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Trial registered on ANZCTR


Registration number
ACTRN12622001231730
Ethics application status
Approved
Date submitted
14/03/2022
Date registered
12/09/2022
Date last updated
20/09/2022
Date data sharing statement initially provided
12/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
How should exercise and education be delivered in exercise physiology interventions in people with knee osteoarthritis?
Scientific title
Feasibility of 'exercising into pain' in patients with symptomatic knee osteoarthritis.
Secondary ID [1] 306511 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 325380 0
Condition category
Condition code
Musculoskeletal 322763 322763 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive the ‘painful’ exercise program, which will be delivered in a one-on one setting by an accredited exercise physiologist. The intervention group will consist of 2x1-hour sessions per week for 6 weeks and include a combination of both aerobic (e.g. stationary cycling/treadmill walking) and upper- and lower-body resistance exercise (e.g. leg press, seated row) as recommended by knee osteoarthritis guidelines. Painful exercise will only be prescribed for the impacted lower extremity muscles (e.g. quadriceps, hamstring, calves and glutes) due to the knee osteoarthritis pain. The painful exercises will be prescribed to evoke a transient increase in knee OA pain at rest, with pain returning to baseline following the exercise session, or within a few hours following exercise (at most 24 hours post-exercise). Participants will be advised to ‘exercise into pain’ which will be monitored through participant self-reports using cues routinely used in clinical practice i.e. exercise whereby pain is ‘manageable/ tolerable’. Pain will also be assessed using a VAS pre and post exercise. Exercise load will be individualised to each participant to ensure the exercise intensity causes the required level of pain. In addition to pain, exercise intensity will also be monitored during each exercise session using the 0-10 rating of perceived exertion scale (RPE). Progression of exercise will entail: Resistance exercises progressed according to the principles of progressive overload (e.g. increase in load when a pre-determined amount of reps have been achieved) and neuromuscular exercises progressed according to principles of graded exercise (e.g. increasing exercise difficulty when a pre-determined number of reps can be completed). Aerobic exercise will be progressed via an increase in volume (e.g. time) and then intensity (e.g. walking speed). Participants will diarise their medication usage during the intervention period. The intervention groups will also receive education designed specifically for this study by the research team, addressing key concepts including benefits of exercise for knee OA and self-management principles (e.g. goal setting, activity pacing, graded activity, medication usage). Education is standardised for both groups and will be delivered throughout the sessions via audio-visual material using oral explanations, summaries, images, metaphors, diagrams and written educational material.
Intervention code [1] 323118 0
Rehabilitation
Comparator / control treatment
The control group will also receive the same combination of aerobic and resistance exercise as the intervention group. However, participants in this group will be advised to exercise at an intensity that does not aggravate their knee-related osteoarthritis pain. Efforts will be made to individualise load for participants to ensure they are training at the correct intensity (e.g. pain-free). In addition to pain, exercise intensity will also be monitored during each exercise session using the 0-10 rating of perceived exertion scale (RPE). Progression of exercise will be per the following: Resistance exercises progressed according to the principles of progressive overload (e.g. increase in load when a pre-determined amount of reps have been achieved) and neuromuscular exercises progressed according to principles of graded exercise (e.g. increasing exercise difficulty when a pre-determined number of reps can be completed). Aerobic exercise loads will be dependent on responses from the control group (e.g pain-free), with progression to be achieved via an increase in volume (e.g. time) and then intensity (e.g. walking speed). The control group will also receive education, addressing key concepts including benefits of exercise for knee OA and self-management principles (e.g. goal setting, activity pacing, graded activity, medication usage). Education is standardised for both groups and will be delivered throughout the sessions via audio-visual material using oral explanations, summaries, images, metaphors, diagrams and written educational material.

