Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000156583
Ethics application status
Approved
Date submitted
16/01/2024
Date registered
19/02/2024
Date last updated
15/09/2024
Date data sharing statement initially provided
19/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding Knee Health and Knee Sounds in People with Knee Crepitus
Scientific title
The exercise physiology knee clinic study - linking knee sounds and knee health
Secondary ID [1] 311338 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 332593 0
Condition category
Condition code
Musculoskeletal 329287 329287 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All study participants will receive client-specific education of exercise and osteoarthritis (OA) by an Accredited Exercise physiologist (AEP)/AEP student (personalised knee health information) in a short verbal exchange (10min) following baseline data collection (conducted by an AEP/AEP student). Advice will focus on engaging in 1) aerobic and resistance exercise, 2) flexibility training and 3) education about OA/crepitus, its prognosis, causes and 4) role of exercise as is standard practice for AEPs (Hinman et al., 2023). This will not be recorded.

the following outcomes will be assessed during the 1hr study visit to the University of Sydney campus Camperdown:
Knee sounds: recorded by handheld sound recording device during lower limb physical health and function outcomes (e.g. squatting).
Anthropometry and demographics: height, weight, BMI, waist circumference, age, gender, race, comorbid conditions, history of knee injury/surgery, occupation, resting blood pressure.
Questionnaires: Exercise and Sports Science pre-screening tool, Knee Injury and Osteoarthritis Outcome Score, International Physical activity questionnaire (IPAQ), Tampa Scale of Kinesiophobia, Pain self-efficacy questionnaire, Pain catastrophising scale, Patient global impression of change scale.
Qualitative: participant perceptions/interpretation of crepitus, function, pain and related exercise behaviours (short semi-structured interview).
Physical health and functional capacity: 3-repetition maximal (3-RM) strength test of knee extension, knee flexion, and leg press, timed up and go (TUG) test.
Immune cells and biomarkers: blood sampling of venous blood (10mL total) -optional (and may occur on a different day/time).
3 months after initial study visit: participant perceptions/interpretation of change in crepitus, function, pain and related exercise behaviours and perceptions of the initial AEP clinic visit (short semi-structured interview).
Intervention code [1] 327781 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337109 0
Knee Health (pain and function)
Timepoint [1] 337109 0
Baseline and 3 months post-intervention delivery.
Secondary outcome [1] 431268 0
perceptions of the initial AEP clinic visit
Timepoint [1] 431268 0
Baseline and 3 months post-intervention delivery.
Secondary outcome [2] 431738 0
Perceptions of pain.
Timepoint [2] 431738 0
Baseline and 3 months post-intervention delivery.
Secondary outcome [3] 431793 0
confidence of people with ongoing pain have in performing activities of daily living
Timepoint [3] 431793 0
Baseline and 3 months post-intervention delivery.
Secondary outcome [4] 431794 0
Evaluation of individual's pain experience
Timepoint [4] 431794 0
Baseline and 3 months post-intervention delivery.
Secondary outcome [5] 431795 0
Perceptions of the efficacy of the intervention
Timepoint [5] 431795 0
3 months post-intervention delivery

Eligibility
Key inclusion criteria
• Greater than 18 years of age.
• Any of knee crepitus, knee osteoarthritis or concerns regarding knee health.
• Willingness to provide informed consent and comply with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Total knee replacement.
• Recent surgery (<6 months).
• Uncontrolled psychiatric illness.
• Recent onset cardiovascular disease (coronary artery disease, myocardial infarction, etc, <6 months).
• Musculoskeletal pathology that would impede capacity to carry out the exercise assessments and intervention.
• Participants who are not fluent in English or who have difficulty understanding English.
• Other form of arthritis.
• Pregnancy.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/03/2024
Actual
4/03/2024
Date of last participant enrolment
Anticipated
7/10/2024
Actual
Date of last data collection
Anticipated
6/01/2025
Actual
Sample size
Target
200
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315358 0
University
Name [1] 315358 0
University of Sydney
Country [1] 315358 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW
Country
Australia
Secondary sponsor category [1] 317687 0
None
Name [1] 317687 0
Address [1] 317687 0
Country [1] 317687 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314277 0
University of Sydney Human Research and Ethics Committee
Ethics committee address [1] 314277 0
Ethics committee country [1] 314277 0
Australia
Date submitted for ethics approval [1] 314277 0
26/01/2024
Approval date [1] 314277 0
19/02/2024
Ethics approval number [1] 314277 0
2024/026

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

Contacts
Principal investigator
Name 131030 0
Prof Jeanette Thom
Address 131030 0
Susan Wakil Health Building, Western Ave, University of Sydney, Camperdown NSW 2050
Country 131030 0
Australia
Phone 131030 0
+61 2 8627 6773
Fax 131030 0
Email 131030 0
[email protected]
Contact person for public queries
Name 131031 0
Callum Baker
Address 131031 0
Susan Wakil Health Building, Western Ave, University of Sydney, Camperdown NSW 2050
Country 131031 0
Australia
Phone 131031 0
+61 2 8627 6773
Fax 131031 0
Email 131031 0
[email protected]
Contact person for scientific queries
Name 131032 0
Callum Baker
Address 131032 0
Susan Wakil Health Building, Western Ave, University of Sydney, Camperdown NSW 2050
Country 131032 0
Australia
Phone 131032 0
+61 2 8627 6773
Fax 131032 0
Email 131032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Group data will be reported


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.