Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000502538
Ethics application status
Approved
Date submitted
12/01/2024
Date registered
23/04/2024
Date last updated
23/04/2024
Date data sharing statement initially provided
23/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Online-delivered education, exercise and anti-inflammatory eating program to people with patellofemoral pain: A single-arm feasibility trial
Scientific title
Online-delivered education, exercise and anti-inflammatory eating program to people with patellofemoral pain: A single-arm feasibility trial
Secondary ID [1] 310385 0
None
Universal Trial Number (UTN)
U1111-1296-9077
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral pain 331129 0
Condition category
Condition code
Musculoskeletal 327913 327913 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 329578 329578 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered online through 1:1 consultation led by a licensed Physiotherapist and a licensed Dietitian. After the individual consultations, participants will gain access to online platforms to support their education, exercise and dietary plan.

Education and exercise therapy

Participants will attend a 60-minute online consultation (Zoom®) with a Physiotherapist.
This 1:1 consultation will include a patient-centred history and information focused on the benign nature of patellofemoral pain, including the explanation of the lack of relationship between knee structural features in imaging exams or knee crepitus with clinical symptoms. Patellofemoral pain will not be referred to as an injury. The importance of actively engaging in an evidence-based exercise program and load management will be emphasised. Participants will be advised to gradually increase physical activity participation to avoid exacerbation of knee pain following the envelope of function model. Strategies to improve self-management will be discussed, and the Physiotherapist will guide the participants on how to best use the ‘My Knee Cap’ online platform for 12 weeks, including prescribing an exercise program customisable through the online platform .

Physical Exercise Goals: During the 1:1 online consultation with the physiotherapist, the exercise goal will be explored, and it will be tailored accordingly to each participant’s previous exercise and sports experience personal goals.
The website “My Knee Cap” has a progression of six different levels for each exercise group (CORE exercises, bridge exercises, hip exercises, quadriceps exercises). Participants will be instructed to progress according to their symptoms. The physiotherapist will provide five tips for them to self-assess their pain and progress to the next level:
1. Ideally keep pain <2/10 during your activities if possible
2. Do not exceed 5/10 pain during exercise
3. Pain should return to normal levels 60 minutes post-exercise
4. Pain should not be increased the following morning post-exercise
5. Do your physical activities based on your pain response.
Participants will be instructed to perform the exercises 2-3x week, and at each day they will follow those tips to progress or regress the level of their exercise.

Strategy to self-managed:
Participants will be advised about load management during their exercises and during daily activities; the five tips described above also fit in the strategy to self-manage their symptoms.

Exercise program prescribed:
The “My Knee Cap” website will provide four groups of exercises: CORE, bridge, hip and quadriceps exercises.
Participants will be instructed to progress in levels according to their symptoms. We will provide five tips for them to self-assess their pain and progress to the next level:
1. Ideally keep pain <2/10 during your activities if possible
2. Do not exceed 5/10 pain during exercise
3. Pain should return to normal levels 60 minutes post-exercise
4. Pain should not be increased the following morning post-exercise
5. Do your physical activities based on your pain response.

CORE:
Level 1 - Bench plank - 3 x 60 seconds - resting 60 seconds between sets
Level 2 - Bench plank inclined decreased - 3 x 60 seconds - resting 60 seconds between sets
Level 3 - Elbow plank - 3 x 60 seconds - resting 60 seconds between sets
Level 4 - Hands plank - 3 x 60 seconds - resting 60 seconds between sets
Level 5 - One-legged plank - 3 x 60 seconds - resting 60 seconds between sets
Level 6 - Side plank - 3 x 60 seconds - resting 60 seconds between sets

Bridge exercises:
Level 1 - Two-legged bridging - 3 x 12 repetitions - resting 60 seconds between sets
Level 2 - Two-legged bridging (increased speed) - 3 x 12 repetitions - resting 60 seconds between sets
Level 3 - Weighted two-legged bridging - 3 x 12 repetitions - resting 60 seconds between sets
Level 4 - One-legged bridging - 3 x 12 repetitions - resting 60 seconds between sets
Level 5 - One-legged bridging (increased speed) - 3 x 12 repetitions - resting 60 seconds between sets
Level 6 - Weighted one-legged bridging - 3 x 12 repetitions - resting 60 seconds between sets

Hip exercises:
Level 1 - Side leg lifts - 3 x 12 repetitions - resting 60 seconds between sets
Level 2 - Side leg lifts (resisted) - 3 x 12 repetitions - resting 60 seconds between sets
Level 3 - Standing leg lifts - 3 x 12 repetitions - resting 60 seconds between sets
Level 4 - Standing leg lifts (hands off support) - 3 x 12 repetitions - resting 60 seconds between sets
Level 5 - Standing leg lifts (gym-based machine) - 3 x 12 repetitions - resting 60 seconds between sets
Level 6 - Powerful standing leg lifts - 3 x 12 repetitions - resting 60 seconds between sets

