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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
Scientific title
The Effect of a Prehabilitation Exercise Program on Peritoneal Dialysis Outcomes: A Feasibility Study
Secondary ID [1] 312374 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CORE-PD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure 334163 0
Condition category
Condition code
Renal and Urogenital 330834 330834 0 0
Kidney disease
Physical Medicine / Rehabilitation 331436 331436 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328870 0
Lifestyle
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.
Control group
Active

Outcomes
Primary outcome [1] 338683 0
Feasibility - Adherence
Timepoint [1] 338683 0
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).
Primary outcome [2] 338684 0
Feasibility - Adverse Events
Timepoint [2] 338684 0
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).
Primary outcome [3] 338685 0
Feasibility - Participant Satisfaction
Timepoint [3] 338685 0
End of the 8-week intervention in the post-catheter phase
Secondary outcome [1] 437002 0
Life-Participation and Independence (this will be assessed as a composite outcome)
Timepoint [1] 437002 0
At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
Secondary outcome [2] 437003 0
Physical Function
Timepoint [2] 437003 0
At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
Secondary outcome [3] 437004 0
Abdominal Muscle Strength
Timepoint [3] 437004 0
At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
Secondary outcome [4] 437005 0
Gastrointestinal Symptoms (this will be assessed as a composite outcome)
Timepoint [4] 437005 0
At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
Secondary outcome [5] 437006 0
Physical Activity
Timepoint [5] 437006 0
At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
Secondary outcome [6] 437007 0
Peritoneal Dialysis Infection Rate
Timepoint [6] 437007 0
At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)
Secondary outcome [7] 437008 0
Peritoneal Dialysis Technique Failure
Timepoint [7] 437008 0
At baseline (pre-catheter phase), re-commencement of intervention (post-catheter phase), completion of 8-week post-catheter intervention (post-catheter phase)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to give written consent
- Unable to understand or read English
- Known or suspected pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316781 0
Charities/Societies/Foundations
Name [1] 316781 0
The Hospital Research Foundation - Kidney Transplant Diabetes Research Australia, CNARTS Research Project Grants 2024
Country [1] 316781 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 319083 0
Government body
Name [1] 319083 0
Central Adelaide Local Health Network
Address [1] 319083 0
Country [1] 319083 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315549 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 315549 0
Ethics committee country [1] 315549 0
Australia
Date submitted for ethics approval [1] 315549 0
27/05/2024
Approval date [1] 315549 0
29/07/2024
Ethics approval number [1] 315549 0
Ethics committee name [2] 315987 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 315987 0
Ethics committee country [2] 315987 0
Australia
Date submitted for ethics approval [2] 315987 0
21/08/2024
Approval date [2] 315987 0
23/08/2024
Ethics approval number [2] 315987 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135050 0
Dr Brett Tarca
Address 135050 0
University of South Australia, Allied Health and Human Performance. PO Box 2471, Adelaide, SA, 5001
Country 135050 0
Australia
Phone 135050 0
+61 8 83022906
Fax 135050 0
Email 135050 0
brett.tarca@unisa.edu.au
Contact person for public queries
Name 135051 0
Brett Tarca
Address 135051 0
University of South Australia, Allied Health and Human Performance. PO Box 2471, Adelaide, SA, 5001
Country 135051 0
Australia
Phone 135051 0
+61 8 83022906
Fax 135051 0
Email 135051 0
brett.tarca@unisa.edu.au
Contact person for scientific queries
Name 135052 0
Brett Tarca
Address 135052 0
University of South Australia, Allied Health and Human Performance. PO Box 2471, Adelaide, SA, 5001
Country 135052 0
Australia
Phone 135052 0
+61 8 83022906
Fax 135052 0
Email 135052 0
brett.tarca@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.