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Trial registered on ANZCTR


Registration number
ACTRN12617001057370
Ethics application status
Approved
Date submitted
17/07/2017
Date registered
19/07/2017
Date last updated
9/11/2022
Date data sharing statement initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a physiotherapy exercise program with a self-management approach v's usual care on physical activity in people with mild-moderate Parkinson’s disease: A Randomised Controlled Trial
Scientific title
The effect of a physiotherapy exercise program with a self-management approach v's usual care on physical activity in people with mild-moderate Parkinson’s disease: A Randomised Controlled Trial
Secondary ID [1] 292362 0
Nil known
Universal Trial Number (UTN)
U1111-1199-3683
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 303908 0
Condition category
Condition code
Neurological 303272 303272 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Group Exercise - Twelve, physiotherapy supervised, small group (3-4 participants) structured exercise sessions over 4 weeks, each 75-80 minutes duration. Each exercise session will include a short group warm up followed by a structured circuit of:
- 30 minutes of treadmill walking conducted at an intensity of 60-80% of heart rate reserve
- Lower limb progressive resistance training targeting hip flexors and extensors and abductors, knee extensors and ankle plantarflexors. Three sets of 8-10 repetitions of each exercise will be performed at 60-80% of the participants one repeat maximum (1RM), with resistance increased by five percent when participants are able to achieve 10 repetitions in their third set at 80% of their 1RM. After the first week of training, participants who demonstrate good technique of strength training exercises will incorporate power training sets 1-2 per session at 40-60% 1RM.
- Balance and gait retraining exercises will be prescribed as needed for each individual incorporating the principles of movement strategy training and highly challenging balance retraining including exercises such as walking with variable speed and focus on big steps with and without gait obstacles.
Each exercise session will end with a group cool down session. 

2. Chronic Disease Self-Management (CDSM) – Will be delivered during the same 4-week period that participants are participating in the exercise groups. This will involve 5-10 minute sessions, delivered individually to the participants by the physiotherapists prior to or during the exercise sessions. Participants will be taught behaviour change techniques such as goal setting and action planning to encourage initiation and maintenance of physical activity. At the first exercise session, participants in the intervention group will receive information and a workbook to encourage self-monitoring of physical activity and guide participants through the process of setting short- and long-term goals as well as formulating action plans and coping strategies. During the 4 weeks of exercise sessions and the following 6 months, participants will also be provided with a Garmin Vivosmart armband that monitors and sets goals for physical activity (number of steps / day), and records heart rate, and distance travelled. Physiotherapists will contact participants monthly in the six months following the exercise intervention to discuss their physical activity goals and achievements.
3. Usual care – Participants in the intervention group will continue with their usual Parkinson's disease management. Content, volume and intensity of usual care will be monitored weekly over the 4-weeks following baseline assessment using questionnaires and patient interview.
Group exercise and CDSM will be prescribed and supervised by a registered and physiotherapist with experience in the management of Parkinson’s disease within a physiotherapy rehabilitation gym of a local metropolitan hospital or University clinic.
Usual care will continue to be provided by the participants' chosen health professionals within their chosen environment. The content of usual care will be recorded by the research staff, but will not be influenced by the research staff.
Intervention code [1] 298534 0
Rehabilitation
Intervention code [2] 298535 0
Behaviour
Comparator / control treatment
Participants allocated to the control group will continue with their usual Parkinson's disease management. Content, volume and intensity of usual care will be monitored weekly over the 4-weeks following baseline assessment using questionnaires and patient interview. Usual care will continue to be provided by the participants' chosen health professionals within their chosen environment. The content of usual care will be recorded by the research staff, but will not be influenced by the research staff.
Control group
Active

