Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000569707
Ethics application status
Approved
Date submitted
25/03/2022
Date registered
13/04/2022
Date last updated
2/10/2023
Date data sharing statement initially provided
13/04/2022
Date results information initially provided
2/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Why does Good Living with Arthritis Denmark ( GLA:D®) work? A pilot study investigating the link between biomechanical factors and a successful outcome following a movement retraining program for knee osteoarthritis.
Scientific title
Why does Good Life with Arthritis: Denmark(GLA:D® )work? A pilot study investigating the link between biomechanical factors and a successful outcome following a movement retraining program for knee osteoarthritis.
Secondary ID [1] 306769 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 325784 0
Condition category
Condition code
Musculoskeletal 323122 323122 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 323123 323123 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will assess the biomechanical effects of a neuromuscular exercise program, GLA:D® (Good Life with Osteoarthritis in Denmark).
The GLA:D® program is a multicomponent intervention consisting of the core recommended non-surgical treatments of exercise and education for those who have been diagnosed with hip or knee osteoarthritis.
GLA:D® is delivered by certified GLA:D® physiotherapists and consists of 2 education sessions and 12 individual or group-based exercise sessions over a 6–8-week period.
The patient education sessions consist of 2 (60-90 minute) education sessions about osteoarthritis management delivered by a certified physiotherapist.

The aim is to have Education 1 completed prior to the first exercise session and Education 2 completed within the first 2 weeks of commencing the exercise sessions. The feasibility of this will be assessed as part of this study. All participants will be provided with a GLA:D Education booklet which summarises key aspects of both education sessions.

The exercise program is delivered over 12 (60 minute) sessions with a focus on a neuromuscular exercise program. Patients are encouraged to complete the program preferably in a small physiotherapy supervised group of approximately 4-6 people, however, may be completed as a home program or via telehealth.
The exercise component consists of :
• 10 minute warmup on exercise bike or other suitable method
• lower limb circuit program (10 exercises in total)
• Cool down
Exercises include:
• 2 abdominal/core exercises using a gym ball
• 2 dynamic alignment exercises using an exercise slider
• 4 lower limb strengthening exercises using TheraBand
• 2 functional exercises consisting of a sit to stand and a step up requiring a sturdy chair and a step.

Participants aim to perform 2-3 sets of 10-15 repetitions of each exercise. Each participant is monitored individually according to their pain intensity and progression of exercise difficulty occurs if good quality of the exercise can be maintained. Exercises are performed on both legs, with focus on the affected leg using mirror provided visual feedback (1).

Participants will be provided with the GLA:D specific exercise booklet which allows recording of each session completed, pain levels pre-post session and recording of the sets/repetitions and level of exercise difficulty completed.

A study specific form will be provided to each participant prior to commencing the study that allows for recording of all upcoming class and education appointments and study appointments related to their assessment in the biomechanics lab.

(1) Skou ST and Roos EM. Good Life with osteoArthritis in Denmark (GLA:D): evidence-based education and supervised neuromuscular exercise delivered by certified physiotherapists nationwide. BMC Musculoskelet Disorders, 2017. 18(1): p. 72.
Intervention code [1] 323221 0
Rehabilitation
Intervention code [2] 323222 0
Treatment: Other
Intervention code [3] 323223 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330889 0
Changes in knee joint loads (KAM, KAM impulse and KFM) following an 8 week education and exercise program (composite measure)
Procedure for measurement of joint reaction forces and joint moments will be conducted in the biomechanics lab at University of Canberra using VICON system, three AMTI force plate and 12 infrared VICON MX-40 cameras operating at 200HZ. 11. Data extraction and normalising will be performed using TempNormGUI, a custom written software script for MATLAB (MathWorks, USA). 3D joint moments will be calculated using inverse dynamics.
Timepoint [1] 330889 0
Baseline and 8 weeks post-intervention commencement
Secondary outcome [1] 408347 0
Changes in muscle co-contraction (VM/VL/BF/SM) following an 8 week education and exercise program ( composite measure)
Surface EMG will be collected for lateral knee muscles (biceps femoris and vastus lateralis) and medial knee muscles (vastus medialis and semimembranosus). Mean normalised muscle activation during the initial loading phase (stance phase) will be calculated for VM,VL,SM and BF and the ratio of lateral to medial cocontraction will be calculated.
Timepoint [1] 408347 0
Baseline and 8 weeks post intervention commencement
Secondary outcome [2] 408348 0
Changes in timing of muscle activation patterns following an 8 week education and exercise program (composite measure). Onset/offset duration will be calculated using surface EMG for lateral muscles (VL, BF) and medial muscles ( VM, SM).
Timepoint [2] 408348 0
Baseline and 8 weeks post intervention commencement
Secondary outcome [3] 408349 0
self-reported pain
Measured by NRS pain 0-100 ( pain last month and average pain)
Timepoint [3] 408349 0
Baseline, 8 and 12 weeks post intervention commencement
Secondary outcome [4] 408350 0
Functional performance 30 second sit to stand test
Timepoint [4] 408350 0
Baseline and 8 weeks post intervention commencement
Secondary outcome [5] 408351 0
Change in willingness to undertake surgery following an 8 week exercise and education program. Measured by asking participant the GLAD question ""Do you have so much trouble and pain from your [affected joint] that you want to have surgery?"
Timepoint [5] 408351 0
Baseline, 8 weeks and 12 weeks post intervention commencement
Secondary outcome [6] 408364 0
Knee joint flexion ROM measured with a goniometer
Timepoint [6] 408364 0
Baseline and 8 weeks post intervention commencement
Secondary outcome [7] 408529 0
Change in pain and function measured by KOOS12 ( composite measure)
Timepoint [7] 408529 0
Baseline, 8 weeks and 12 weeks post intervention commencement
Secondary outcome [8] 408530 0
Functional performance walking speed measured by 40 metre fast paced walk test
Timepoint [8] 408530 0
Baseline and 8 weeks post intervention commencement

