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Trial registered on ANZCTR
Registration number
ACTRN12624001063505
Ethics application status
Approved
Date submitted
1/07/2024
Date registered
3/09/2024
Date last updated
3/09/2024
Date data sharing statement initially provided
3/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
The Effect of a Prehabilitation Exercise Program on Peritoneal Dialysis Outcomes: A Feasibility Study
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Scientific title
The Effect of a Prehabilitation Exercise Program on Peritoneal Dialysis Outcomes: A Feasibility Study
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Secondary ID [1]
312374
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
CORE-PD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Kidney Failure
334163
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Condition category
Condition code
Renal and Urogenital
330834
330834
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0
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Kidney disease
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Physical Medicine / Rehabilitation
331436
331436
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants in the Intervention Group will complete an exercise-based intervention. The program will be guided by consumers and currently published guidelines for people receiving peritoneal dialysis and chronic kidney disease. It will contain core abdominal, lower body and upper body strengthening exercises and, cardiovascular conditioning through a modality of the participants choice (walking, cycling etc.) to be prescribed by the exercise physiologist. Exercise physiologists are university qualified allied health professionals equipped with the knowledge, skills and competencies to design, deliver and evaluate safe and effective exercise interventions for people with chronic medical conditions.
The intervention will involve two key components.
1) Pre-Catheter Insertion
1 x 1 hour face to face or Zoom meeting with the study exercise physiologist upon recruitment to the intervention arm and, prior to the peritoneal dialysis catheter insertion. The exercise physiologist will be informed by the medical history of the participant and prescribe a tailored home-based exercise program in addition to education on exercise-related considerations (e.g. exercise preferences, previous injuries, blood pressure, blood glucose levels (if diabetic) etc.) specific to their medical history. This program will involve resistance bands and a gym ball, to be provided to each participant. The exercise physiologist will follow-up with the participant two weeks after this consult to ensure the participant is exercising safely and correctly and, to enquire about adverse events.
2) Post- Catheter Insertion
At four weeks following catheter insertion, the exercise physiologist will meet with the participant at their regular post catheter insertion appointment. Following this, 1 x 15-minute telehealth weekly call (via phone/Teams/Zoom) will be performed for 8-weeks from the exercise physiologist in the post-catheter insertion phase to provide advice, counselling (program progression / regression) and enquire about adverse events. The exercise physiologist will pay particular consideration to the catheter and prescribe a program that focuses on a gradual and safe return to pre-catheter exercises. Note that these calls will only be completed whilst the participant is completing the intervention (i.e. not in the 4 week period post-peritoneal dialysis catheter insertion).
The exercise program in both phases will be guided by published guidelines for people receiving peritoneal dialysis and general guidelines published for people living with chronic kidney disease,
[Bennett, P. N., Bohm, C., Harasemiw, O., Brown, L., Gabrys, I., Jegatheesan, D., ... & Thompson, S. (2022). Physical activity and exercise in peritoneal dialysis: International Society for Peritoneal Dialysis and the Global Renal Exercise Network practice recommendations. Peritoneal Dialysis International, 42(1), 8-24.]
[Smart, N. A., Williams, A. D., Levinger, I., Selig, S., Howden, E., Coombes, J. S., & Fassett, R. G. (2013). Exercise & Sports Science Australia (ESSA) position statement on exercise and chronic kidney disease. Journal of Science and Medicine in Sport, 16(5), 406-411.]
These guidelines recommend people receiving peritoneal dialysis complete approximately 150mins of moderate physical activity per week. However, the exercise physiologist will apply clinical expertise to prescribe participants a graded program aimed at progressing towards these goals that will be guided by the participants current activity levels and medical history. This is to ensure safety and that the program is achievable.
