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Trial registered on ANZCTR


Registration number
ACTRN12620001315909
Ethics application status
Approved
Date submitted
2/11/2020
Date registered
7/12/2020
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Modifiable physical factors that predict physical functioning for patients receiving peritoneal dialysis.
Scientific title
Modifiable physical factors that predict physical functioning for patients receiving peritoneal dialysis.
Secondary ID [1] 302677 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with end stage kidney disease receiving peritoneal dialysis 319596 0
Condition category
Condition code
Renal and Urogenital 317535 317535 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
The primary objective is to investigate what modifiable physical factors contribute to physical functioning in patients receiving peritoneal dialysis. This 12 month longitudinal cohort study will assess physical activity levels / sedentary behaviour, muscle strength
and cardiorespiratory fitness as predictors of physical function at three time points (baseline, six months and twelve months) in PD patients.

Each assessment session includes;
- Collection of demographic information (age, height, weight, waist / hip girth, medical history, dialysis history)
- Assessment of physical function via the Short Physical Performance Battery and Short Form 36 Physical Functioning Scale.
- Assessment of maximal isometric muscular strength of bicep strength, quadriceps strength and abdominal strength using a hand-held dynamometer and hand grip strength using a hand-grip dynamometer.
- Assessment of cardiorespiratory fitness via total distance walked during a six-minute walk test

At the conclusion of these assessments, two devices are given to participants to wear from midnight of the following day.
- Assessment of physical activity levels via a GENEActiv Accelerometer that participants wear on their wrist for 7-days
- Assessment of sedentary behaviour levels via a ActivPAL Inclinometer that participants wear on their mid-upper thigh for 7-days
Intervention code [1] 318961 0
Not applicable
Comparator / control treatment
No comparator or control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325576 0
Objective physical function measured via the Short Physical Performance Battery assessing walking speed, standing balance, and sit-to stand performance
Timepoint [1] 325576 0
Baseline, six-months post-baseline and 12-months post baseline
Secondary outcome [1] 388427 0
Self-reported physical function measured via the Short-Form 36 - Physical Functioning Scale instrument
Timepoint [1] 388427 0
Baseline, six-months post-baseline and 12-months post baseline

Eligibility
Key inclusion criteria
1. Over 18 years of age
2. Receiving a form of peritoneal dialysis in South Australia
3. Medical clearance (treating Nephrologist)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to give written consent
2. Unable to understand English or adequate translator services available.
3. Acute event that would deem the participant unsafe for participation (to be determined by nephrologist).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will describe the cohort demographics. Pearson correlation tests will be used to examine the associations between predictor variables and physical functioning at baseline, and to determine two additional confounders to be used in the final model (in addition to the duration on dialysis). Individual linear regression models will be used with the SPPB to identify the strongest single predictor within each category of predictors (muscle strength, and sedentary behaviour / physical activity change scores) to include in the final model. Multivariate linear regression with the three final predictor variables (one muscle strength, one activity and cardiorespiratory fitness) and three confounders (time on dialysis and two others) with physical function as the outcome will be conducted. Removal of predictor variables from the model will illustrate the predictive strengths via the level of variance explained. A conservative power calculation suggests 30% power with a sample size of 60 participants based on a three-predictor and three-confounder model with R2 = 0.15, 5% explained variance per predictor. The PD population in South Australia is approximately 106..

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307117 0
University
Name [1] 307117 0
University of South Australia
Address [1] 307117 0
Corner of North Terrace and, Frome Rd,
Adelaide SA 5001
Country [1] 307117 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] 307689 0
None
Name [1] 307689 0
Address [1] 307689 0
Country [1] 307689 0
Other collaborator category [1] 281526 0
Government body
Name [1] 281526 0
Central Northern Adelaide Renal Transplantation Service - Clinical Research Group
Address [1] 281526 0
Royal Adelaide Hospital
Port Rd, Adelaide SA 5000
Country [1] 281526 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307229 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 307229 0
The Queen Elizabeth Hospital
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 307229 0
Australia
Date submitted for ethics approval [1] 307229 0
16/08/2018
Approval date [1] 307229 0
29/10/2018
Ethics approval number [1] 307229 0
R20180810

Summary
Brief summary
The primary objective is to investigate what modifiable physical factors contribute to physical functioning in patients receiving peritoneal dialysis (PD).
This 12 month longitudinal cohort study will assess physical activity levels / sedentary behaviour, muscle strength and cardiorespiratory fitness as predictors of physical function at three time points (baseline, six months and
twelve months) in PD patients.

Physical activity, sedentary behaviour, muscular strength and cardiorespiratory
fitness have all been demonstrated as modifiable physical factors that can be positively modified through exercise based interventions.

However, to best inform exercise prescription, understanding of the modifiable physical factors that contribute to physical function is required. This research project will be the first to determine the specific modifiable (physical activity and physical impairment) predictors of physical functioning in patients receiving PD. This project could significantly expand knowledge in this field, inform clinical practice and surveillance testing to
improve early risk detection, and lead to future PD-specific exercise based interventions targeting physical functioning, improved quality of life and clinical outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106482 0
Mr Brett Tarca
Address 106482 0
Att: Brett Tarca (P2-42a)
University of South Australia
Reply Paid 2471
Adelaide, SA 5001
Country 106482 0
Australia
Phone 106482 0
+61 8 8302 2906
Fax 106482 0
Email 106482 0
brett.tarca@mymail.unisa.edu.au
Contact person for public queries
Name 106483 0
Mr Brett Tarca
Address 106483 0
Att: Brett Tarca (P2-42a)
University of South Australia
Reply Paid 2471
Adelaide, SA 5001
Country 106483 0
Australia
Phone 106483 0
+61 8 8302 2906
Fax 106483 0
Email 106483 0
brett.tarca@mymail.unisa.edu.au
Contact person for scientific queries
Name 106484 0
Mr Brett Tarca
Address 106484 0
Att: Brett Tarca (P2-42a)
University of South Australia
Reply Paid 2471
Adelaide, SA 5001
Country 106484 0
Australia
Phone 106484 0
+61 8 8302 2906
Fax 106484 0
Email 106484 0
brett.tarca@mymail.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
Participants will be provided with an individual report pertaining to their own scores throughout the 12-month study period. However, our ethics protocol stipulates that no individual data (including de-identified data) will be made available.
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 9596 0
Informed consent form
Citation [1] 9596 0
Link [1] 9596 0
Email [1] 9596 0
Other [1] 9596 0
Summary results
No Results