Outcomes
Primary outcome [1] 302650 0
Free-living physical activity: average number of steps/day over 7-days as measured with the ActivPALTM accelerometer
Timepoint [1] 302650 0
Baseline (week 0) and the week following conclusion of the 12th exercise session (week 4).
Secondary outcome [1] 336654 0
Free-living physical activity: average number of steps/day over 7-days as measured with the ActivPALTM accelerometer
Timepoint [1] 336654 0
Baseline (week 0), follow-up 6 months post intervention (week 26)
Secondary outcome [2] 336655 0
Free-living physical activity - average daily time spent walking, measured with ActivPALTM accelerometer.
Timepoint [2] 336655 0
Baseline (week 0), in the week following conclusion of the 12th exercise session (week 4), follow-up 6 months post intervention (week 26)
Secondary outcome [3] 336656 0
Free-living physical activity - average daily time spent sedentary measured with ActivPALTM accelerometer.
Timepoint [3] 336656 0
Baseline (week 0), the week following conclusion of the 12th exercise session (week 4), follow-up 6 months post intervention (week 26)
Secondary outcome [4] 336657 0
Free-living physical activity - total minutes/week spent in moderate intensity exercise measured with ActivPALTM accelerometer and Multimedia Activity Recall for Children and Adults (MARCA).
Timepoint [4] 336657 0
Baseline (week 0), in the week following conclusion of the 12th exercise session (week 4), follow-up 6 months post intervention (week 26)
Secondary outcome [5] 336659 0
Step length during single task walking over 8 meters measured using a GAITrite electronic walkway
Timepoint [5] 336659 0
Baseline (week 0), in the week following conclusion of the 12th exercise session (week 4), follow-up 6 months post intervention (week 26)
Secondary outcome [6] 336978 0
Gait speed during single task walking over 8 meters measured using a GAITrite electronic walkway
Timepoint [6] 336978 0
Baseline (week 0), in the week following conclusion of the 12 exercise sessions (week 4), follow-up 6 month post intervention (week 26)
Secondary outcome [7] 337014 0
Step length during dual task walking over 8 meters measured using a GAITrite electronic walkway
Timepoint [7] 337014 0
Baseline (week 0), in the week following conclusion of the 12 exercise sessions (week 4), follow-up 6 month post intervention (week 26)
Secondary outcome [8] 337016 0
Gait speed during dual task walking over 8 meters measured using a GAITrite electronic walkway
Timepoint [8] 337016 0
Baseline (week 0), in the week following conclusion of the 12 exercise sessions (week 4), follow-up 6 month post intervention (week 26)
Secondary outcome [9] 337018 0
The proportion of people meeting American College of Sports Medicine physical activity guidelines with respect to volume of physical activity will also be calculated using the Multimedia Activity Recall for Children and Adults (MARCA).
Timepoint [9] 337018 0
Baseline (week 0), in the week following conclusion of the 12 exercise sessions (week 4), follow-up 6 month post intervention (week 26)
Secondary outcome [10] 337019 0
Gait endurance will be measured using the 6 minute walk test
Timepoint [10] 337019 0
Baseline (week 0), in the week following conclusion of the 12 exercise sessions (week 4), follow-up 6 month post intervention (week 26)
Secondary outcome [11] 337020 0
Health-related quality of life will be measured using the 39 item-Parkinson’s disease questionnaire - PDQ-39
Timepoint [11] 337020 0
Baseline (week 0), in the week following conclusion of the 12 exercise sessions (week 4), follow-up 6 month post intervention (week 26)
Secondary outcome [12] 337034 0
Outcome expectations for Exercise will be measured using the Outcome Expectations for Exercise (OEE) Scale
Timepoint [12] 337034 0
Baseline (week 0), in the week following conclusion of the 12 exercise sessions (week 4), follow-up 6 month post intervention (week 26)
Secondary outcome [13] 337036 0
Self-efficacy for exercise will be measured using the Self-efficacy for Exercise Scale
Timepoint [13] 337036 0
Baseline (week 0), in the week following conclusion of the 12 exercise sessions (week 4), follow-up 6 month post intervention (week 26)

Eligibility
Key inclusion criteria
Diagnosis of idiopathic PD confirmed by a neurologist
Modified Hoehn & Yahr stage I to III
Living in the community
Able to attend assessment and treatment sessions
Montreal Cognitive Assessment Scale (MoCA) score of >23/30
Provide consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who have had surgical management of their PD
Other neurological disorders, uncorrected sensory deficits, or medical conditions that may limit their ability to safely exercise
People who report that they are already meeting physical activity guidelines for older adults (exercising for >150 minutes/week at a moderate intensity)

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)
Potential participants will be notified of the study commencement via neurologists and allied health rehabilitation units in the Brisbane metropolitan area and calls for participants circulated to past research participants and support group organisations. Interested volunteers will contact the researchers, and telephone screening will be undertaken to determine if they meet inclusion criteria. Suitable participants will attend the baseline assessment where suitability will be confirmed and baseline data collected. Following baseline assessment consecutively numbered, randomly ordered opaque envelopes containing group allocation will be opened by the therapist implementing the intervention, to reveal the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed offsite by a person independent to the study. Computerised random numbers will be generated in variable block permutations of 4 or 6.
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
A sample of 92 participants (46/group) will be recruited to show a change of 22% between the two groups in number of steps/day at the post intervention (4 weeks) time point. This calculation was based on previous studies of people with mild-mod PD who volunteered for exercise trials (3900 to 5000 steps SD 2000; Benka Wallen et al, 2015) that resulted in a sample size of 41 people/group, with an allowance for dropouts of 12% resulting in a planned sample size of 46 people/group.