Quadriceps exercises:
Level 1 - Wall-sit - 3 x 60 seconds - resting 60 seconds between sets
Level 2 - Wall-sit (increased depth) - 3 x 60 seconds - resting 60 seconds between sets
Level 3 - Two-legged squats - 3 x 12 repetitions - resting 60 seconds between sets
Level 4 - Weighted two-legged squats - 3 x 12 repetitions - resting 60 seconds between sets
Level 5 - One-legged squats - 3 x 12 repetitions - resting 60 seconds between sets
Level 6 - Weighted one-legged squats - 3 x 12 repetitions - resting 60 seconds between sets

Monitoring the adherence will be done with weekly emails asking, “How many days did you complete your exercises last week?”



‘My Knee Cap’ has been co-designed with patients and health professionals, and tested by our research team, and provides education to people with patellofemoral pain through four main sections (i) understanding your pain, (ii) treatment options, (iii) exercise program, and (iv) patient stories. All information on the platform is provided in plain language, with multimedia resources such as infographics, animated videos, and podcasts, to facilitate engagement and understanding.
Participants will be advised to complete the exercise program from the website 2-3x a week. They can access the website at any time they desire for information about the exercises program, prognosis, other types of treatments


Anti-inflammatory diet
Participants will attend a 60-minute online appointment (Zoom®) with an Accredited Practicing Dietitian. On this 1:1 appointment, using a shared decision-making model the Dietitian will prescrib a tailored anti-inflammatory food program considering the participants’ socioeconomic condition and personal preferences. The Dietitian will also provid a comprehensive explanation of the anti-inflammatory eating pattern and its benefits and addressed questions and/or concerns.
In general, participants will be advised to follow a food program containing minimally processed foods, higher amounts of whole foods and “good” fats. Examples of whole foods (moderate amounts): lean meats, eggs, and dairy; (higher amounts): fish, fruit, vegetables, nuts, and seeds. “Good fats” will include monounsaturated fats with a favourable omega-6:omega-3 ratio, such as fish, seeds, and olive oil. Participants will be advised to limit highly-processed and refined foods, such as refined carbohydrates (pasta, bread, rice), confectionary, and processed meats. Participants will not be encouraged to follow an energy-restricted diet and were advised to eat to satiety. This food program is based on the recommendations of Cooper et al. (An anti-inflammatory diet intervention for knee osteoarthritis: a feasibility study. BMC Musculoskelet Disord 23, 47 (2022)).
This appointment will be supported by a 12-week subscription to the Total Wellbeing Diet (CSIRO) online platform. In this platform, participants will be able to self-customise their anti-inflammatory food program every week and register whether they had compliance with their plan. The Dietitian will provide initial guidance on how to use the platform and assist with realistic and beneficial goal setting, including shopping and meal planning, navigating social events and eating out, and cooking tips (cooking in a budget and time constraints).

Tailored food program and how the food program will be tailored:
Participants will fill out a 3-day food diary prior to dietitian consultation. The dietitian will analyse the document and discuss with the participants the potential inflammatory food they may take and modify it when possible based on participant's personal preferences, food restrictions and routine.
Intervention code [1] 326789 0
Rehabilitation
Intervention code [2] 326790 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335764 0
Recruitment - The number of participants recruited per month.
Data will be collected from study records,
Timepoint [1] 335764 0
It will be analysed 7 months after the first recruited participant.
Primary outcome [2] 335765 0
Retention Rate - The percentage of participants enrolled in the trial and completed the 12-week follow-up assessment.
Data will be collected from study records.
Timepoint [2] 335765 0
It will be analysed 10 months after the first recruited participant.
Primary outcome [3] 335766 0
Adherence to the exercise-therapy and anti-inflammatory food program
Adherence will be assessed with an 11-point numerical rating scale. The participants will be asked to answer the following questions:

On a scale of 0 to 10, where 0 represents “I did not follow at all” and 10 represents “I strictly followed the program”
(i) How do you feel you followed your exercise-therapy program over the course of the trial?
(ii) How do you feel you followed your eating program over the course of the trial?
 
