Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001028594
Ethics application status
Approved
Date submitted
3/08/2024
Date registered
26/08/2024
Date last updated
26/08/2024
Date data sharing statement initially provided
26/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Digital intervention for degenerative meniscal injuries
Scientific title
The efficacy of a digital-based education and exercise intervention for degenerative meniscal injuries awaiting public orthopaedic outpatient assessment: A pilot trial
Secondary ID [1] 312678 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative meniscal injuries 334666 0
Condition category
Condition code
Musculoskeletal 331238 331238 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 – Digital intervention: - Participants in this group will be provided with a digital exercise and education intervention. Participants will be asked to engage in the intervention 5 days per week for 12 weeks.
The exercise and education intervention will be delivered using ‘Physitrack’ patient software. The Physitrack software is accessible for all participants with an internet connection and device (computer/laptop/tablet/smart phone). For the purpose of the study, Physitrack will be the portal used for all exercise, education and outcome measures. Participants will be provided with a login that gives them access to this software. The exercise program is layed out day-by-day and week-by-week with specific instructions, videos of all exercises and key exercise prescription variables included. The participants will be asked to tick off each exercise as they progress to allow the research team to monitor adherence to exercise using the features of the software. The education modules will be uploaded into the software and will be in both short video and written content. These modules are self-guided and can be completed at the particpants own pace. Physitrack has the ability to track completion of these modules for adherence feedback to the research team. Outcome measures when required to be completed are sent to the patient via Physitrack and an alert will be sent to them to be completed. The Physitrack software also has an active messenger service that will link the participant with the research team in the event they have any questions or concerns.
Each participant will be provided with a 30-min telehealth introduction session conducted by a physiotherapist/member of the research team prior to commencement that will include an orientation to the Physitrack software and contact instructions for the research team in the event of any issues or concerns. In this session, no individual condition specific information will be provided.
The intervention will include a home-based strength training program targeting key lower limb musculature 2 days per week and an aerobic exercise program of their choice on 3 days per week. It is anticipated that this exercise program will take 15-30 minutes per session to complete. Examples of lower limb strength-based exercises included sit-to-stand, seated knee extension, double leg bridges and single leg calf raises. Examples of suggested aerobic exercise include walking, riding a bicycle, exercise bike, rowing machine or swimming. Strength-based exercises are aimed to be of moderate intensity and will be measured using a 0-10 RPE scale. Specific participant instructions regarding this are included in the Physitrack software next to each exercise. In addition, each exercise has cues on how to increase or decrease difficulty to assist in meeting the RPE demands. Aerobic exercise intensity is not measured in this study as we are aiming to encourage any form of movement alongside our training program.
In addition, participants will be required to complete patient reported outcome measures at baseline, 12 weeks, and 24 weeks. It is anticipated that the participant commitment at each follow-up point will be approximately 15-20 minutes.



Group 2 - Digital intervention + one-off face to face assessment: - These participants will attend a one-hour face to face assessment session involving detailed clinical assessment of the knee with a senior clinician physiotherapist with 11-28 years experience. In the face to face session patients will be provided with a detailed clinical assessment of their knee, discussion regarding any relevant imaging, education regarding their clinical presentation, surgical vs non-surgical options and the role of education/exercise/lifestyle change in the management of degenerative meniscal injuries. This session will be completed within 2-weeks of commencing the digital-based intervention outlined above. The outcome of the face to face session will not have any bearing on the digital intervention and they will continue to complete the standardised intervention. The purpose of this session is to determine if adding a face to face assessment and reassurance adds an effect above and beyond the intervention outlined for group 1.
Furthermore, each participant will be provided with a 30-min telehealth introduction session prior to commencement that will include an orientation to the Physitrack software and contact instructions for the research team in the event of any issues or concerns. In this session, no individual condition specific information will be provided.
This will be followed by engagement in a digital exercise and education intervention 5 days weekly for 12 weeks delivered using Physitrack patient software per the same protocol as group 1.
Intervention code [1] 329205 0
Rehabilitation
Comparator / control treatment
Group 1 – Digital intervention: - Participants in this group will be provided with a digital exercise and education intervention. Participants will be asked to engage in the intervention 5 days per week for 12 weeks.
The exercise and education intervention will be delivered using ‘Physitrack’ patient software. The software is easily accessible using an electronic device (mobile phone, laptop, computer, tablet) that has internet connection. The software is available via app or browser connection. Each participant will be provided with a 30-min telehealth introduction session conducted by a physiotherapist/member of the research team prior to commencement that will include an orientation to the Physitrack software and contact instructions for the research team in the event of any issues or concerns. In this session, no individual condition specific information will be provided. The software will be used in a number of ways:
-Delivery of education modules via short videos and/or written content depending on patient preference
-Delivery of exercise program including instructions on how to perform, prescription variables and patients will be asked to tick off all exercises when completed so that exercise adherence can be tracked using the software
-Completion of outcome measures using the feature in the app- patients will be alerted when they are required to be completed

