Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000847516
Ethics application status
Approved
Date submitted
28/07/2015
Date registered
14/08/2015
Date last updated
27/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of the relationships between pain, physical activity, sleep and mood in people with Parkinson's disease
Scientific title
Do people with Parkinson's disease respond to exercise with the same exercise-induced analgesia response as the general older population?
Secondary ID [1] 287157 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 295720 0
pain 295721 0
Condition category
Condition code
Neurological 296002 296002 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All participants will be asked to perform one short bout of isometric upper limb exercise, in order to assess exercise induced analgesia/hyperalgesia. First, the participant’s maximal voluntary force will be determined by asking them to maximally contract their muscles against a force transducer. This procedure will be repeated two more times with the participant’s maximal voluntary contraction (i.e. 1RM) being the greatest force produced during the 3 trials. Following a short rest, participants will be asked to sustain an isometric contraction at a moderate intensity (i.e. 40% 1RM) for as long as possible with a maximum time of 3 minutes.

Following the assessment session, participants with PD will be asked to wear an activity and sleep monitoring device on their wrist and their waist for 7 consecutive days.
Intervention code [1] 292430 0
Not applicable
Comparator / control treatment
The exercise-induced analgesia/hyperalgesia response (i.e. any change in pressure pain threshold following exercise) of the participant's with Parkinson's disease will be compared to that of healthy age and gender-matched participants.

The healthy age and gender-matched participants will not be required to wear the activity and sleep monitors.
Control group
Active

Outcomes
Primary outcome [1] 295674 0
Pressure pain threshold measured with a pressure algometer will be collected for all participants.
Timepoint [1] 295674 0
Collected immediately before and after performing isometric exercise, at the assessment session.
Primary outcome [2] 295675 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] 295675 0
Collected once - at the assessment session before performing the isometric exercise.
Secondary outcome [1] 316183 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] 316183 0
Collected once - at the assessment session before performing the isometric exercise.
Secondary outcome [2] 316184 0
The Incidental and Planned Exercise Questionnaire will be used to measure physical activity. 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. This will be collected for all participants with PD.
Timepoint [2] 316184 0
Once - at the assessment session
Secondary outcome [3] 316185 0
The Pittsburgh Sleep Quality Index will be used to assess sleep quality for the previous month, and will be collected for all participants with PD.
Timepoint [3] 316185 0
Once - at the assessment session
Secondary outcome [4] 316186 0
The Epworth Sleepiness Scale will be used to assess day time sleepiness and will be collected for all participants with PD.
Timepoint [4] 316186 0
Once - at the assessment session
Secondary outcome [5] 316187 0
The REM Sleep Behaviour Disorder Questionnaire will be used to screen for REM sleep behaviour disorder and will be collected for all participants with PD.
Timepoint [5] 316187 0
Once - at the assessment session
Secondary outcome [6] 316188 0
The Hospital Anxiety and Depression Scale is a self-report questionnaire for measuring anxiety and depression in the past 7 days and will be collected for all participants with PD.
Timepoint [6] 316188 0
Collected at the assessment session and at the conclusion of the 7 days of activity and sleep monitoring.
Secondary outcome [7] 316189 0
Actigraphy measures of physical activity intensity will be collected for all participants with PD.
Timepoint [7] 316189 0
Measured for 7 days while wearing the activity and sleep monitor.
Secondary outcome [8] 316190 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 PD.
Timepoint [8] 316190 0
Measured for 7 days while wearing the activity and sleep monitor
Secondary outcome [9] 316191 0
Daily measure of pain severity (score out of 10) will be collected for all participants with PD.
Timepoint [9] 316191 0
Measured for 7 days while wearing the activity and sleep monitor.
Secondary outcome [10] 316192 0
Daily measures of physical activity recorded as a summary of activities undertaken through the day will be collected for all participants with PD.
Timepoint [10] 316192 0
Measured for 7 days while wearing the activity and sleep monitor, in order to verify activity monitor data.
Secondary outcome [11] 316194 0
Daily measures of sleep recorded as a description of the previous night's sleep will be collected for all participants with PD.
Timepoint [11] 316194 0
Measured for 7 days while wearing the activity and sleep monitor, to verify sleep monitor data.
Secondary outcome [12] 316374 0
Actigraphy measures of the number of steps taken will be collected for all participants with PD.
Timepoint [12] 316374 0
Measured for 7 days while wearing the activity and sleep monitor.
Secondary outcome [13] 316375 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 PD.
Timepoint [13] 316375 0
Measured for 7 days while wearing the activity and sleep monitor.
Secondary outcome [14] 316376 0
Actigraphy measures of the minutes between lights off and first sleep episode (i.e. sleep latency) will be collected for all participants with PD.
Timepoint [14] 316376 0
Measured for 7 days while wearing the activity and sleep monitor.
Secondary outcome [15] 316377 0
Actigraphy measures of the minutes awake between sleep onset and wake time (wake after sleep onset) will be collected for all participants with PD.
Timepoint [15] 316377 0
Measured for 7 days while wearing the activity and sleep monitor.
Secondary outcome [16] 316378 0
Daily measure of pain interference with activity - score out of 10.
Timepoint [16] 316378 0
Measured for 7 days while wearing the activity and sleep monitor.
Secondary outcome [17] 316379 0
Parkinson's disease severity will be measured with the Movement Disorders Society-sponsored Unified Parkinson's Disease Rating Scale for all participants with PD.
Timepoint [17] 316379 0
Measured once at the assessment session.
Secondary outcome [18] 316380 0
Parkinson's disease -related quality of life will be measured with the PDQ-39 for all participants with PD.
Timepoint [18] 316380 0
Measured once at the assessment session.
Secondary outcome [19] 316381 0
The Central Sensitisation Inventory (a screening instrument to identify people who may have central sensitivity syndrome) will be collected for all participants with PD.
Timepoint [19] 316381 0
Measured once at the assessment session.
Secondary outcome [20] 316382 0
The King's Pain Scale will be measured to collect background information about pain in participant's with PD.
Timepoint [20] 316382 0
Measured once at the assessment session before performing the isometric exercise.