Intervention Duration
The intervention will be delivered in two phases; 1) pre-catheter insertion phase prior to insertion of the peritoneal dialysis catheter (this will vary from 30-90 days pre-catheter insertion) and 2) 8-week post-catheter insertion phase following the peritoneal dialysis catheter insertion. The commencement of the second 8-week phase will not begin within 4-weeks post-peritoneal dialysis catheter insertion when physical lifting and strenuous exercise restrictions are already in place by treating clinicians.
Adherence in both phases will be monitored weekly via a survey that is sent via SMS asking participants to self-report how many sessions they completed over the previous 7-days.
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Intervention code [1]
328870
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Lifestyle
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Comparator / control treatment
Usual care, defined as the typical care received consisting of assessments and treatments considered necessary for an individual commencing dialysis. These typically involve consultations with nephrologists and home dialysis nurses to train the person to self-manage their treatment and prepare them for life on dialysis. This does not involve any counselling or prescription of exercise or physical activity.
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Control group
Active
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Outcomes
Primary outcome [1]
338683
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Feasibility - Adherence
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Assessment method [1]
338683
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Participants in the intervention group will be asked weekly to report the total number of exercise sessions they had completed over the previous 7-days. This data will be collected through a mobile app.
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Timepoint [1]
338683
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Collected weekly from the time the participant begins intervention in the pre-catheter phase (for the duration of the 30-90 day phase), stops when they've had the peritoneal dialysis catheter inserted and begun treatment, Re-commences when the participant starts the post-catheter phase intervention (weekly for 8 weeks).
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Primary outcome [2]
338684
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Feasibility - Adverse Events
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Assessment method [2]
338684
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Participants will be asked weekly to report any adverse events they had experienced through a study made question. Adverse events are defined as any adverse change in health status or side effect during or as a result of the intervention. The adverse event questioning will capture the event specifics (event type, caused by), if it affected the participants ability to complete the session and subsequent usual activities and, any treatment required. This data will be collected weekly through a mobile app.
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Timepoint [2]
338684
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Collected weekly from the time the participant begins intervention in the pre-catheter phase (for the duration of the 30-90 day phase), stops when they've had the peritoneal dialysis catheter inserted and begun treatment, Re-commences when the participant starts the post-catheter phase intervention (weekly for 8 weeks).
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Primary outcome [3]
338685
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Feasibility - Participant Satisfaction
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Assessment method [3]
338685
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Participants in the intervention group will be asked to complete a study-made survey built into the mobile application following completion all the intervention components. The survey includes 12 statements for participants to indicate their level of agreement from “[1] Strongly Disagree” to “[5] Strongly Agree”, one relating to likelihood of recommendation and five open questions. Themes of these questions include perceived health benefit, intervention positives/negatives, likelihood of sustaining the program and suggested improvements.
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Timepoint [3]
338685
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End of the 8-week intervention in the post-catheter phase
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Secondary outcome [1]
437002
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Life-Participation and Independence (this will be assessed as a composite outcome)
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Assessment method [1]
437002
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EQ-5D Instrument
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Timepoint [1]
437002
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At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
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Secondary outcome [2]
437003
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Physical Function
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Assessment method [2]
437003
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Short Physical Performance Battery
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Timepoint [2]
437003
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At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
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Secondary outcome [3]
437004
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Abdominal Muscle Strength
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Assessment method [3]
437004
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Abdominal Flexion Test
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Timepoint [3]
437004
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At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
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Secondary outcome [4]
437005
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Gastrointestinal Symptoms (this will be assessed as a composite outcome)
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Assessment method [4]
437005
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Bristol stool chart and study made single question relating to urgency and frequency of bowel movements over the previous 7-days
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Timepoint [4]
437005
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At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
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Secondary outcome [5]
437006
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Physical Activity
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Assessment method [5]
437006
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Accelerometery (GENEactiv wrist-watch)
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Timepoint [5]
437006
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At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
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Secondary outcome [6]
437007
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Peritoneal Dialysis Infection Rate
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Assessment method [6]
437007
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Data regarding infection, more specifically peritonitis and exit site, are defined as an inflammation of the peritoneum, will be collected via medical records.