Control group
Dose comparison

Outcomes
Primary outcome [1] 330742 0
Our primary outcome is the feasibility of the intervention. This will be measured by a composite of: determining participant recruitment (number who consented/number eligible, x 100%), retention (number who completed the end-intervention (week 8) assessment/number who completed baseline assessment x 100%), adherence (number of completed exercise sessions/number of scheduled exercise sessions, x 100%) and compliance (i.e. number of exercises completed within a session at the prescribed intensity or level of pain/number of exercises pre-determined by the exercise physiologist x 100%). All data for each component will be determined via an audit of study screening and enrolment logs.
Timepoint [1] 330742 0
Immediately following the post-assessment session (Week 8).
Secondary outcome [1] 409330 0
Clinical pain will be measured using a 0-10 numeric pain rating scale.
Timepoint [1] 409330 0
Clinical pain will be assessed during initial assessment (Week 1), throughout the intervention (Weeks 2-7), the post-assessment session (Week 8) and at the 3 month follow up (Week 20).
Secondary outcome [2] 409369 0
Experimental pain will be measured via pressure pain threshold testing. This will be assessed using a handheld algometer over the muscle bellies of the arm (biceps brachii), hand (first dorsal interosseous), thigh (rectus femoris) and shin (tibialis anterior).
Timepoint [2] 409369 0
Experimental pain will be assessed during the initial assessment (Week 1) and the post-assessment session (Week 8).
Secondary outcome [3] 409370 0
Self-reported physical function will be measured via the Knee injury and Osteoarthritis Outcome Score.
Timepoint [3] 409370 0
During initial assessment (Week 1), the post-assessment session (Week 8), and at 3 month follow up (Week 20)
Secondary outcome [4] 409371 0
Aerobic function will measured via a 6 minute walk test. During the 6MWT, participants will be asked to walk a set length as quickly and as safely as possible for 6 min. Heart rate and RPE are monitored every minute.
Timepoint [4] 409371 0
During initial assessment (Week 1) and in the post-assessment session (Week 8).
Secondary outcome [5] 409372 0
Performance and strength will be assessed via a 30 secs chair stand test (maximum number of chair stands performed in 30 seconds), timed up and go test (time taken to walk 3m then return and sit down) and a one repetition maximum test on the leg press (maximum weight pressed for one repetition).
Timepoint [5] 409372 0
During initial assessment (Week 1) and in the post-assessment session (Week 8).
Secondary outcome [6] 409373 0
Self-reported fear of movement will be measured via the Tampa Scale of Kinesiophobia
Timepoint [6] 409373 0
During initial assessment (Week 1), the post-assessment session (Week 8), and at 3 month follow up (Week 20).
Secondary outcome [7] 409374 0
Self-reported confidence in performing activities when in pain will be measured via the Pain Self-Efficacy Questionnaire.
Timepoint [7] 409374 0
During initial assessment (Week 1), the post-assessment session (Week 8), and at 3 month follow up (Week 20).
Secondary outcome [8] 409375 0
Self-reported pain catastrophising will be measured via the Pain Catastrophising Questionnaire.
Timepoint [8] 409375 0
During initial assessment (Week 1), the post-assessment session (Week 8), and at 3 month follow up (Week 20).
Secondary outcome [9] 409376 0
Self-reported physical activity levels will be measured via the short-form of the International Physical Activity Questionnaire
Timepoint [9] 409376 0
During initial assessment (Week 1), the post-assessment session (Week 8), and at 3 month follow up (Week 20).
Secondary outcome [10] 409377 0
Participant attitude and beliefs about the intervention which will be measured using semi-structured interviews. The interview questions have been developed to understand participants’ beliefs on the intervention.
Timepoint [10] 409377 0
Immediately following the post-assessment session (Week 8)
Secondary outcome [11] 409378 0
The patient's belief about the efficacy of treatment will be measured via the Patient global impression of change scale
Timepoint [11] 409378 0
During the post-assessment session (Week 8)

