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Trial registered on ANZCTR


Registration number
ACTRN12621000970842
Ethics application status
Approved
Date submitted
16/06/2021
Date registered
26/07/2021
Date last updated
26/07/2021
Date data sharing statement initially provided
26/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of exercise in Systemic Lupus Erythematosus.
Scientific title
Investigating the effect of exercise on perceived fatigue and quality of life in adults with Systemic Lupus Erythematosus.
Secondary ID [1] 304286 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 322016 0
Condition category
Condition code
Inflammatory and Immune System 319736 319736 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two treatment groups being compared in this trial is an aerobic exercise program to a strength exercise program. Both exercise programs will be individually prescribed and tailored to the participants' rating of perceived exertion, by the principal investigator who is an Accredited Exercise Physiologist.

Both exercise programs will be performed at the Australian Catholic University, North Sydney gymnasium and supervised by a team of Exercise Scientists and Exercise Physiologists who have been trained by the principle investigator in the delivery of the exercise programs. Both exercise programs will be dose matched, with all participants performing their allocated exercise program in the gymnasium two times per week, 50-minutes in durations, and at moderate intensity [3 to 4 out of 10 based on your rating of perceived exertion (RPE), which is referred to as “somewhat hard”].

All exercise sessions will include a 10-minute warm-up (5-minutes walking on a treadmill and 5-minutes of body weight exercises replicable to the session), 32 minutes of their allocated type of exercise at moderate intensity exercise, and an 8-minute cool down which will include whole body stretches and breathing.

The aerobic exercise program will involve walking on a treadmill for 32 minutes, performing 4-minute moderate intensity intervals subsequent to 4-minute low intensity intervals [2 to 3 out of 10 based on your RPE, which is referred to as “light”]. Heart rate (HR) and RPE will be monitored throughout the 32-minute duration to ensure the participant is working within the desired RPE and HR intensities, and if they are reporting an RPE that is either too low or too high, adjustments may be made to the speed or incline of the treadmill.

The strength exercise program will involve a circuit of 8 whole body exercises performed at a dosage of 10 repetitions and 3 sets of each exercise. These exercises will be using mostly body weight for resistance, as well as the use of props such as TheraBand's, dumbbells, and kettle bells. RPE will be closely monitored during the 32-minute duration to ensure that the participant is working at the desired intensity, and if they are reporting an RPE that is either too low or too high, adjustments may be made to the exercises (for example, less or more resistance to the exercise).

Each participants' exercise program, regardless of exercise type, will be individualised based on their RPE. For example, for the aerobic exercise program, one participant may be walking on the treadmill at a speed of 5km/hour, where another participant may be walking on the treadmill at a speed of 4km/hour. For example, for the resistance exercise program, one participant may be performing a sit-to-stand exercise using their own body weight, and another participant might require an additional dumbbell for added resistance.
Intervention code [1] 320625 0
Treatment: Other
Intervention code [2] 320626 0
Rehabilitation
Comparator / control treatment
This trial will include an 'active control group', with the comparator being strength exercise. An aerobic exercise group will perform aerobic exercise two times per week, at moderate intensity, and individually prescribed and supervised by an exercise physiologist. The comparator will be a strength exercise group with the dosage and supervision matched. Both exercise programs will be held at the Australian Catholic University, North Sydney gymnasium.
Control group
Active

