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Trial registered on ANZCTR
Registration number
ACTRN12624000138583
Ethics application status
Approved
Date submitted
19/12/2023
Date registered
14/02/2024
Date last updated
4/06/2024
Date data sharing statement initially provided
14/02/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A study to test the feasibility for adding a home-based Prehabilitation program prior to having total hip or knee surgery in older patients.
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Scientific title
A pilot randomised controlled trial for a digitally-driven, home-based Prehabilitation program in Frail, elderly patients undergoing lower limb joint arthroplasty (Prehab-Fit)
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Secondary ID [1]
311214
0
Nil Known
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Universal Trial Number (UTN)
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Trial acronym
Prehab-Fit
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sarcopaenia
332403
0
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Frailty
332404
0
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Malnutrition
332591
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Condition category
Condition code
Musculoskeletal
329104
329104
0
0
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Other muscular and skeletal disorders
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Diet and Nutrition
329105
329105
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Standard preoperative care plus prehabilitation is defined as:
1. Delivery of standard preoperative care
2. Face-to-face (FTF) review within 3-6 months of planned surgery, to confirm and assess:
a. Sarcopaenia: grip strength, 30 second sit-to-stand (STS), timed-up-and-go (TUG), and the de Morton Mobility Index (DEMMI)
b. Nutrition screening via malnutrition screening tool (MST). If screen positive, further malnutrition classification using the 7-point Subjective Global Assessment (SGA), lean muscle mass, body mass index (BMI_ and serum albumin and transthyretin levels
c. Smoking status Y/N. If screen positive, further smoking classification using the Heaviness of Smoking Index (HSI).
3. Intervention is dependent on the above findings:
a. All patients will undergo a targeted sarcopaenia program. This program will be delivered individually. This consists of an initial 60 minute FTF physiotherapy review. The patient will be assessed by the physiotherapist using the revised BORG RPE (Borg rating of perceived exertion) scale aiming for an exercise intensity of 3 (moderate) and allocated to 2x ability-adjusted exercise programs focusing on cardiovascular and strength exercises. Patients will complete 4 x 30 minute sessions per week. Some of the exercises in the cardiovascular program include getting in and out of bed, walking, marching on the spot, punching the air and steps ups. Some of the exercises in the strength program include heel raises, knee extensions, hip flexion, shoulder press, bicep curls and upright row. Education on safe completion of the program, progression through the program and measurement of adherence via mobile phone app is provided during this session. The app being used has been designed specifically for this study and is called "Monash Prehab".
b. The exercise program will continue via a tele-health supported, home-based exercise program over the course of 12 weeks with 3x telehealth delivered physiotherapy sessions at weeks 2, 4, 8. The sessions will assess adherence to the program, ongoing education as required, progression of exercises as required and sessions 15-30 minutes in duration.
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Intervention code [1]
327672
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Treatment: Other
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Comparator / control treatment
Standard preoperative care is defined as:
• Completion of a digital patient health questionnaire occurs upon completion of a request for elective admission (REA) for surgery. The remaining assessments occur within 3-6 months prior to planned surgical date.
• Triage by orthopaedic perioperative liaison nurses (PLNs),
• Standard preadmission clinic review with surgeon, anaesthetist, pharmacist and nurse within 4 weeks of planned surgical date,
• Standard investigations include a 12 lead electrocardiogram (ECG) (within 1 year of surgery), baseline pathology (full blood count, renal function, anaemia screening, haemoglobin A1C (HbA1C) if diabetic).
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Control group
Active
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Outcomes
Primary outcome [1]
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i. To assess whether a digitally-driven, home-based prehabilitation program is feasible for frail patients > 65 years of age undergoing major lower limb joint arthroplasty
Feasibility is assessed by rate of eligible participants
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Assessment method [1]
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Preliminary interrogation of the Monash Health waiting list for planned joint arthroplasty / those identified in patient medical record as frail
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Timepoint [1]
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Preoperatively - Completion of a digital patient health questionnaire occurs upon completion of a request for elective admission (REA) for surgery being completed
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Primary outcome [2]
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Recruitment
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Assessment method [2]
337184
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Percentage of eligible patients that consented to participate in study trial will be assessed by medical record review and study records
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Timepoint [2]
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Preoperatively as patients are added to the surgical wait list and consent to study - within 3-6 months prior to planned surgical date.