Eligibility
Key inclusion criteria
Aged 40 years or over, living in the community.
Participants with Parkinson's disease will be required to have had no changes to their usual Parkinson's disease medications in the prior 2 weeks.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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 an upper limb problem which would preclude the upper limb isometric exercise.
People without Parkinson's disease who experience significant pain (i.e. pain of >3/10 intensity for at least 2 days per week in the prior 3 months)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/08/2015
Actual
28/08/2015
Date of last participant enrolment
Anticipated
5/12/2016
Actual
4/07/2016
Date of last data collection
Anticipated
Actual
11/07/2016
Sample size
Target
85
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291729 0
University
Name [1] 291729 0
The University of Sydney
Country [1] 291729 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] 290404 0
None
Name [1] 290404 0
Address [1] 290404 0
Country [1] 290404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293252 0
The University of Sydney
Ethics committee address [1] 293252 0
The University of Sydney,
Parramatta Rd,
NSW, Australia, 2006
Ethics committee country [1] 293252 0
Australia
Date submitted for ethics approval [1] 293252 0
03/07/2015
Approval date [1] 293252 0
03/08/2015
Ethics approval number [1] 293252 0
2015/574

Summary
Brief summary
The primary purpose of this study is to investigate if people with Parkinson's disease have the usual reduction in pain threshold following exercise (i.e. exercise induced analgesia). We hypothesize that people with Parkinson's disease will have the usual exercise-induced analgesia response to exercise.

The secondary purpose is to investigate the relationships between measures of exercise-induced analgesia with pain, physical activity levels, sleep quality and mood in people with Parkinson’s disease and the relationships between physical activity levels, sleep quality, mood and pain in people with Parkinson’s disease. We hypothesize that increased physical activity, better sleep and better mood will be associated with a better exercise-induced analgesia response and with less pain in people with Parkinson's disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59086 0
Dr Natalie Allen
Address 59086 0
Faculty of Health Sciences,
The University of Sydney,
PO Box 170,
Lidcombe, NSW, 1825.
Country 59086 0
Australia
Phone 59086 0
+61293519016
Fax 59086 0
Email 59086 0
[email protected]
Contact person for public queries
Name 59087 0
Dr Natalie Allen
Address 59087 0
Faculty of Health Sciences,
The University of Sydney,
PO Box 170,
Lidcombe, NSW, 1825.
Country 59087 0
Australia
Phone 59087 0
+61293519016
Fax 59087 0
Email 59087 0
[email protected]
Contact person for scientific queries
Name 59088 0
Dr Natalie Allen
Address 59088 0
Faculty of Health Sciences,
The University of Sydney,
PO Box 170,
Lidcombe, NSW, 1825.
Country 59088 0
Australia
Phone 59088 0
+61293519016
Fax 59088 0
Email 59088 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseExercise-induced hypoalgesia is present in people with Parkinson's disease: Two observational cross-sectional studies.2019https://dx.doi.org/10.1002/ejp.1400
N.B. These documents automatically identified may not have been verified by the study sponsor.