Trial Review

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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.
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)
Secondary ID [1] 311214 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Prehab-Fit
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopaenia 332403 0
Frailty 332404 0
Malnutrition 332591 0
Condition category
Condition code
Musculoskeletal 329104 329104 0 0
Other muscular and skeletal disorders
Diet and Nutrition 329105 329105 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 327672 0
Treatment: Other
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).
Control group
Active

Outcomes
Primary outcome [1] 336922 0
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
Timepoint [1] 336922 0
Preoperatively - Completion of a digital patient health questionnaire occurs upon completion of a request for elective admission (REA) for surgery being completed
Primary outcome [2] 337184 0
Recruitment
Timepoint [2] 337184 0
Preoperatively as patients are added to the surgical wait list and consent to study - within 3-6 months prior to planned surgical date.
Primary outcome [3] 337185 0
Participation
Timepoint [3] 337185 0
12 weeks post intervention commencement
Secondary outcome [1] 430172 0
To determine if the prehabilitation program is acceptable to patients and is easy to use
Timepoint [1] 430172 0
administered on completion of the prehabilitation program at week 12.
Secondary outcome [2] 430173 0
Sarcopaenia - Grip strength
Timepoint [2] 430173 0
Preoperative assessments: baseline, week 12 post intervention commencement
Secondary outcome [3] 430174 0
Nutritional assessment
Timepoint [3] 430174 0
Preoperative assessments: baseline, week 12 post intervention commencement
Secondary outcome [4] 431002 0
Smoking Cessation
Timepoint [4] 431002 0
Preoperative assessments: baseline, week 12 post intervention commencement
Secondary outcome [5] 431041 0
Assess feasibility Patient Reported Outcome Measures (PROMS)
Timepoint [5] 431041 0
Preoperative Assessment: baseline
Postoperative Assessment: day 3, day 30
Secondary outcome [6] 431042 0
Projected and actual hospital length of stay (LOS)
Timepoint [6] 431042 0
Postoperative assessment: patient discharge
Secondary outcome [7] 431043 0
Hospital Acquired Complications (HAC)
Timepoint [7] 431043 0
Postoperative assessment: 30 days
Secondary outcome [8] 431625 0
Sarcopaenia - leg strength and endurance
Timepoint [8] 431625 0
Preoperative assessments: baseline, week 12 post intervention commencement
Secondary outcome [9] 431626 0
Sarcopaenia - assess mobility
Timepoint [9] 431626 0
Preoperative assessments: baseline, week 12 post intervention commencement
Secondary outcome [10] 431627 0
Sarcopaenia - changes in mobility
Timepoint [10] 431627 0
Preoperative assessments: baseline, week 12 post intervention commencement
Secondary outcome [11] 431629 0
Nutrition - Lean Muscle Mass
Timepoint [11] 431629 0
Preoperative assessments: baseline, week 12 post intervention commencement
Secondary outcome [12] 431630 0
Nutrition - Weight
Timepoint [12] 431630 0
Preoperative assessments: baseline, week 12 post intervention commencement
Secondary outcome [13] 431631 0
Assess feasibility Patient Reported Outcome Measures (PROMS)
Timepoint [13] 431631 0
Postoperative assessment: day 30

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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/02/2024
Actual
6/03/2024
Date of last participant enrolment
Anticipated
16/02/2025
Actual
Date of last data collection
Anticipated
16/03/2025
Actual
Sample size
Target
50
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25954 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 41789 0
3165 - Bentleigh East

Funding & Sponsors
Funding source category [1] 315473 0
Hospital
Name [1] 315473 0
Monash Health
Country [1] 315473 0
Australia
Funding source category [2] 315474 0
Other
Name [2] 315474 0
Australian and New Zealand College of Anaesthetists
Country [2] 315474 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Rd Clayton, Victoria, 3168
Country
Australia
Secondary sponsor category [1] 317544 0
Other
Name [1] 317544 0
ANZCA Clinical Trials Network
Address [1] 317544 0
630 St Kilda Rd Melbourne, Victoria, 3004
Country [1] 317544 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314383 0
Monash Health Human Research Ethics Committee B
Ethics committee address [1] 314383 0
246 Clayton Rd. Clayton, Victoria, 3168
Ethics committee country [1] 314383 0
Australia
Date submitted for ethics approval [1] 314383 0
21/11/2023
Approval date [1] 314383 0
17/01/2024
Ethics approval number [1] 314383 0

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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131382 0
Dr Belinda Phillips
Address 131382 0
Monash Health, 246 Clayton Rd. Clayton, Victoria, 3168
Country 131382 0
Australia
Phone 131382 0
+61 421701823
Fax 131382 0
Email 131382 0
belinda.phillips@monashhealth.org
Contact person for public queries
Name 131383 0
Ms Margaret Quayle
Address 131383 0
Monash Health, 823-865 Centre Rd. Bentleigh East, Victoria, 3165
Country 131383 0
Australia
Phone 131383 0
+61 409355664
Fax 131383 0
Email 131383 0
margaret.quayle@monashhealth.org
Contact person for scientific queries
Name 131384 0
Dr Belinda Phillips
Address 131384 0
Monash Health, 246 Clayton Rd. Clayton, Victoria, 3168
Country 131384 0
Australia
Phone 131384 0
+61 421701823
Fax 131384 0
Email 131384 0
belinda.phillips@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data collected will be deidentified and group data will be reported in a journal publication


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.