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Trial registered on ANZCTR


Registration number
ACTRN12623000263695
Ethics application status
Approved
Date submitted
7/02/2023
Date registered
13/03/2023
Date last updated
13/03/2023
Date data sharing statement initially provided
13/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Relationships between physical activity and non-motor symptoms in people with Parkinsons disease and related conditions: Survey
Scientific title
Relationships between physical activity and non-motor symptoms in people with Parkinsons disease and related conditions: Survey
Secondary ID [1] 308906 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Parkinsons disease 328904 0
Multiple System Atrophy 328905 0
Progressive Supranuclear Palsy 329248 0
Corticobasal Degeneration 329249 0
Dementia with Lewy Bodies 329250 0
Condition category
Condition code
Neurological 325896 325896 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
Conditions observed:
1) Physical activity behaviour
2) Five non-motor symptoms = affect, pain, sleep, cognition, and fatigue.

Duration of observation: Seven consecutive days

What is involved for Participants:
1) Complete three short daily questionnaires for seven days (estimated five minutes each).
These will be completed via the m-path app which is a free-to-download smartphone application. For participants who are not able to use a smartphone, paper-based copies of the questionnaires will be provided.
2) Complete one longer set of questions (estimated time 60 minutes). These questionnaires will require participants to recall their physical activity behaviours and non-motor symptom experiences over the past seven days post-completion of the seven-day EMA-based questions.
3) Complete one motor symptom assessment via video call if possible (estimated time 20 minutes).
We will require a total of two to three hours of each participant's time across eight days.
Intervention code [1] 325346 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333774 0
Retention rates - assessed via an audit of study logs.
Timepoint [1] 333774 0
Retention rates will be measured at the end of the 7-day EMA-survey-based data collection period.
Primary outcome [2] 334079 0
Recruitment rates - assessed via an audit of study logs.
Timepoint [2] 334079 0
Monthly recruitment rate with an estimated recruitment period of up to 6 months
Secondary outcome [1] 418248 0
Self-reported weekly physical activity levels -
International Physical Activity Questionnaire – Version for elderly (IPAQ-E).
Timepoint [1] 418248 0
Participants will be asked to recall their physical activity levels over the past seven consecutive days. This questionnaire will be delivered post-completion of the 7-day EMA-based survey.
Secondary outcome [2] 419297 0
Self-reported perception of cognitive function -
The short form “Cognitive Function” domain of the Quality of Life in Neurological Disorders (Neuro-QOL) measure will be used.
Timepoint [2] 419297 0
Participants will be asked to recall their cognitive function over the past seven consecutive days. This questionnaire will be delivered post-completion of the 7-day EMA-based survey.
Secondary outcome [3] 419299 0
Self-reported perception of daytime sleepiness -
The Epworth Sleepiness Scale (ESS) will be used.
Timepoint [3] 419299 0
Participants will be asked to recall any daytime sleepiness they experienced over the past seven consecutive days. This questionnaire will be delivered post-completion of the 7-day EMA-based survey.
Secondary outcome [4] 419300 0
Self-reported perceptions of nocturnal sleep problems -
The Parkinson’s Disease Sleep Scale – version 2 (PDSS-2) will be used.
Timepoint [4] 419300 0
Participants will be asked to recall any nocturnal sleep problems they experienced over the past seven consecutive days. This questionnaire will be delivered post-completion of the 7-day EMA-based survey.
Secondary outcome [5] 419301 0
Self-reported perceptions of fatigue
- The Fatigue Severity Scale (FSS) will be used.
Timepoint [5] 419301 0
Participants will be asked to recall any feelings of fatigue they experienced over the past seven consecutive days. This questionnaire will be delivered post-completion of the 7-day EMA-based survey.
Secondary outcome [6] 419302 0
Pain -
The King’s PD Pain Questionnaire (KPPQ) will be used.
Timepoint [6] 419302 0
Participants will be asked to recall any painful experiences over the past seven consecutive days. This questionnaire will be delivered post-completion of the 7-day EMA-based survey.
Secondary outcome [7] 419303 0
Apathy -
The Apathy Scale (AS), developed specifically for people with Parkinson's disease, will be used.
Timepoint [7] 419303 0
Participants will be asked to recall any states of apathy experienced over the past seven consecutive days. This questionnaire will be delivered post-completion of the 7-day EMA-based survey.
Secondary outcome [8] 419304 0
Anxiety symptoms -
The self-rated version of the Parkinson’s Anxiety Scale (PAS) will be used.
Timepoint [8] 419304 0
Participants will be asked to recall any anxious symptoms experienced over the past seven consecutive days. This questionnaire will be delivered post-completion of the 7-day EMA-based survey.
Secondary outcome [9] 419305 0
Depression symtpoms -
The 15-item Geriatric Depression Scale (GDS-15) will be used.
Timepoint [9] 419305 0
Participants will be asked to recall any symptoms of depression experienced over the past seven consecutive days. This questionnaire will be delivered post-completion of the 7-day EMA-based survey.

