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Trial registered on ANZCTR


Registration number
ACTRN12616001143415
Ethics application status
Approved
Date submitted
17/08/2016
Date registered
23/08/2016
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of the relationships between pain, aerobic exercise, physical activity, sleep and mood in people with Parkinson's disease.
Scientific title
Do people with Parkinson's disease respond to aerobic exercise with the same exercise-induced analgesia response as the general older population?
Secondary ID [1] 289602 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 299381 0
Pain 299382 0
Condition category
Condition code
Neurological 299365 299365 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be asked to perform 2 separate bouts of aerobic treadmill walking exercise, around 1 to 2 weeks apart, in order to assess exercise induced analgesia/hyperalgesia. The exercise will be supervised by an accredited exercise physiologist or a registered physiotherapist. The duration of the exercise will be 10 to 25 min, depending on the fitness and walking capacity of the participant. The two sessions of treadmill walking will be performed at different intensities, one at low intensity (Rating of Perceived exertion (RPE) 9-10 out of 20 – light exercise) and one at a higher intensity (RPE 12-13 out of 20 – moderate exercise). The order of the walking intensity will be randomised using a computer-generated table.
Participants with PD will be asked to wear an activity and sleep monitoring device on their wrist and their waist for 7 consecutive days between the two treadmill walking sessions.
Comparator / control treatment
The exercise-induced analgesia/hyperalgesia response of the participant's with Parkinson's disease at the two different walking intensities will be compared to that of age and gender-matched participants without Parkinson's disease and pain.
Control group
Active

Outcomes
Primary outcome [1] 298832 0
Pressure pain threshold measured with a pressure algometer.
Timepoint [1] 298832 0
Collected immediately before and after each bout of treadmill walking, at the assessment sessions.
Primary outcome [2] 298833 0
Pain will be assessed using the Brief Pain Inventory, which assesses pain severity and the impact of pain on daily activities in the past week. This will be collected for people with PD who experience pain.
Timepoint [2] 298833 0
Participants will complete this once – they will be provided with it at the first assessment session and will return it at the second session.
Secondary outcome [1] 325359 0
The Pain Self-Efficacy Questionnaire assesses how confident people are that they can do their daily activities despite any pain they have and will be collected for people with PD who experience pain.
Timepoint [1] 325359 0
Participants will complete this once – they will be provided with it at the first assessment session and will return it at the second session.
Secondary outcome [2] 325360 0
The Incidental and Planned Exercise Questionnaire will be used to measure physical activity in participants with Parkinson's disease. It is a self-report questionnaire that covers the frequency and duration of several levels of planned and incidental physical activity in the previous 3 months in older people. It assesses the level of physical activity relating to both basic and more demanding activities.
Timepoint [2] 325360 0
Participants will complete this once – they will be provided with it at the first assessment session and will return it at the second session.
Secondary outcome [3] 325361 0
The Pittsburgh Sleep Quality Index will be used to assess sleep quality for the previous month in participants with Parkinson's disease.
Timepoint [3] 325361 0
Participants will complete this once – they will be provided with it at the first assessment session and will return it at the second session.
Secondary outcome [4] 325362 0
The Epworth Sleepiness Scale will be used to assess day time sleepiness in participants with Parkinson's disease
Timepoint [4] 325362 0
Participants will complete this once – they will be provided with it at the first assessment session and will return it at the second session.
Secondary outcome [5] 325363 0
The REM Sleep Behaviour Disorder Questionnaire will be used to screen for REM sleep behaviour disorder in participants with Parkinson's disease
Timepoint [5] 325363 0
Participants will complete this once – they will be provided with it at the first assessment session and will return it at the second session.
Secondary outcome [6] 325364 0
The Hospital Anxiety and Depression Scale is a self-report questionnaire for measuring anxiety and depression in the past 7 days. It will be completed by participants with Parkinson's disease.
Timepoint [6] 325364 0
Collected at the first assessment session and at the conclusion of the 7 days of activity and sleep monitoring.
Secondary outcome [7] 325366 0
Actigraphy measures of physical activity intensity will be measured for participants with Parkinson's disease.
Timepoint [7] 325366 0
Measured for 7 consecutive days between test session 1 and 2 while wearing the activity and sleep monitor.
Secondary outcome [8] 325367 0
Actigraphy measures of the number of steps taken will be measured for people with Parkinson's disease.
Timepoint [8] 325367 0
Measured for 7 consecutive days between test session 1 and 2 while wearing the activity and sleep monitor
Secondary outcome [9] 325368 0
Daily measures of pain severity (score out of 10) will be collected for all participants with Parkinson's disease.
Timepoint [9] 325368 0
Measured for 7 consecutive days between test session 1 and 2 while wearing the activity and sleep monitor.
Secondary outcome [10] 325699 0
Daily measure of pain interference with activity (score out of 10) will be collected for all participants with PD.
Timepoint [10] 325699 0
Measured for 7 consecutive days between test session 1 and 2 while wearing the activity and sleep monitor
Secondary outcome [11] 325703 0
Daily measures of physical activity recorded as a summary of activities undertaken through the day will be collected for all participants with Parkinson's disease.
Timepoint [11] 325703 0
Measured for 7 consecutive days between test session 1 and 2 while wearing the activity and sleep monitor, in order to verify activity monitor data.
Secondary outcome [12] 325704 0
Actigraphy measures of the percentage of time asleep while in bed from lights off to lights on (i.e. sleep efficiency) will be collected for all participants with Parkinson's disease.
Timepoint [12] 325704 0
Measured for 7 consecutive days between test session 1 and 2 while wearing the activity and sleep monitor
Secondary outcome [13] 325705 0
Actigraphy measures of the minutes of sleep between sleep onset and wake time (i.e. total sleep time) will be collected for all participants with Parkinson's disease.
Timepoint [13] 325705 0
Measured for 7 consecutive days between test session 1 and 2 while wearing the activity and sleep monitor.
Secondary outcome [14] 325706 0
Actigraphy measures of the minutes between lights off and first sleep episode (i.e. sleep latency) will be collected for all participants with Parkinson's disease.
Timepoint [14] 325706 0
Measured for 7 consecutive days between test session 1 and 2 while wearing the activity and sleep monitor
Secondary outcome [15] 325707 0
Actigraphy measures of the minutes awake between sleep onset and wake time (wake after sleep onset) will be collected for all participants with Parkinson's disease.
Timepoint [15] 325707 0
Measured for 7 consecutive days between test session 1 and 2 while wearing the activity and sleep monitor
Secondary outcome [16] 325708 0
Daily measures of sleep recorded as a description of the previous night's sleep will be collected for all participants with Parkinson's disease.
Timepoint [16] 325708 0
Measured for 7 consecutive days between test session 1 and 2 while wearing the activity and sleep monitor, to verify sleep monitor data.
Secondary outcome [17] 325709 0
Parkinson's disease severity will be measured with the Movement Disorders Society-sponsored Unified Parkinson's Disease Rating Scale for all participants with Parkinson's disease.
Timepoint [17] 325709 0
Measured once at the first assessment session.
Secondary outcome [18] 325710 0
Parkinson's disease -related quality of life will be measured with the PDQ-39 for all participants with Parkinson's disease.
Timepoint [18] 325710 0
Participants will complete this once – they will be provided with it at the first assessment session and will return it at the second session.
Secondary outcome [19] 325711 0
The Central Sensitisation Inventory (a screening instrument to identify people who may have central sensitivity syndrome) will be collected for all participants with Parkinson's disease.
Timepoint [19] 325711 0
Participants will complete this once – they will be provided with it at the first assessment session and will return it at the second session.
Secondary outcome [20] 325712 0
The King's Pain Scale will be measured to collect information about pain in participant's with Parkinson's disease.
Timepoint [20] 325712 0
Measured once at the first assessment session before performing the treadmill walking exercise.

