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Trial registered on ANZCTR


Registration number
ACTRN12624000802505p
Ethics application status
Submitted, not yet approved
Date submitted
17/06/2024
Date registered
28/06/2024
Date last updated
28/06/2024
Date data sharing statement initially provided
28/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Supervised exercise for people with myositis
Scientific title
Effect of an exercise intervention on aerobic capacity in people with myositis: a waitlist randomised control trial
Secondary ID [1] 312303 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EXEMPLAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
idiopathic inflammatory myopathies 334044 0
Condition category
Condition code
Inflammatory and Immune System 330715 330715 0 0
Autoimmune diseases
Inflammatory and Immune System 330716 330716 0 0
Connective tissue diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised wait-list control study. Participants will be randomised by an independent researcher in a 1:1 ratio to participate in a structured, individualised, supervised exercise program (intervention group) in conjunction with their usual care or to usual care alone (wait-list control group). Usual care for people with myositis may include continuation of their pharmacological treatment, attendance to their usual medical appointments, and continuation of their usual day-to-day activities (for example, their usual exercise routine or hobbies).

Participants allocated to the intervention group will complete a 12 week (3 sessions per week, 45 to 60 minute session) structured, individualised, supervised exercise program. These sessions which will be undertaken in the Royal Prince Alfred Hospital Clinic at the Charles Perkins Centre face-to-face at least once per week, with at least one session per week administered via telehealth (supervised “live” on Microsoft Teams), and the remaining one session per week administered face-to-face or via telehealth based on participant preferences. The exercise program will be prescribed by an experienced Accredited Exercise Physiologist (minimum of 10 years of experience), and all exercise sessions will be supervised 1 on 1 by an appropriately trained exercise professional (accredited exercise physiologist and/or accredited exercise scientist)

The exercise program will include a combination of aerobic and resistance exercises and will be individually progressed from moderate to vigorous intensity over the 12 weeks, according to rating of perceived exertion (6 to 20 BORG scale for aerobic exercise; 0 to 10 BORG scale for strength exercise, "higher numbers = higher intensity") and heart rate response (using polar heart rate straps). The face-to-face exercise program will commence with a 5 minute dynamic warm up (body weight mobility and strength, replicating the strength based exercises) and a 5 minute light intensity cycle on a reclined cycle ergometer. The aerobic exercise component will include a 10 x 1 high intensity interval training (HIIT) protocol, which involves 1 min at "high intensity" and 1 min at "low intensity", for 4 to 10 rounds (progressing to 10 rounds over the 12 weeks). The resistance exercise component will include 6 to 8 compound strength exercises, with a load range of 8 to 10 repetition and 2 to 3 sets, and using a combination of Keiser machine weights and free weights. Examples of exercises include seated chest press, seated latissimus pull down, seated leg press, standing bicep curls, sit-to-stands or squats, and/or seated low pull. The telehealth exercise sessions will include a 10 minute dynamic warm up (body weight mobility and strength, replicating the aerobic and strength based exercises), followed by a circuit of 6 to 8 compound aerobic and strength exercises using either time (up to 1 minute) and/or load ranges of 8 to 10 reps and 2 to 3 sets. Examples of exercises include standing bicep curls, standing marches, bent over rows, sit-to-stands, and/or aerobic type movements such as step together and high knees. Adherence to the exercise sessions will be done by marking attendance to the exercise sessions and whether the session was telehealth or face-to-face.

The exercise program will also include education about the benefits of exercise, how to exercise safely, and ways to incorporate exercise in day-to-day life. The education will involve open-ended discussions done throughout the exercise intervention (i.e. before/during/after the exercise sessions). We will also provide participants with videos and/or fact sheets with exercise guidelines and takeaway home exercises.
Intervention code [1] 328844 0
Rehabilitation
Intervention code [2] 328880 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control group will continue with their usual care over the 12 week period. Usual care may include continuation of their prescribed pharmacologic treatment, attendance to medical appointments, and usual physical activity regime. Control participants will complete a suite of assessments at baseline (week 0), immediately post-intervention (week 12), and at follow up (36 weeks). Those assigned to the control group will be invited to receive the full 12 weeks exercise intervention on completion of the 36 week follow up assessment period.
Control group
Active

Outcomes
Primary outcome [1] 338562 0
Aerobic capacity measured as peak oxygen consumption (peak VO2).
Timepoint [1] 338562 0
Baseline (week 0), immediately post-intervention (week 12), and at follow up (36 weeks). However, the primary timepoint is week 12.
Secondary outcome [1] 436442 0
Upper body muscle strength (chest press)
Timepoint [1] 436442 0
Baseline (week 0), mid-way (6 weeks), immediately post-intervention (week 12), and at follow up (36 weeks).
Secondary outcome [2] 436443 0
Upper body muscle endurance (chest press)
Timepoint [2] 436443 0
Baseline (week 0), mid-way (6 weeks), immediately post-intervention (week 12), and at follow up (36 weeks).
Secondary outcome [3] 436444 0
Sustained aerobic capacity, as measured as peak Vo2
Timepoint [3] 436444 0
Baseline (week 0), immediately post-intervention (week 12), and at follow up (36 weeks).
Secondary outcome [4] 436628 0
Lower body muscle strength (leg press)
Timepoint [4] 436628 0
Baseline (week 0), mid-way (6 weeks), immediately post-intervention (week 12), and at follow up (36 weeks).
Secondary outcome [5] 436629 0
Lower body muscle endurance (leg press)
Timepoint [5] 436629 0
Baseline (week 0), mid-way (6 weeks), immediately post-intervention (week 12), and at follow up (36 weeks).

