Trial Review

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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
ACTRN12622000079741
Ethics application status
Approved
Date submitted
15/12/2021
Date registered
21/01/2022
Date last updated
26/04/2023
Date data sharing statement initially provided
21/01/2022
Date results information initially provided
26/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise and peritoneal dialysis, is it safe?
Scientific title
Frequency and characteristics of adverse events related to exercise or physical activity for people receiving peritoneal dialysis
Secondary ID [1] 306057 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease and receiving peritoneal dialysis 324700 0
Condition category
Condition code
Renal and Urogenital 322152 322152 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
People receiving peritoneal dialysis will be invited to complete an online survey asking about adverse events they have experienced either during, or soon after, completing physical activity or exercise. The study will be a cross-sectional national survey. Participants will be invited to anonymously complete the online survey to be accessed through either a URL link or QR Code. It contains 37 individual questions and is completed only once. It is anticipated that the survey will take ~10-15 minutes to complete.
Intervention code [1] 322462 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329919 0
1. Adverse events assessed through a study-specific questionnaire.

(Dizzy, Nausea, Muscle Twitches or Cramps Muscle Soreness of Pain, Short of Breath, Vomited, Tired, Sleep Problems, Anxious or Low Mood, Chest Pain, Fainted, Fall, Blood Pressure go High, Blood Pressure go Low, Blood Sugar Levels go High, Blood Sugar Levels go Low, Stomach Pain or Discomfort, Headaches, Bloated Abdomen, Problem with the Dialysis Catheter, Hernia, Stroke, Any other symptom / side-effect, injury or health event)
Timepoint [1] 329919 0
Once only at the time of enrolment.
Primary outcome [2] 330057 0
2. Cause of the adverse event (Exercise, Physical Activity, Both) through a study-specific questionnaire.

Timepoint [2] 330057 0
At the time of enrolment
Primary outcome [3] 330058 0
3. Severity / Impact of the adverse event (None, Low, Mild, Severe) will be assessed as a composite primary outcome through a study-specific questionnaire.

4. Frequency of the adverse event (rarely, occasionally, all the time) will be assessed as a composite primary outcome through a study-specific questionnaire.

5. Management of the adverse event (hospitalised, GP visit, medicated, self-managed etc.) will be assessed as a composite primary outcome through a study-specific questionnaire.

Timepoint [3] 330058 0
At the time of enrolment
Secondary outcome [1] 404768 0
Nil
Timepoint [1] 404768 0
N/A

Eligibility
Key inclusion criteria
Adults (aged 18 or over) will be recruited from end stage kidney disease patients receiving any form of peritoneal dialysis within Australia and New Zealand
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to understand English or have adequate translator services available.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to describe participant demographics, dialysis / medical history. Adverse event health event, frequency, potential cause, impact and care received data will be presented as whole numbers with narrative synthesis performed given the anticipated heterogeneity of the data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/02/2022
Actual
14/02/2022
Date of last participant enrolment
Anticipated
31/01/2023
Actual
27/08/2022
Date of last data collection
Anticipated
31/01/2023
Actual
27/08/2022
Sample size
Target
150
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21342 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 36233 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 24448 0
New Zealand
State/province [1] 24448 0

Funding & Sponsors
Funding source category [1] 310395 0
University
Name [1] 310395 0
University of South Australia
Country [1] 310395 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 311543 0
None
Name [1] 311543 0
Address [1] 311543 0
Country [1] 311543 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310044 0
Central Adelaide Local Health Network
Ethics committee address [1] 310044 0
The Queen Elizabeth Hospital Ground Floor, Basil Hetzel Institute 28 Woodville Road WOODVILLE SOUTH SA 5011
Ethics committee country [1] 310044 0
Australia
Date submitted for ethics approval [1] 310044 0
18/10/2021
Approval date [1] 310044 0
11/11/2021
Ethics approval number [1] 310044 0
2021/HRE00362

Summary
Brief summary
Exercise has the potential to enhance the quality of life for people receiving peritoneal dialysis, however, there is concern regarding risk. It is vital to understand risks associated with exercise and physical activity for people receiving peritoneal dialysis. Thus, the aim of this survey is to address this knowledge gap by exploring the characteristics and frequency of adverse health events reported by people receiving peritoneal dialysis related to exercise or physical activity.

Participants will anonymously complete a survey that takes them through a list of adverse events asking if they have experienced the respective event either during, or soon after participation in physical activity or exercise.

Identification of these events will provide increased understanding of the safety of exercise or physical activity for this population. This will enhance the ability of patients and clinicians to make evidence informed decisions regarding possible risks while awaiting the necessary rigorous intervention and adverse event data.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116294 0
Mr Brett Tarca
Address 116294 0
Att: Brett Tarca (P2-42a) University of South Australia Reply Paid 2471 Adelaide, SA 5001
Country 116294 0
Australia
Phone 116294 0
+61 8 8302 2906
Fax 116294 0
Email 116294 0
brett.tarca@mymail.unisa.edu.au
Contact person for public queries
Name 116295 0
Mr Brett Tarca
Address 116295 0
Att: Brett Tarca (P2-42a) University of South Australia Reply Paid 2471 Adelaide, SA 5001
Country 116295 0
Australia
Phone 116295 0
+61 8 8302 2906
Fax 116295 0
Email 116295 0
brett.tarca@mymail.unisa.edu.au
Contact person for scientific queries
Name 116296 0
Mr Brett Tarca
Address 116296 0
Att: Brett Tarca (P2-42a) University of South Australia Reply Paid 2471 Adelaide, SA 5001
Country 116296 0
Australia
Phone 116296 0
+61 8 8302 2906
Fax 116296 0
Email 116296 0
brett.tarca@mymail.unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case by case basis at the discretion of the research team.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator (brett.tarca@mymail.unisa.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14449Other    Participant Information Sheet 383309-(Uploaded-15-12-2021-14-28-57)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4866Study results articleYeshttps://doi.org/10.1053/j.jrn.2023.12.003 Characteristics and Frequency of Physical Activity and Exercise-Related Side-Effects.pdf

Documents added automatically
No additional documents have been identified.