Eligibility
Key inclusion criteria
- Self-declared diagnosis of idiopathic Parkinsons disease or atypical parkinsonism disorders (Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration and Dementia with Lewy Bodies)
- Adults over 18 years of age
- Able to read, understand and respond in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil.

For participants who are unable to provide informed consent due to cognitive impairment a supported decision-making process will be used with the help of their chosen caregivers and support persons.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample size justification:
Fifty participants will be sought based on previous observational and feasibility ecological momentary assessment (EMA) studies involving people with parkinsonism (n = 5 - 20) and to account for possible participant dropout to determine the feasibility of this protocol.

Analysis plan:
Simple descriptive statistics will be used to report demographic information, clinical characteristics and EMA responses. These descriptive statistics will be used to describe the characteristics of the sample and estimate the sample size needed to design the main quantitative study, which will be implemented in a larger national cohort of people with parkinsonism in New Zealand and Australia. Recruitment and retention rates will also be reported descriptively.

The following EMA-related data will also be reported as recommended by the adapted STROBE Checklist for Reporting EMA Studies; (1) EMA response rates, (4) EMA response latency time, (5) the number of planned prompts versus the number of prompts received with reasons given if known, (6) the duration of the EMA assessment, (7) the number of complete records with timely compliance, (8) the number of complete records with untimely compliance, (9) the number of incomplete records with at least one missing data and (10) the number of incomplete records.

Finally, where possible a preliminary analysis of the relationship between the five non-motor symptoms of interest and physical activity behaviours over the past seven consecutive days will be explored using correlation or regression analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2023
Actual
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
7/10/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 25250 0
New Zealand
State/province [1] 25250 0

Funding & Sponsors
Funding source category [1] 313140 0
University
Name [1] 313140 0
School of Physiotherapy Research Fund, University of Otago,
Country [1] 313140 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street, Dunedin North, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 314841 0
None
Name [1] 314841 0
Address [1] 314841 0
Country [1] 314841 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312363 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 312363 0
362 Leith Street, Dunedin North, Dunedin 9016
Ethics committee country [1] 312363 0
New Zealand
Date submitted for ethics approval [1] 312363 0
25/11/2022
Approval date [1] 312363 0
25/01/2023
Ethics approval number [1] 312363 0
H22/152

Summary
Brief summary
More than 90% of people living with parkinsonism experience non-motor symptoms more frequently and severely than unimpaired people of the same age and gender. Cognitive problems, mood disorders (depression, anxiety, apathy), pain, sleep and wakefulness problems, and fatigue are among the most frequent of these symptoms. Furthermore, these symptoms are reported to contribute to poor health-related quality of life, and some studies suggest this may be more so than that for parkinsonism motor symptoms.

The presence of a close symptom-to-symptom interaction between the five non-motor symptoms of interest has been observed in a recent study. Though this finding warrants further exploration, it may provide meaningful insight into how to best manage the collective burden of these symptoms.

Emerging evidence from intervention studies suggests that participation in physical exercise may offer potential benefits for managing these non-motor symptoms when usual pharmaceutical care offers limited effectiveness and unwanted side effects. Despite the potential benefits of exercise, physical activity levels among people with parkinsonism often decline following diagnosis and are significantly less than for unimpaired people of the same age.

Daily fluctuations in the presence and severity of non-motor symptoms arguably influence daily physical activity behaviour. While worse non-motor symptoms may considerably contribute to the physical inactivity observed by people with parkinsonism, no study has specifically focused on this potential association.

This study aims to evaluate the feasibility of using a repeated daily questionnaire delivered for seven consecutive days to monitor daily non-motor symptoms and physical activity behaviour in people with parkinsonism from a New Zealand population. If feasibility is shown, more extensive cohort studies may use the questionnaire to explore (1) the interrelationship between the five non-motor symptoms of interest, (2) whether these symptoms are affected by variations in daily and weekly habitual physical activity behaviour, and (3) whether these symptoms influence daily and weekly habitual physical activity participation.
Trial website
https://www.otago.ac.nz/physio/research/research-studies/otago0241457.html
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124390 0
Miss Amanda Still
Address 124390 0
University of Otago, School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016
Country 124390 0
New Zealand
Phone 124390 0
+64 3 479 7460
Fax 124390 0
Email 124390 0
[email protected]
Contact person for public queries
Name 124391 0
Amanda Still
Address 124391 0
University of Otago, School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016
Country 124391 0
New Zealand
Phone 124391 0
+64 3 479 7460
Fax 124391 0
Email 124391 0
[email protected]
Contact person for scientific queries
Name 124392 0
Prasath Jayakaran
Address 124392 0
University of Otago, School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016
Country 124392 0
New Zealand
Phone 124392 0
+64 3 479 7411
Fax 124392 0
Email 124392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant consent is being sought for the data to be used in the current study only.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18260Informed consent form  [email protected]
18261Ethical approval  [email protected]



Results publications and other study-related documents

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