Eligibility
Key inclusion criteria
People with PD:
Aged 40 years or over, living in the community and are able to walk at least 200m with or without a walking aid.
No changes to their usual Parkinson's disease medications in the prior 2 weeks.

Healthy Control Group
Aged 40 years or over, living in the community
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with PD:
People with neurological impairments other than those due to Parkinson's disease.
People with substantial cognitive impairment (i.e. mini-mental state examination below 24)
People with pain due to a known radiculopathy (i.e. a compressed nerve of the spine) or another diagnosed chronic pain condition (e.g. fibromyalgia) that is likely to interfere with the evaluation of the person’s safety and of the study outcome.
People with uncontrolled cardiovascular, metabolic or renal disease.

Healthy control group
People with neurological impairments.
People with substantial cognitive impairment (i.e. mini-mental state examination below 24)
People who experience significant pain (i.e. pain of >3/10 intensity for at least 2 days per week in the prior 3 months)
People with pain due to a known radiculopathy (i.e. a compressed nerve of the spine) or another diagnosed chronic pain condition (e.g. fibromyalgia) that is likely to interfere with the evaluation of the person’s safety and of the study outcome.
People with uncontrolled cardiovascular, metabolic or renal disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2016
Actual
12/10/2016
Date of last participant enrolment
Anticipated
31/12/2017
Actual
29/08/2017
Date of last data collection
Anticipated
30/04/2018
Actual
12/09/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293986 0
Charities/Societies/Foundations
Name [1] 293986 0
Parkinson's NSW
Country [1] 293986 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney,
Parramatta Rd, NSW, Australia
2006
Country
Australia
Secondary sponsor category [1] 292804 0
None
Name [1] 292804 0
Address [1] 292804 0
Country [1] 292804 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295473 0
The University of Sydney HREC
Ethics committee address [1] 295473 0
Ethics committee country [1] 295473 0
Australia
Date submitted for ethics approval [1] 295473 0
06/06/2016
Approval date [1] 295473 0
16/08/2016
Ethics approval number [1] 295473 0
2016/593

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

Contacts
Principal investigator
Name 67166 0
Dr Natalie Allen
Address 67166 0
Faculty of Health Sciences, The University of Sydney, PO Box 170,
Lidcombe, NSW, 1825.
Country 67166 0
Australia
Phone 67166 0
+61293519016
Fax 67166 0
Email 67166 0
natalie.allen@sydney.edu.au
Contact person for public queries
Name 67167 0
Natalie Allen
Address 67167 0
Faculty of Health Sciences, The University of Sydney, PO Box 170,
Lidcombe, NSW, 1825.
Country 67167 0
Australia
Phone 67167 0
+61293519016
Fax 67167 0
Email 67167 0
natalie.allen@sydney.edu.au
Contact person for scientific queries
Name 67168 0
Natalie Allen
Address 67168 0
Faculty of Health Sciences, The University of Sydney, PO Box 170,
Lidcombe, NSW, 1825.
Country 67168 0
Australia
Phone 67168 0
+61293519016
Fax 67168 0
Email 67168 0
natalie.allen@sydney.edu.au

No information has been provided regarding IPD availability


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.