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Primary outcome [3]
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Participation
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Assessment method [3]
337185
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Percentage of all recruited patients completing >75% of prescribed prehabilitation components will be assessed by app adherence records.
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Timepoint [3]
337185
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12 weeks post intervention commencement
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Secondary outcome [1]
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To determine if the prehabilitation program is acceptable to patients and is easy to use
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Assessment method [1]
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measured by a patient reported experience measure (PREM) questionnaire. This questionnaire has been designed specifically for the study.
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Timepoint [1]
430172
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administered on completion of the prehabilitation program at week 12.
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Secondary outcome [2]
430173
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Sarcopaenia - Grip strength
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Assessment method [2]
430173
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Assessing grip strength using hand dynamometer in kg
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Timepoint [2]
430173
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Preoperative assessments: baseline, week 12 post intervention commencement
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Secondary outcome [3]
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Nutritional assessment
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Assessment method [3]
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7-point Subjective Global Assessment (SGA) - Scale 1-7 with:
1 = well nourished
7 = severely malnourished
serum albumin and transthyretin levels
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Timepoint [3]
430174
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Preoperative assessments: baseline, week 12 post intervention commencement
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Secondary outcome [4]
431002
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Smoking Cessation
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Assessment method [4]
431002
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Assessing smoking cessation through the heaviness of smoking index (HSI) and carbon monoxide CO monitoring. CO will be monitored by measuring exhaled CO levels using the Picobaby Smokerlyzer Bedfront 4519.
Whereby <8ppm is considered confirmation of non smoking status
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Timepoint [4]
431002
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Preoperative assessments: baseline, week 12 post intervention commencement
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Secondary outcome [5]
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Assess feasibility Patient Reported Outcome Measures (PROMS)
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Assessment method [5]
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Completion of Quality of Recovery -15 (QoR15) - patient questionnaire ,
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Timepoint [5]
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Preoperative Assessment: baseline
Postoperative Assessment: day 3, day 30
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Secondary outcome [6]
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Projected and actual hospital length of stay (LOS)
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Assessment method [6]
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Medical record review
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Timepoint [6]
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Postoperative assessment: patient discharge
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Secondary outcome [7]
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Hospital Acquired Complications (HAC)
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Assessment method [7]
431043
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death, cardiovascular, respiratory, surgical site infection (SSI) /sepsis, delirium, other. This will be determined through medical record review and patient reported outcomes during 30 day patient follow up.
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Timepoint [7]
431043
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Postoperative assessment: 30 days
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Secondary outcome [8]
431625
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Sarcopaenia - leg strength and endurance
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Assessment method [8]
431625
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30 second sit to stand (STS) - number of stands in 30 seconds
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Timepoint [8]
431625
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Preoperative assessments: baseline, week 12 post intervention commencement
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Secondary outcome [9]
431626
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Sarcopaenia - assess mobility
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Assessment method [9]
431626
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Timed Up and Go (TUG) - time in seconds
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Timepoint [9]
431626
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Preoperative assessments: baseline, week 12 post intervention commencement
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Secondary outcome [10]
431627
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Sarcopaenia - changes in mobility
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Assessment method [10]
431627
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De Morton Mobility Index (DEMMI) - Score 1-100
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Timepoint [10]
431627
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Preoperative assessments: baseline, week 12 post intervention commencement
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Secondary outcome [11]
431629
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Nutrition - Lean Muscle Mass
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Assessment method [11]
431629
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Mid arm muscle circumference in cm
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Timepoint [11]
431629
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Preoperative assessments: baseline, week 12 post intervention commencement
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Secondary outcome [12]
431630
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Nutrition - Weight
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Assessment method [12]
431630
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Digital Scales and Body Mass Index (BMI) calculation
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Timepoint [12]
431630
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Preoperative assessments: baseline, week 12 post intervention commencement
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Secondary outcome [13]
431631
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Assess feasibility Patient Reported Outcome Measures (PROMS)
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Assessment method [13]
431631
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Days Alive at Home (DAH30) assessed by patient medical record review and 30 day phone follow up
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Timepoint [13]
431631
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Postoperative assessment: day 30
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Eligibility
Key inclusion criteria
• Patients > 65 years of age, any gender
• Screen positive for frailty (FRAIL scale)
• Planned for elective unilateral hip or knee arthroplasty within 3-6 months
• Able to access and operate a mobile phone
• Able to participate successfully in a home-based exercise program
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Minimum age
65
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
• Bilateral or redo procedures
• Any condition or circumstances preventing accurate completion of prehabilitation programs such as psychological, social, physical or technological. This does not automatically exclude cultural and linguistically diverse (CALD) patients and interpreter services will be employed to ensure capture of this important demographic.