Timepoint [3] 335766 0
It will be analysed 12 weeks post-commencement of intervention.
Secondary outcome [1] 425506 0
Anterior Knee Pain Scale (AKPS)
Timepoint [1] 425506 0
It will be analysed 12 weeks post-commencement of intervention.
Secondary outcome [2] 425533 0
Knee pain intensity will be assessed with a numerical rating scale.
Timepoint [2] 425533 0
It will be analysed 12 weeks post-commencement of intervention.
Secondary outcome [3] 425534 0
Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QoL) subscale.
Timepoint [3] 425534 0
It will be analysed 12 weeks post-commencement of intervention.
Secondary outcome [4] 425535 0
Knee Injury and Osteoarthritis Outcome Score (KOOS-PF)
Timepoint [4] 425535 0
It will be analysed 12 weeks post-commencement of intervention.
Secondary outcome [5] 425537 0
Perceived recovery will be assess with a 6-point Likert Global rating of change (GROC) scale
Timepoint [5] 425537 0
It will be analysed 12 weeks post-commencement of intervention.

Eligibility
Key inclusion criteria
Insidious onset of anterior knee pain
• Anterior knee pain for at least 3 months
• Worst pain level in the previous week of at least 3 in a 0 to 10 numerical pain scale
• Presence of anterior knee pain when performing at least two of the following activities: sitting for a prolonged time, squatting, kneeling, running, walking up and down stairs, jumping, and landing.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of any lower limb surgery.
• Presence of any other knee injury in the last 6 months (e.g., patellar tendinopathy, meniscal or ligament injury, patellar luxation or sub-luxation).
• Metabolic or other disorders requiring medication (e.g., hypertension).
• Already strictly following an anti-inflammatory diet (e.g., low carbohydrate, high-fat, paleo, Mediterranean).
• Following a habitual diet that excludes animal products (e.g., Vegan diet).
• History of eating disorders or bariatric surgery.
• Dietary intervention by a qualified Dietitian in the last 3 months.
• Education or exercise therapy by a qualified Physiotherapist in the last 3 months.
• Knee injection in the last 3 months.
• Use of oral steroids and opiate treatment in the last month.
• Unable to understand written or spoken English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size was not formally determined for this feasibility study, as the primary aim is to inform a full-scale RCT regarding practicalities around recruitment procedures and the acceptability of the intervention. However, a sample size of 34 allows for the estimation of key feasibility parameters, such as a drop-out of 15%, with statistical significance set at 0.05 and 80% power.
Characteristics of the participants were reported descriptively. Feasibility outcomes were also reported descriptively, a full-scale trial was (i) recommended; (ii) recommended pending modifications or (iii) not recommended according to our a priori set of criteria. Within-group change in secondary continuous outcomes were reported as mean (95% confidence interval (CI)) change and evaluated with paired t-tests. Effect sizes were calculated to guide the interpretation of the power of the comparison. Effect size values were defined as small (0.2-0.5), medium (0.51-0.80), or large ( greater than or equal 0.81). Statistical analyses were performed using Statistical Package for the Social Sciences (IBM SPSS version 28.0) with an alpha set at 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
12/11/2024
Actual
Date of last data collection
Anticipated
29/01/2025
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314585 0
University
Name [1] 314585 0
La Trobe University
Country [1] 314585 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road and Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 316558 0
None
Name [1] 316558 0
Address [1] 316558 0
Country [1] 316558 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313620 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 313620 0
Ethics committee country [1] 313620 0
Australia
Date submitted for ethics approval [1] 313620 0
Approval date [1] 313620 0
19/06/2023
Ethics approval number [1] 313620 0
HEC23169

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

Contacts
Principal investigator
Name 128774 0
Dr Danilo de Oliveira Silva
Address 128774 0
La Trobe University Plenty Road and Kingsbury Dr, Bundoora VIC 3086Building HS3 (Room 513)
Country 128774 0
Australia
Phone 128774 0
+61 426 188 766
Fax 128774 0
Email 128774 0
[email protected]
Contact person for public queries
Name 128775 0
Danilo de Oliveira Silva
Address 128775 0
La Trobe University Plenty Road and Kingsbury Dr, Bundoora VIC 3086Building HS3 (Room 513)
Country 128775 0
Australia
Phone 128775 0
+61426188766
Fax 128775 0
Email 128775 0
[email protected]
Contact person for scientific queries
Name 128776 0
Danilo de Oliveira Silva
Address 128776 0
La Trobe University Plenty Road and Kingsbury Dr, Bundoora VIC 3086Building HS3 (Room 513)
Country 128776 0
Australia
Phone 128776 0
+61426188766
Fax 128776 0
Email 128776 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?
All the individual participant data reported in peer-reviewed publications (de-identified).
When will data be available (start and end dates)?
The data will be available immediately after the findings are published. The end date will be 15 years from the study's publication date.
Available to whom?
Data will be available for academics and stakeholders.
Available for what types of analyses?
Academic or stakeholders who request the data for pooling in systematic reviews and meta-analysis or data registries.
How or where can data be obtained?
Requests of IPD should be directed to the Principal Investigator via email.
[email protected]


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.