The intervention will include a home-based strength training program 2 days per week and an aerobic exercise program of their choice on 3 days per week. The strength training program incorporates 5 different exercises across 3 different levels targeting key lower limb musculature aimed to be completed at a moderate intensity. Intensity is measured using the RPE scale with participants provided with exercise options to increase or decrease intensity of each exercise. Participants will work through each level for 4 weeks. Examples of level 1 exercises include seated knee extension, standing hip abduction, sit to stand, double leg bridge and double leg heel raises. Intensity guidelines for aerobic exercise are not provided and participants are encouraged to perform in any form of aerobic exercise at a self-selected intensity/ It is anticipated that this exercise program will take 15-30 minutes per session to complete.

In addition, they will be required to complete patient reported outcome measures at baseline, 12 weeks, and 24 weeks. It is anticipated that the participant commitment at each follow-up point will be approximately 15-20 minutes.



Group 2 - Digital intervention + one-off face to face assessment: - These participants will attend a one-hour face to face assessment session involving detailed clinical assessment of the knee with a physiotherapist with 11-28 years experience. In the face to face session patients will be provided with a detailed clinical assessment of their knee, discussion regarding any relevant imaging, education regarding their clinical presentation, surgical vs non-surgical options and the role of education/exercise/lifestyle change in the management of degenerative meniscal injuries. The purpose of this session is to determine if individualised assessment, education and reassurance provides any benefit over being directed straight to the digital based intervention. No individualisation of the digital intervention will occur as a result of this session. This session will occur within 2-weeks of commencing participation in the digital education and exercise intervention.
Furthermore, each participant will be provided with a 30-min telehealth introduction session with a physiotherapist/member of the research team prior to commencement that will include an orientation to the Physitrack software and contact instructions for the research team in the event of any issues or concerns. In this session, no individual condition specific information will be provided.
This will be followed by engagement in a digital exercise and education intervention 5 days weekly for 12 weeks delivered using Physitrack patient software as per the outlined protocol for group 1 - see above.
Control group
Active

Outcomes
Primary outcome [1] 339012 0
Knee-related pain
Timepoint [1] 339012 0
Baseline, Following conclusion of intervention (12 weeks), and 12 weeks following the conclusion of the intervention (24 weeks)
Primary outcome [2] 339083 0
Knee-related disability
Timepoint [2] 339083 0
Baseline, Following conclusion of intervention (12 weeks), and 12 weeks following the conclusion of the intervention (24 weeks)
Primary outcome [3] 339084 0
quality of life
Timepoint [3] 339084 0
Baseline, Following conclusion of intervention (12 weeks), and 12 weeks following the conclusion of the intervention (24 weeks)
Secondary outcome [1] 438269 0
Subjective change in health status
Timepoint [1] 438269 0
Following conclusion of intervention (12 weeks), and 12 weeks following the conclusion of the intervention (24 weeks)
Secondary outcome [2] 438270 0
Health-related quality of life
Timepoint [2] 438270 0
Baseline, Following conclusion of intervention (12 weeks), and 12 weeks following the conclusion of the intervention (24 weeks)
Secondary outcome [3] 438271 0
Knee-related pain
Timepoint [3] 438271 0
Baseline, Following conclusion of intervention (12 weeks), and 12 weeks following the conclusion of the intervention (24 weeks)

