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Trial registered on ANZCTR


Registration number
ACTRN12619000415101
Ethics application status
Approved
Date submitted
11/03/2019
Date registered
13/03/2019
Date last updated
13/03/2019
Date data sharing statement initially provided
13/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Integrate program for safe mobility in Parkinson's Disease.
Scientific title
Integrate: a randomised controlled trial of a tailored and multi factorial program for safe mobility in people with Parkinson's Disease.
Secondary ID [1] 297294 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 311377 0
mobility 311378 0
Condition category
Condition code
Neurological 310015 310015 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 310016 310016 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a 6 month multi factorial home-based program (ie. multiple interventions tailored to the individual and targeting their mobility related goals) designed to improve for safe mobility and reduce falls in people with Parkinson's Disease. Participants will undertake the intervention in addition to their usual care. The intervention will consist of environmental modification, behavioral modification and exercise which will be delivered to participants in their homes by trained occupational therapists and physiotherapists. Participants will receive 8-12 therapy home visits over a 6 month period depending on their need. The components of the program will be designed in collaboration with the person with PD and any care partner. The ratio of physiotherapy and occupational therapy home visits will depend on each participants physical abilities, functional cognition, ability to engage with the different components of the intervention, identified goals and issues of safety. Participants will receive regular phone calls (at least 5 phone calls during the intervention period) to monitor progress and address any problems arising related to the intervention.
The environmental and behavioural components of the program will be delivered as a home and community safety package. Strategies will be discussed with the participant (and any care partner) and implemented through the use of diaries and goal setting. Environmental adaptations to reduce falls risk will be introduced (eg. removal of clutter,improving lighting) and participants who display unsafe patterns of movement will be taught how to use cues and strategies to initiate and maintain safe movement. Situational cues will be used as prompts to reinforce goal directed behavior. Participants will be provided with a home safety booklet which will be adapted to their cognitive abilities and will outline recommendations. The booklets will be designed by the research team specifically for this trial.

The home based exercise component of the program will be individually prescribed and delivered to participants in their homes by an experienced Physiotherapist and will include commonly used exercises for fall prevention (www.webb.org.au) and PD specific exercises available at www.physiotherapyexercises.com. These exercises are known remedial risk factors for falls in people with PD (ie. leg muscle weakness, poor standing balance and freezing of gait). Exercises will be prescribed to be performed in 30 minute sessions, between 3-5 times per week. In order to maximize efficiency and minimize adverse events, programs will be individually prescribed and progressed according to participants physical and cognitive abilities. Participants will be shown how to exercise with a stable support nearby if necessary.
Exercises will also be taught to any care partner who will provide supervision and assistance (including appropriate cueing) as required. Participants and any care partner will be provided with an exercise booklet, designed by research staff specifically for the trial, which will include clear pictorial and simple written instructions, as well as precautions and instructions to advise study staff and /or their medical practitioner if they experience any major adverse effects from the exercise. They will also be provided with a log book to record completed exercises and any effects of the exercise (eg. muscle soreness).
Intervention code [1] 313549 0
Treatment: Other
Intervention code [2] 313550 0
Rehabilitation
Intervention code [3] 313551 0
Behaviour
Comparator / control treatment
Usual care control group. The control group will continue to receive their usual treatment for their Parkinson's disease and will continue with their usual daily activities.
Control group
Active

Outcomes
Primary outcome [1] 318925 0
Short Physical Performance Battery index score

Timepoint [1] 318925 0
Within two weeks before the intervention and immediately after the intervention period
Primary outcome [2] 318945 0
Goal Attainment Scale
Timepoint [2] 318945 0
Goal(s) set within 2 weeks prior to intervention, and goal attainment assessed immediately after the intervention period
Secondary outcome [1] 366433 0
Standing balance item from the Short Physical Performance Battery (ability to stand feet together, semi-tandem or tandem for 10 seconds)
Timepoint [1] 366433 0
Within two weeks before the intervention and immediately after the intervention period
Secondary outcome [2] 366434 0
Walking speed item from the Short Physical Performance Battery - walking at usual speed over 4 m,
Timepoint [2] 366434 0
Within two weeks before the intervention and immediately after the intervention period
Secondary outcome [3] 366435 0
Sit to stand speed item from the Short Physical Performance Battery - time to complete 5 repetitions
Timepoint [3] 366435 0
Within two weeks before the intervention and immediately after the intervention period
Secondary outcome [4] 366436 0
Walking quantity (steps per day, walking bouts per day, walking time) measured over 7 days with an activity monitor
Timepoint [4] 366436 0
Within two weeks before the intervention and immediately after the intervention period
Secondary outcome [5] 366437 0
Walking quality (step time variability) measured over 7 days with an activity monitor
Timepoint [5] 366437 0
Within two weeks before the intervention and immediately after the intervention period
Secondary outcome [6] 366438 0
Freezing of Gait using the New Freezing of Gait Questionnaire
Timepoint [6] 366438 0
Within two weeks before the intervention and immediately after the intervention period
Secondary outcome [7] 366439 0
Concern about falling using the Iconographical Falls Efficacy Scale
Timepoint [7] 366439 0
Within two weeks before the intervention and immediately after the intervention period
Secondary outcome [8] 366440 0
Quadriceps strength measured in sitting using a strain gauge
Timepoint [8] 366440 0
Within two weeks before the intervention and immediately after the intervention period
Secondary outcome [9] 366442 0
Physical activity measured with the Incidental and Planned Exercise Questionnaire for older people
Timepoint [9] 366442 0
Within two weeks before the intervention and immediately after the intervention period
Secondary outcome [10] 366443 0
Activities of daily living measured with the Movement Disorders Society – Unified Parkinson’s Disease Rating Scale Patient Questionnaire – Parts IB (non-motor aspects of daily living) and Part II (motor aspects of daily living)
Timepoint [10] 366443 0
Within two weeks before the intervention and immediately after the intervention period
Secondary outcome [11] 366444 0
Fatigue measured with the Multidimensional Fatigue Inventory
Timepoint [11] 366444 0
Within two weeks before the intervention and immediately after the intervention period
Secondary outcome [12] 366445 0
Self perceived change in balance, walking ability and fall risk measured on 11 point scale (-5 very much worse to 5 very much better)
Timepoint [12] 366445 0
Immediately after the intervention
Secondary outcome [13] 366509 0
Care- partner burden measured with the Zarit Burden Interview questionnaire
Timepoint [13] 366509 0
Within two weeks before the intervention and immediately after the intervention period
Secondary outcome [14] 366510 0
Fall rates collected using a falls calendar
Timepoint [14] 366510 0
Monthly, for a total of 14 months - 2 months prior to the intervention period, the 6 month intervention period, and 6 months following the intervention period.
Secondary outcome [15] 366512 0
Rate of fall related-injuries collected using the falls calendar
Timepoint [15] 366512 0
Monthly, for a total of 14 months - 2 months prior to the intervention period, the 6 month intervention period, and 6 months following the intervention period.
Secondary outcome [16] 366513 0
Number of fallers collected using falls calendars
Timepoint [16] 366513 0
Monthly, for a total of 14 months - 2 months prior to the intervention period, the 6 month intervention period, and 6 months following the intervention period.

