ANZCTR - Registration

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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Idiopathic Parkinsons disease

Multiple System Atrophy

Progressive Supranuclear Palsy

Corticobasal Degeneration

Dementia with Lewy Bodies

Condition category

Condition code

Neurological

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Retention rates - assessed via an audit of study logs.

Timepoint [1]

Retention rates will be measured at the end of the 7-day EMA-survey-based data collection period.

Primary outcome [2]

Recruitment rates - assessed via an audit of study logs.

Timepoint [2]

Monthly recruitment rate with an estimated recruitment period of up to 6 months

Secondary outcome [1]

Self-reported weekly physical activity levels -
International Physical Activity Questionnaire – Version for elderly (IPAQ-E).

Timepoint [1]

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]

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]

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]

Self-reported perception of daytime sleepiness -
The Epworth Sleepiness Scale (ESS) will be used.

Timepoint [3]

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]

Self-reported perceptions of nocturnal sleep problems -
The Parkinson’s Disease Sleep Scale – version 2 (PDSS-2) will be used.

Timepoint [4]

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]

Self-reported perceptions of fatigue
- The Fatigue Severity Scale (FSS) will be used.

Timepoint [5]

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]

Pain -
The King’s PD Pain Questionnaire (KPPQ) will be used.

Timepoint [6]

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]

Apathy -
The Apathy Scale (AS), developed specifically for people with Parkinson's disease, will be used.

Timepoint [7]

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]

Anxiety symptoms -
The self-rated version of the Parkinson’s Anxiety Scale (PAS) will be used.

Timepoint [8]

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]

Depression symtpoms -
The 15-item Geriatric Depression Scale (GDS-15) will be used.

Timepoint [9]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

School of Physiotherapy Research Fund, University of Otago,

Address [1]

325 Great King Street, Dunedin North, Dunedin 9016

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee (Health)

Ethics committee address [1]

362 Leith Street, Dunedin North, Dunedin 9016

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

25/11/2022

Approval date [1]

25/01/2023

Ethics approval number [1]

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

Miss Amanda Still

Address

University of Otago, School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016

Country

New Zealand

Phone

+64 3 479 7460

Fax

amanda.still@otago.ac.nz

Contact person for public queries

Name

Amanda Still

Address

University of Otago, School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016

Country

New Zealand

Phone

+64 3 479 7460

Fax

amanda.still@otago.ac.nz

Contact person for scientific queries

Name

Prasath Jayakaran

Address

University of Otago, School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016

Country

New Zealand

Phone

+64 3 479 7411

Fax

prasath.jayakaran@otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
18260	Informed consent form			amanda.still@otago.ac.nz
18261	Ethical approval			amanda.still@otago.ac.nz

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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