Eligibility
Key inclusion criteria
1. Joint problems from the knee that have resulted in contact with the health care system
2. Clinical diagnosis of knee OA
3. Over age 45, movement-related knee pain, morning stiffness < 30 minutes and any
of the following crepitus, restricted movement or bony enlargements
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Primary joint problems due to other reasons, for example, tumour, inflammatory joint disease such as rheumatoid arthritis, and sequelae after hip fracture
2. Other symptoms that are more pronounced than the osteoarthritis problems, for example chronic, generalized pain or fibromyalgia
3. Does not understand English (questionnaire and education sessions for GLAD Australia)
4. The index knee (most symptomatic knee) has undergone total knee replacement surgery.
5. Inability to comply with the requirements of both the GLA:D program and the pilot study
Inability to attend 3-month follow up.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This will be an exploratory and feasibility study which aims to determine whether a future trial is warranted and will assess practical considerations such as patient flow and ease of recruitment. We propose to test our research methods (collection of biomechanical factors) for a future study.
This is a pilot study and not fully powered. A sample size of 30 is believed to be suitable in order to assess population variance and assist with sample size calculation for a future study (1). Descriptive statistics of preliminary biomechanical data will be assessed.

(1) Billingham SA, Whitehead AL, and Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol, 2013. 13: p. 104.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2022
Actual
16/05/2022
Date of last participant enrolment
Anticipated
31/12/2022
Actual
1/02/2023
Date of last data collection
Anticipated
1/04/2023
Actual
28/04/2023
Sample size
Target
30
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 37157 0
2617 - Belconnen
Recruitment postcode(s) [2] 37160 0
2617 - University Of Canberra
Recruitment postcode(s) [3] 37161 0
2617 - Bruce
Recruitment postcode(s) [4] 37162 0
2606 - Woden

Funding & Sponsors
Funding source category [1] 311109 0
University
Name [1] 311109 0
University of Canberra
Country [1] 311109 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari Street
Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 312441 0
None
Name [1] 312441 0
Address [1] 312441 0
Country [1] 312441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310639 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 310639 0
ACT Health
PO BOX 11
Woden ACT 2606

Ethics committee country [1] 310639 0
Australia
Date submitted for ethics approval [1] 310639 0
11/05/2021
Approval date [1] 310639 0
31/08/2021
Ethics approval number [1] 310639 0
ACT Reference: 2021.ETH.00061

Summary
Brief summary
The purpose of this study is to investigate the effect of a combined exercise and education intervention on biomechanics in those with knee osteoarthritis. We currently do not understand the reasons why people may improve with exercise interventions. This exploratory study will examine changes in muscle activation patterns and joint load following the GLA:D® program and see if this is related to improvements in pain or function or influences a person’s willingness to undertake surgery.

GLA:D® (Good Living Arthritis Denmark) is a program for hip and knee osteoarthritis consisting of 2 education sessions and 12 physiotherapy delivered group exercise classes delivered twice weekly over 6-8 weeks.

Biomechanical measurements such as knee joint loads (knee adduction moment and knee flexion moment) and muscle activation patterns (timings and co-contractions) will be measured at baseline and immediately following the GLA:D® program at 8 weeks. The relationship between biomechanical changes following the program and changes in pain and function or a person's willingness to undertake joint replacement surgery will be evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118358 0
Ms Jacqui Couldrick
Address 118358 0
University of Canberra
11 Kirinari Street
Bruce ACT 2617
Country 118358 0
Australia
Phone 118358 0
+61 418270358
Fax 118358 0
Email 118358 0
[email protected]
Contact person for public queries
Name 118359 0
Ms Jacqui Couldrick
Address 118359 0
University of Canberra
11 Kirinari Street
Bruce ACT 2617
Country 118359 0
Australia
Phone 118359 0
+61 418270358
Fax 118359 0
Email 118359 0
[email protected]
Contact person for scientific queries
Name 118360 0
Ms Jacqui Couldrick
Address 118360 0
University of Canberra
11 Kirinari Street
Bruce ACT 2617
Country 118360 0
Australia
Phone 118360 0
+61 418270358
Fax 118360 0
Email 118360 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15560Ethical approval    383825-(Uploaded-25-03-2022-12-02-14)-Study-related document.pdf
15561Informed consent form    383825-(Uploaded-25-03-2022-12-03-59)-Study-related document.pdf



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.