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion if they:
-aged 40-60 years,
-have unilateral (one-sided) knee pain
-have an MRI confirmed degenerative meniscal pathology.
Minimum age
40 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from this trial if they have:
-a locked knee indicating possible displaced bucket-handle tear
-an associated knee injuring including ligamentous injuries
-had ipsilateral (same sided) knee surgery in the past 2 years
-co-morbidities affecting ability to participate in an exercise program (this will be determined by the research team at screening)
-clinical or radiological evidence of osteoarthritis (Kellgren-Lawrence scale more than or equal to 2) (this will be determined by the research team at screening)

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)
Allocation will be concealed using sequentially numbered, sealed opaque envelopes by research staff not involved in randomisation schedule development or statistical analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be completed using a computer-generated randomisation sequence to develop permuted blocks of variable size. A researcher not involved in participant allocation will be responsible for generating the randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A minimum of 12 to 35 subjects per group is advised for pilot studies (Julious, 2005). Small sample sizes are recommended for simple calculations, which fit the main objective of this study of investigating the usability and preliminary effectiveness of a digital intervention program for degenerative meniscal injuries. The sample size chosen for this pilot study has been set at 60 subjects. To account for an estimated dropout rate of 10% at 24-weeks, a total of 66 participants will be recruited (22 in each group).

Participant withdrawal has been factored into sample size recruitment with a 10% lost to follow up expected. Data for participants withdrawing/lost to follow up will be treated following an intention to treat principle using a last observation carried forward method.

Data will be analysed using SPSS (IBM, New York, NY, USA). The demographic characteristics of the subjects in all groups will be described. Differences in these variables between the intervention and control groups will be analysed using either the Chi-square test or the T test. To compare differences in outcomes measures a series of one-way ANCOVAs (analysis of covariance) will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2024
Actual
Date of last participant enrolment
Anticipated
15/10/2024
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26896 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [2] 26897 0
Bendigo Health Care Group - Anne Caudle campus - Bendigo
Recruitment postcode(s) [1] 42956 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 317112 0
University
Name [1] 317112 0
Melbourne University - Innovation Acceleration Program
Country [1] 317112 0
Australia
Primary sponsor type
Hospital
Name
Bendigo Health
Address
Country
Australia
Secondary sponsor category [1] 319371 0
None
Name [1] 319371 0
Address [1] 319371 0
Country [1] 319371 0
Other collaborator category [1] 283125 0
Individual
Name [1] 283125 0
Dr. Stephen Barrett
Address [1] 283125 0
Country [1] 283125 0
Australia
Other collaborator category [2] 283126 0
Individual
Name [2] 283126 0
Dr. Josh Naunton
Address [2] 283126 0
Country [2] 283126 0
Australia
Other collaborator category [3] 283127 0
Individual
Name [3] 283127 0
Mr. Theo Kapakoulakis
Address [3] 283127 0
Country [3] 283127 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315865 0
Bendigo Health Human Research Ethics Committee
Ethics committee address [1] 315865 0
Ethics committee country [1] 315865 0
Australia
Date submitted for ethics approval [1] 315865 0
18/05/2024
Approval date [1] 315865 0
31/07/2024
Ethics approval number [1] 315865 0
LNR24BH108778

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

Contacts
Principal investigator
Name 136022 0
Mr Ryan Evans
Address 136022 0
Bendigo Health - 100 Mercy Street Bendigo VIC 3550
Country 136022 0
Australia
Phone 136022 0
+61 468648914
Fax 136022 0
Email 136022 0
[email protected]
Contact person for public queries
Name 136023 0
Ryan Evans
Address 136023 0
Bendigo Health - 100 Mercy Street Bendigo VIC 3550
Country 136023 0
Australia
Phone 136023 0
+61 468648914
Fax 136023 0
Email 136023 0
[email protected]
Contact person for scientific queries
Name 136024 0
Ryan Evans
Address 136024 0
Bendigo Health - 100 Mercy Street Bendigo VIC 3550
Country 136024 0
Australia
Phone 136024 0
+61 468648914
Fax 136024 0
Email 136024 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified raw data including patient characteristics and all outcome meaures
When will data be available (start and end dates)?
Immediately following publication with no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by principal investigator - [email protected]; +61468648914


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.