Eligibility
Key inclusion criteria
Greater than or equal to 18 years of age

Diagnosis of dermatomyositis, polymyositis or immune-mediated necrotizing myopathy (IMNM), made by a medical practitioner, and in accordance with European league against rheumatism (EULAR)/American college of rheumatology (ACR) Classification Criteria for Adult and Juvenile Idiopathic inflammatory myopathy (IIM) and their Major Subgroups (High probability more than 55% on calculator for IIM).

Disease duration greater than 3months

History of significant muscle inflammation (myositis) that has impacted health and been a major consideration in treatment decisions as judged by the treating physician

Willingness to provide informed consent and willingness to participate and comply with the study requirements

Deemed safe to exercise according to the Exercise and Sport Science Australia (ESSA) pre-screening form and baseline clinical assessments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 18 years of age

Inclusion Body Myositis (IBM)

Amyopathic Dermatomyositis (ADM)

Contraindication or inability to exercise as determined by the ESSA pre-screening form and baseline clinical assessments

Currently pregnant or planning pregnancy

Diagnosis of condition(s) that may limit ability and safety to perform exercise (e.g., unstable cardiovascular disease, uncontrolled congestive heart failure, known heart failure)

Active malignancy

Severe interstitial lung disease (ILD) with a diffusing capacity of the lungs for carbon monoxide (DLCO) <40% and/or a forced vital capacity (FVC) less than 60%

Renal impairment (estimated glomerular filtration rate (GFR) less than 30mL/min/1.73m2)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using an opaque sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomised blocks will be generated using statistical software with treatment allocations kept concealed from the investigator until after the participant has been enrolled (informed consent + inclusion/exclusion criteria assessed). Participants will be stratified according to disease duration (those with myositis duration more than 3 months to less than 18 months, and those with myositis duration greater than 18 months).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Wait-list controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
1/02/2025
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26691 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 42732 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 316695 0
Government body
Name [1] 316695 0
National Health and Medical Research Council Investigator Grant.
Country [1] 316695 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318961 0
None
Name [1] 318961 0
Address [1] 318961 0
Country [1] 318961 0
Other collaborator category [1] 283091 0
Hospital
Name [1] 283091 0
Royal Prince Alfred Hospital
Address [1] 283091 0
Country [1] 283091 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315474 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 315474 0
https://www.slhd.nsw.gov.au/rpa/research/
Ethics committee country [1] 315474 0
Australia
Date submitted for ethics approval [1] 315474 0
01/06/2024
Approval date [1] 315474 0
Ethics approval number [1] 315474 0

Summary
Brief summary
This is a randomised wait-list control study. Participants will be randomised to participate in either a structured, individualised, supervised exercise program (intervention group) or to usual care (wait-list control group). Participants allocated to the intervention group will complete a 12 week, 3 times per week, structured, individualised, 1 on 1 supervised exercise program (mixed between face to face and "live" telehealth on Microsoft teams). Participants allocated to the control group will continue with their usual care over the 12 week period and then be invited to receive the full 12 weeks intervention on completion of the 36 weeks follow up assessment period. Blinded assessments will be undertaken at baseline (week 0), following the intervention (Week 12), and at follow-up (36 weeks).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134806 0
Prof Mandana Nikpour
Address 134806 0
The University of Sydney, Camperdown, New South Wales, 2006
Country 134806 0
Australia
Phone 134806 0
+61 2 9515 9251
Fax 134806 0
Email 134806 0
[email protected]
Contact person for public queries
Name 134807 0
Dr Stephanie Frade
Address 134807 0
The University of Sydney, Camperdown, New South Wales, 2006
Country 134807 0
Australia
Phone 134807 0
+61 2 9515 9251
Fax 134807 0
Email 134807 0
[email protected]
Contact person for scientific queries
Name 134808 0
Dr Stephanie Frade
Address 134808 0
The University of Sydney, Camperdown, New South Wales, 2006
Country 134808 0
Australia
Phone 134808 0
+61 2 9515 9251
Fax 134808 0
Email 134808 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
Despite efforts to anonymize data, there remains a risk of re-identification, which could compromise participants' personal information. Moreover, data can be misinterpreted if used without proper context or understanding, leading to incorrect conclusions.


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.