All analyses will be performed on an intention to treat basis. To determine if there are differences between groups in physical activity outcomes post intervention, linear mixed models will be performed investigating group (intervention vs. control), time (baseline, post, follow-up) and group x time interactions for all variables. Baseline characteristics will be compared between groups and any differences included as covariates. Post hoc univariate testing will be undertaken if main effects and interactions are significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2017
Actual
29/01/2018
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
92
Accrual to date
85
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 296914 0
Other
Name [1] 296914 0
Wesley Medical Research
Country [1] 296914 0
Australia
Primary sponsor type
Individual
Name
Sandra Brauer
Address
School of Health & Rehabilitation Sciences, The University of Queensland, Brisbane, Qld, 4072.
Country
Australia
Secondary sponsor category [1] 295918 0
Individual
Name [1] 295918 0
Robyn Lamont
Address [1] 295918 0
School of Health & Rehabilitation Sciences, The University of Queensland, Brisbane, Qld, 4072.
Country [1] 295918 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298124 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 298124 0
Ethics committee country [1] 298124 0
Australia
Date submitted for ethics approval [1] 298124 0
20/10/2016
Approval date [1] 298124 0
09/12/2016
Ethics approval number [1] 298124 0
1628
Ethics committee name [2] 298125 0
The University of Queensland Human Ethics Research Committee
Ethics committee address [2] 298125 0
Ethics committee country [2] 298125 0
Australia
Date submitted for ethics approval [2] 298125 0
18/01/2017
Approval date [2] 298125 0
20/02/2017
Ethics approval number [2] 298125 0
2017000068 / 1628
Ethics committee name [3] 307929 0
Metro South Health Service Human Research Ethics Committee - EC00167
Ethics committee address [3] 307929 0
Ethics committee country [3] 307929 0
Australia
Date submitted for ethics approval [3] 307929 0
16/05/2019
Approval date [3] 307929 0
03/09/2019
Ethics approval number [3] 307929 0
HREC/2019/QMS/50091

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

Contacts
Principal investigator
Name 76078 0
Prof Sandra Brauer
Address 76078 0
Division of Physiotherapy School of Health & Rehabilitation Sciences The University of Queensland St Lucia, Qld, 4072
Country 76078 0
Australia
Phone 76078 0
+61 7 3365 2317
Fax 76078 0
+61 7 3365 1622
Email 76078 0
s.brauer@uq.edu.au
Contact person for public queries
Name 76079 0
Robyn Lamont
Address 76079 0
Division of Physiotherapy School of Health & Rehabilitation Sciences The University of Queensland St Lucia, Qld, 4072
Country 76079 0
Australia
Phone 76079 0
+61 7 3365 2779
Fax 76079 0
+61 7 3365 1622
Email 76079 0
r.lamont@uq.edu.au
Contact person for scientific queries
Name 76080 0
Sandra Brauer
Address 76080 0
Division of Physiotherapy School of Health & Rehabilitation Sciences The University of Queensland St Lucia, Qld, 4072
Country 76080 0
Australia
Phone 76080 0
+61 7 3365 2317
Fax 76080 0
+61 7 3365 1622
Email 76080 0
s.brauer@uq.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?
Only de-identified individual participant data that under pins the published results will be made available.
When will data be available (start and end dates)?
Immediately following publication with no end date.
Available to whom?
Data will be available on a case-by-case basis at the discretion of Primary Sponsor and only to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Potentially for any secondary analysis deemed suitable and sound by the sponsor including but not limited to meta analyses.
How or where can data be obtained?
Access will be subject to approvals by the Principle investigator therefore data will be obtainable by contacting the corresponding author.


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
SourceTitleYear of PublicationDOI
EmbasePhysical exercise for people with Parkinson's disease: a systematic review and network meta-analysis.2023https://dx.doi.org/10.1002/14651858.CD013856.pub2
EmbaseA physiotherapy group exercise and self-management approach to improve physical activity in people with mild-moderate Parkinson's disease: a randomized controlled trial.2024https://dx.doi.org/10.1186/s13063-023-07870-4
N.B. These documents automatically identified may not have been verified by the study sponsor.