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Study design
Purpose of the study
Prevention
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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)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
This is a pilot study assessing feasibility in a two armed trial. It is reasonable to apply published “rules of thumb” as a determination of appropriate sample size. As such, a sample size of 50 patients in total, or 25 patients in the sarcopaenia intervention and 25 patients in the control group, will give sufficient precision in adherence rates and outcome rates for the design of a future definitive trial. Sample sizes for both the nutritional and smoking cessation pathways will be lower and as such, data gathered in these interventions will be exploratory.
Data will be analysed using SPSS for Windows version 29 (SPSS Australasia Ltd. Sydney).
Demographic and perioperative data will be presented as mean (SD) or number (%) for categorical variables, or median and interquartile ranges (IQRs) for continuous variables.
Associations will be analysed using Spearman rank correlation and a p-value of <0.05 will be considered significant.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
16/02/2024
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Actual
6/03/2024
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Date of last participant enrolment
Anticipated
16/02/2025
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Actual
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Date of last data collection
Anticipated
16/03/2025
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Actual
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Sample size
Target
50
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Accrual to date
10
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
25954
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Monash Medical Centre - Moorabbin campus - East Bentleigh
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Recruitment postcode(s) [1]
41789
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3165 - Bentleigh East
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Funding & Sponsors
Funding source category [1]
315473
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Hospital
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Name [1]
315473
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Monash Health
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Address [1]
315473
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246 Clayton Rd Clayton, Victoria, 3168
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Country [1]
315473
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Australia
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Funding source category [2]
315474
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Other
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Name [2]
315474
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Australian and New Zealand College of Anaesthetists
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Address [2]
315474
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630 St Kilda Rd Melbourne, Victoria, 3004
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Country [2]
315474
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Australia
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Primary sponsor type
Hospital
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Name
Monash Health
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Address
246 Clayton Rd Clayton, Victoria, 3168
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Country
Australia
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Secondary sponsor category [1]
317544
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Other
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Name [1]
317544
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ANZCA Clinical Trials Network
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Address [1]
317544
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630 St Kilda Rd Melbourne, Victoria, 3004
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Country [1]
317544
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314383
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Monash Health Human Research Ethics Committee B
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Ethics committee address [1]
314383
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246 Clayton Rd. Clayton, Victoria, 3168
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Ethics committee country [1]
314383
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Australia
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Date submitted for ethics approval [1]
314383
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21/11/2023
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Approval date [1]
314383
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17/01/2024
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Ethics approval number [1]
314383
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Summary
Brief summary
The aim of this study is to address the knowledge gaps relating to prehabilitation in older frail patients having hip or knee surgery, and to explore the opportunities of delivering home-based preoperative care through digital technology. Patients will be randomly allocated to a treatment group. One group will receive standard preoperative care before their surgery. The other group will receive standard care plus the prehabilitation program before their surgery. This study also acts to inform future research in frail patients undergoing these surgeries to optimise post-operative outcomes.
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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
131382
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Dr Belinda Phillips
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Address
131382
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Monash Health, 246 Clayton Rd. Clayton, Victoria, 3168
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Country
131382
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Australia
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Phone
131382
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+61 421701823
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Fax
131382
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Email
131382
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[email protected]
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Contact person for public queries
Name
131383
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Ms Margaret Quayle
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Address
131383
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Monash Health, 823-865 Centre Rd. Bentleigh East, Victoria, 3165
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Country
131383
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Australia
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Phone
131383
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+61 409355664
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Fax
131383
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Email
131383
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[email protected]
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Contact person for scientific queries
Name
131384
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Dr Belinda Phillips
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Address
131384
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Monash Health, 246 Clayton Rd. Clayton, Victoria, 3168
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Country
131384
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Australia
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Phone
131384
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+61 421701823
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Fax
131384
0
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Email
131384
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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
Data collected will be deidentified and group data will be reported in a journal publication
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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.
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