Eligibility
Key inclusion criteria
1. aged 18 years or older and are able to speak, read and write English
2. have a diagnosis of symptomatic/painful osteoarthritis in one or both knees and no other leg injuries/disabilities or recent surgeries
3. is medically suitable to perform moderate-intensity exercise
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. the primary cause of pain is something other than knee osteoarthritis
2. have been diagnosed with a serious psychiatric illness (e.g. major depression or severe anxiety)
3. have been diagnosed with a serious cardiovascular, cardiopulmonary or neurological disease that precludes participation in moderate-intensity exercise

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)
Screening to determine eligibility for the study will be performed without knowledge of the allocation for an enrolled participant. Allocation concealment will be done using sealed opaque envelopes. These will be created and provided to the research team by someone external to the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will occur using a random number generated table in Microsoft Excel. This will be done by someone external to the research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants will be aware that they are receiving exercise and education for knee osteoarthritis. However, they will be blinded to the different types of exercise being provided in the Intervention and Control arms as well as the overall study hypotheses. Pressure pain threshold will be assessed by an investigator who is blind to the education received by participants. Data analysis will be blinded.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size:
The total sample size for the project is 20 (n=10 in the painful exercise group and n=10 in the non-painful exercise group). For a feasibility study, it is inappropriate to calculate sample size based on desired statistical power to detect a treatment effect because the primary aim of the study is to assess if a full trial can or should be conducted using the procedures and protocol of the feasibility study. To achieve the primary objective related to feasibility outcomes, we estimate that 20 participants (10 per group) would be adequate to meet the research aims and answer the research questions related to assessment of the feasibility of recruitment, retention, adherence and compliance rates.

Analysis of outcomes:
Participant data will be analysed according to their assigned randomisation group using intention-to-treat. Feasibility will be determined based on the study’s recruitment, retention, adherence and compliance rates, which need to be >70% for >70% of participants for the intervention for that group to be deemed feasible. As this is a feasibility study, we will not conduct formal statistical testing for the effect of painful and non-painful exercise on self-reported outcomes (e.g. pain, function, kinesiophobia, self-efficacy, catastrophising, patient global impression of change) and functional tests (e.g. 6 minute walk test, chair stand test, timed up and go test and leg press one-repetition maximum test). Rather, we will perform descriptive analyses on these data (mean and standard deviation for pre- and post-intervention, mean difference and 95% confidence interval within- and between-group changed) and present these as exploratory. For data regarding participants’ attitudes and beliefs about the intervention, the recorded interviews will be independently transcribed verbatim and gathered for the subsequent analysis. The data will be analysed via thematic analysis. This approach recognises that data will be co-created by two researchers independently through an interactive process.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/09/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
30/05/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37061 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 310856 0
University
Name [1] 310856 0
The University of New South Wales
Country [1] 310856 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
The University of New South Wales, Sydney, NSW, 2052. Australia
Country
Australia
Secondary sponsor category [1] 312112 0
None
Name [1] 312112 0
Address [1] 312112 0
Country [1] 312112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310419 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 310419 0
Ethics committee country [1] 310419 0
Australia
Date submitted for ethics approval [1] 310419 0
28/02/2022
Approval date [1] 310419 0
08/04/2022
Ethics approval number [1] 310419 0

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

Contacts
Principal investigator
Name 117598 0
Dr Matthew Jones
Address 117598 0
School of Health Sciences
The University of New South Wales
Sydney, NSW 2052
Country 117598 0
Australia
Phone 117598 0
+61 2 9348 0032
Fax 117598 0
Email 117598 0
[email protected]
Contact person for public queries
Name 117599 0
Adrian Ram
Address 117599 0
School of Health Sciences
The University of New South Wales
Sydney, NSW 2052
Country 117599 0
Australia
Phone 117599 0
+61 2 9348 0032
Fax 117599 0
Email 117599 0
[email protected]
Contact person for scientific queries
Name 117600 0
Adrian Ram
Address 117600 0
School of Health Sciences
The University of New South Wales
Sydney, NSW 2052
Country 117600 0
Australia
Phone 117600 0
+61 2 9348 0032
Fax 117600 0
Email 117600 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?

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.