of intervention. Participants randomised to this group will continue to attend two group exercise classes per week (1 hour per session) and to perform the third exercise session independently at home (1 hour) for the remaining 5 weeks (weeks 6 – 10).

The group will have 5-8 participants per class, under the supervision of a physiotherapist and two physiotherapy students. The exercise program will consist of task-specific training of activities while targeting key motor impairments in PD (hypokinesia, bradykinesia, freezing of gait and postural instability). Examples of exercises include balance exercises (anticipatory and reactive), sit to stand, stepping and walking incorporating cueing and dual-task training strategies.

Participant’s home-based physiotherapy exercise programs will be prescribed by a physiotherapist and remotely monitored using internet and app resources available at PhysioTherapy eXercises. The home-based physiotherapy exercise program will be similar to the group-based program with adjustments made for safety and availability of equipment.
Control group
Active

Outcomes
Primary outcome [1] 301243 0
Feasibility of Recruitment, assessed by the evaluation of :
Number of participants screened
Number eligible for inclusion
Number who consent to participate
Timepoint [1] 301243 0
End of study
Primary outcome [2] 301244 0
Feasibility of the Intervention, assessed by the evaluation of:
Time taken to develop physiotherapy programs using PhysioTherpay eXercises.
Adherence of participants to the program including: number of sessions completed and number of exercises completed per session
Adverse events e.g number of falls and injuries sustained when performing exercises
Timepoint [2] 301244 0
After completion of the 10 week intervention
Secondary outcome [1] 332100 0
Balance assessed using the MiniBEST test
Timepoint [1] 332100 0
At base line and on completion of the 10 week intervention
Secondary outcome [2] 332101 0
Walking speed - 10m walk test
Timepoint [2] 332101 0
At base line and on completion of the 10 week intervention
Secondary outcome [3] 332105 0
Freezing of gait as assessed using the New Freezing of Gait Questionnaire
Timepoint [3] 332105 0
At base line and on completion of the 10 week intervention
Secondary outcome [4] 332106 0
Participants’ satisfaction with the delivery of the exercise program. This will be evaluated using a participant questionnaire specifically designed for this study.
Timepoint [4] 332106 0
At the end of week 5 and on completion of the 10 week intervention.
Secondary outcome [5] 347673 0
Participants’ experience of taking part in either a predominately group based or a predominately home based exercise program, and the acceptability of the programs.
Timepoint [5] 347673 0
On completion of the 10 week intervention

Eligibility
Key inclusion criteria
Idiopathic Parkinson's disease
Living in the community (Canberra and surrounding regions)
Stable medications for at least 2 weeks prior to baseline assessment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mini Mental State Examination of less than 24.
A medical condition which will prevent participants from completing a physiotherapy exercise program three times a week.
Are currently attending the PD exercise classes at the University of Canberra
Have attended the PD exercise classes at the University of Canberra in the last 12 weeks.

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)
People with PD who attend the University of Canberra clinic and people with PD who are members of Parkinson’s ACT will be informed about the study and if interested will be given a copy of the participant information sheet. Those who wish to participate will be screened and if eligible they will provide written informed consent prior to participation. Once enrolled in the trial a baseline assessment will be completed. After the baseline assessment all participants will complete a predominantly group-based program for the initial 5 weeks (two group sessions and one home-based session) in conjunction with an exercise self-management. During week 5 participants will be allocated randomly to either the PGB group or PHB group. Randomisation will be computer-generated. Random permuted blocks will be used so that both groups contain equal numbers. Randomisation will be centralized off-site, thereby concealing the sequence of group allocation from the researcher recruiting the participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number table will be generated using Excel
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
Feasibility will be determined using descriptive statistics.
The effectiveness of the intervention on walking speed and balance will be determined using analysis of co-variance, adjusted for baseline scores.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/04/2017
Actual
23/05/2017
Date of last participant enrolment
Anticipated
Actual
24/04/2019
Date of last data collection
Anticipated
10/07/2019
Actual
10/07/2019
Sample size
Target
40
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 295672 0
University
Name [1] 295672 0
University of Sydney
Country [1] 295672 0
Australia
Funding source category [2] 296120 0
University
Name [2] 296120 0
University of Canberrra
Country [2] 296120 0
Australia
Funding source category [3] 299972 0
Charities/Societies/Foundations
Name [3] 299972 0
Parkinson's ACT
Country [3] 299972 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 294518 0
None
Name [1] 294518 0
Address [1] 294518 0
Country [1] 294518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296986 0
The University of Canberra Human Research Ethics Commitee
Ethics committee address [1] 296986 0
Ethics committee country [1] 296986 0
Australia
Date submitted for ethics approval [1] 296986 0
Approval date [1] 296986 0
20/09/2016
Ethics approval number [1] 296986 0
16-153

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

Contacts
Principal investigator
Name 72630 0
Prof Colleen Canning
Address 72630 0
The University of Sydney
Faculty of Health Sciences
PO Box 170
Lidcombe, NSW 1825
Country 72630 0
Australia
Phone 72630 0
+61 2 9351 9263
Fax 72630 0
Email 72630 0
Colleen.Canning@sydney.edu.au
Contact person for public queries
Name 72631 0
Allyson Flynn
Address 72631 0
Faculty of Health Clinics
University of Canberra
Building 28, Level C
Cnr Ginninderra Drive and Allawoona St
BRUCE ACT 2617
Country 72631 0
Australia
Phone 72631 0
+61 2 6206 8850
Fax 72631 0
Email 72631 0
Allyson.Flynn@Canberra.edu.au
Contact person for scientific queries
Name 72632 0
Allyson Flynn
Address 72632 0
Faculty of Health Clinics
University of Canberra
Building 28, Level C
Cnr Ginninderra Drive and Allawoona St
BRUCE ACT 2617
Country 72632 0
Australia
Phone 72632 0
+61 2 6206 8850
Fax 72632 0
Email 72632 0
Allyson.Flynn@Canberra.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.