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Timepoint [6]
437007
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At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
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Secondary outcome [7]
437008
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Peritoneal Dialysis Technique Failure
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Assessment method [7]
437008
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Data regarding technique failure, defined as any switch from peritoneal dialysis to haemodialysis for 30-days or more, will be collected by medical records.
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Timepoint [7]
437008
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At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
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Eligibility
Key inclusion criteria
- Aged 18 years of age and over
- Enrolled to commence receiving peritoneal dialysis in South Australia but yet to have peritoneal dialysis catheter inserted
- Independently ambulant (including use of aids such as walking stick, crutches, four-wheel walker etc.)
- Able to use a mobile phone
- Able to obtain medical consent from their treating nephrologist
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Unable to give written consent
- Unable to understand or read English
- Known or suspected pregnancy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
14/10/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
316781
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Charities/Societies/Foundations
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Name [1]
316781
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The Hospital Research Foundation - Kidney Transplant Diabetes Research Australia, CNARTS Research Project Grants 2024
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Address [1]
316781
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Country [1]
316781
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Australia
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Primary sponsor type
University
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Name
University of South Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
319083
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Government body
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Name [1]
319083
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Central Adelaide Local Health Network
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Address [1]
319083
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Country [1]
319083
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315549
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
315549
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
315549
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Australia
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Date submitted for ethics approval [1]
315549
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27/05/2024
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Approval date [1]
315549
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29/07/2024
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Ethics approval number [1]
315549
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Ethics committee name [2]
315987
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University of South Australia Human Research Ethics Committee
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Ethics committee address [2]
315987
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https://i.unisa.edu.au/staff/research/research-ethics/human-research-ethics/
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Ethics committee country [2]
315987
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Australia
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Date submitted for ethics approval [2]
315987
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21/08/2024
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Approval date [2]
315987
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23/08/2024
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Ethics approval number [2]
315987
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Summary
Brief summary
The physical function of people commencing peritoneal dialysis is poor as a result of their kidney disease. The choice of receiving peritoneal dialysis requires people to self-manage their treatment which includes being able to set up their home peritoneal dialysis machine, move large bags of dialysate fluid and connect to and disconnect themselves from the machine. Hence, they must maintain sufficient physical function to continue managing their peritoneal dialysis. In this cohort, poor physical function has adverse effects on the core patient outcomes of life participation, independence and peritoneal dialysis technique survival Pre-operative exercise, also termed prehabilitation, is defined as a process of improving the functional capability of a person prior to a surgical procedure. This study will establish the feasibility/acceptability of a prehabilitation-focused exercise program in people commencing peritoneal dialysis. The hypothesis is that by introducing exercise early into the treatment plan, people receiving peritoneal dialysis will be more able to incorporate, and maintain, a safe exercise program to maintain physical function, live well, and remain on peritoneal dialysis longer.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
135050
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Dr Brett Tarca
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Address
135050
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University of South Australia, Allied Health and Human Performance. PO Box 2471, Adelaide, SA, 5001
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Country
135050
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Australia
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Phone
135050
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+61 8 83022906
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Fax
135050
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Email
135050
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[email protected]
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Contact person for public queries
Name
135051
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Brett Tarca
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Address
135051
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University of South Australia, Allied Health and Human Performance. PO Box 2471, Adelaide, SA, 5001
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Country
135051
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Australia
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Phone
135051
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+61 8 83022906
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Fax
135051
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Email
135051
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[email protected]
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Contact person for scientific queries
Name
135052
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Brett Tarca
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Address
135052
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University of South Australia, Allied Health and Human Performance. PO Box 2471, Adelaide, SA, 5001
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Country
135052
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Australia
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Phone
135052
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+61 8 83022906
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Fax
135052
0
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Email
135052
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
Download to PDF