Eligibility
Key inclusion criteria
At least 2 falls in the prior 6 months
No change in Parkinson's Disease medications 2 weeks prior to commencing the study
Ability to walk independently at least 10 meters with or without an aid.
Participants with significant cognitive impairment (Montreal Cognitive assessment <19 or,a level of functional cognition that the researchers deem requires assistance to participate) will require a care partner who is willing to participate with them to assist them with the intervention.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical conditions which would preclude or interfere with study safety and conduct.
Severe cognitive impairment (Montreal Cognitive Assessment < 5 )

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)
Participants will be randomly allocated to either the Integrate intervention group or the usual care control group . Randomisation will occur after the pre-test assessment and the results will be emailed to the researcher responsible for overseeing the intervention.
The computer generated random numbers table will only be accessible by the investigator performing the randomisation. This investigator will not be involved in the recruitment, intervention or assessments and will send the result of the randomisation to the researcher overseeing the intervention.
The researcher performing the post-test assessments will be blinded to participant group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Comptuerised random sequence generation. Randomisation will be stratified according to cognitive status, with participants grouped as having a Montreal Cognitive Assessment (MoCA) score of 15 of 23 or over vs under 23. Randomisation will occur through the use of a computer generated random number schedule with varaible blocks of sizes 2 to 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
Forty participants with idiopathic PD (and where appropriate, their care partners will be recruited and randomised 1: 1 (ie 20 per group) to the intervention and control (usual care) groups.
Between group comparisons of final test performance for the continuously scored outcome measures will be made using General Linear Models (ANCOVA) controlled for pre test performance. Between group differences in the Goal Attainment scale (ordinal outcome) will be assessed using ordinal logistic regression. An intention to treat approach will be used.
An estimate of the effect on falls will also be calculated using Poisson Inverse Gaussian regression, to inform sample size calculators for any future trial to determine the effect of the intervention on fall rates.

Recruitment
Recruitment status
Not yet 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)
NSW

Funding & Sponsors
Funding source category [1] 301857 0
Charities/Societies/Foundations
Name [1] 301857 0
Parkinson's NSW Research Grant
Address [1] 301857 0
Parkinson's NSW
Macquarie Hospital Building 17
51 Wicks Road, North Ryde 2113
NSW, Australia
Country [1] 301857 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 301602 0
None
Name [1] 301602 0
Address [1] 301602 0
Country [1] 301602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302552 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 302552 0
The University of Sydney
NSW 2006
Ethics committee country [1] 302552 0
Australia
Date submitted for ethics approval [1] 302552 0
05/12/2018
Approval date [1] 302552 0
11/03/2019
Ethics approval number [1] 302552 0
2019/034

Summary
Brief summary
As Parkinson's Disease (PD) progresses, people develop significant mobility limitations and falls despite optimal medical care. The objective of the research is to help people with advancing PD and their families to live better by maintaining safe mobility for longer. Many of the impairments commonly associated with PD contribute to mobility limitations, including impaired balance , freezing of gait and cognitive impairment.
The proposed project aims to to determine if a 6 month home based environmental, behavioral and exercise multi factorial intervention for people with PD improves mobility and safe mobility behaviors. Secondary aims are to determine the effect of the program on walking quantity and quality, leg muscle strength, FOG, concern about falling, activities of daily living and care partner burden.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90622 0
Dr Natalie Allen
Address 90622 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 90622 0
Australia
Phone 90622 0
+61293519016
Fax 90622 0
Email 90622 0
natalie.allen@sydney.edu.au
Contact person for public queries
Name 90623 0
Dr Natalie Allen
Address 90623 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 90623 0
Australia
Phone 90623 0
+61293519016
Fax 90623 0
Email 90623 0
natalie.allen@sydney.edu.au
Contact person for scientific queries
Name 90624 0
Dr Natalie Allen
Address 90624 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 90624 0
Australia
Phone 90624 0
+61293519016
Fax 90624 0
Email 90624 0
natalie.allen@sydney.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 other documents available
Summary results
No Results