Outcomes
Primary outcome [1] 327604 0
Fatigue, assessed by the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-fatigue) questionnaire.
Timepoint [1] 327604 0
This will be measured before and after the 8-week intervention.
Primary outcome [2] 328172 0
Quality of life, assessed by the 36-Item Short Form Survey (SF-36), RAND version questionnaire.
Timepoint [2] 328172 0
This will be measured before and after the 8-week intervention.
Primary outcome [3] 328173 0
Disease activity, assessed by the the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) questionniare.
Timepoint [3] 328173 0
This will be measured before and after the 8-week intervention.
Secondary outcome [1] 395909 0
Aerobic capacity, assessed by a sub-maximal treadmill walking test.
Timepoint [1] 395909 0
This will be measured before and after the 8-week intervention.
Secondary outcome [2] 397928 0
Muscular strength and endurance, assessed by the Five Times Sit to Stand Test and 30-second Sit-to-stand test.
Timepoint [2] 397928 0
This will be measured before and after the 8-week intervention.
Secondary outcome [3] 397930 0
Upper body handgrip strength test assessed using a handheld dynamometer.
Timepoint [3] 397930 0
This will be measured before and following the 8-week intervention.
Secondary outcome [4] 397931 0
Post exertional fatigue assessed by the Fatigue and Energy Scale using an 11-point Likert scale with minimal descriptors, and bodily pain assessed using an 11-point Likert scale with minimal descriptors. This questionnaire will be performed using the University of Southern Queensland online survey tool at the end of the week i.e. Sunday.
Timepoint [4] 397931 0
This will be measured weekly during the 8-week intervention.
Secondary outcome [5] 397934 0
Inflammatory markers, including: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), complement components C3 and C4 and anti-double stranded DNA (anti-dsDNA) will be observed in the blood reports obtained by the participants' regular treating practitioner.
Timepoint [5] 397934 0
This will be obtained as close to the commencement and completion of the 8-week intervention, depending on when and if the participant had completed their usual blood test.
Secondary outcome [6] 398707 0
Individual experience assessed by a semi-structured one-on-one interview with a member of the research team
Timepoint [6] 398707 0
This will be measured after the intervention.

Eligibility
Key inclusion criteria
Adults (18+)

Diagnosis of systemic lupus erythematosus by the classification criteria ACR and the 2019 EULAR Classification Criteria for systemic lupus erythematosus.

Complete a self-created screening questionnaire by the principle investigator, as well as the Exercise & Sports Science Australia (ESSA) adult-pre-screening tool and be stratified as low-moderate risk. If they are deemed to be moderate-high risk, more information may need to be sought from their regular treating physician to determine their eligibility for inclusion. The principal investigator, Stephanie Frade, who is an Accredited Exercise Physiologist will be completing the screening with all participants over the phone, and will deem whether they are eligible and safe to complete the exercise program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Currently pregnant. This will be informed by a self-created screening tool that will be completed by the principle investigator over the phone prior to commencing their baseline assessment.
• Absolute contraindications including: Active lupus nephritis, myocarditis, or pericarditis. This will be informed by a self-created screening tool that will be completed by the principle investigator over the phone prior to commencing their baseline assessment.
• Relative contraindications. This will be informed by a self-created screening tool and Exercise & Sports Science Australia screening tool that will be completed by the principle investigator over the phone prior to commencing their baseline assessment.

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)
Allocation concealment will be performed by an independent third party who is not involved in the research project. This will be concealed through a central randomization process using a word document that has the participant code and allocated group, and emailed t to the research assistant delivering the program. Email correspondence will be completed through their institutional email accounts.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization will be performed using a random number generator online. If the number is 1, the participant will be allocated to the "strength exercise group", and if the number is 2, the participant will be allocated to the "aerobic exercise group". This will be performed by the same independent third party who is performing allocation concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This will be pre-post analysis of each of the key outcomes, with some measures (such as fibromyalgia, for example) used as a co-variate. It will be either an ANOVA or ANCOVA if the co-variates are of importance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19607 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 34243 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 308661 0
Other Collaborative groups
Name [1] 308661 0
Healthy Work Options
Country [1] 308661 0
Australia
Primary sponsor type
University
Name
University of Southern Queensland
Address
487-535 West Street
Toowoomba Qld 4350
Australia
Country
Australia
Secondary sponsor category [1] 309540 0
University
Name [1] 309540 0
Australian Catholic University
Address [1] 309540 0
25A Barker Rd, Strathfield NSW 2135
Country [1] 309540 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308589 0
University of Southern Queensland ethics committee
Ethics committee address [1] 308589 0
Ethics committee country [1] 308589 0
Australia
Date submitted for ethics approval [1] 308589 0
Approval date [1] 308589 0
06/05/2021
Ethics approval number [1] 308589 0
H21REA052

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

Contacts
Principal investigator
Name 111242 0
Mrs Stephanie Frade
Address 111242 0
University of Southern Queensland
487-535 West Street
Toowoomba, Queensland, 4350
Australia
Country 111242 0
Australia
Phone 111242 0
+61 412567110
Fax 111242 0
Email 111242 0
[email protected]
Contact person for public queries
Name 111243 0
Stephanie Frade
Address 111243 0
University of Southern Queensland
487-535 West Street
Toowoomba, Queensland, 4350
Australia
Country 111243 0
Australia
Phone 111243 0
+61 412567110
Fax 111243 0
Email 111243 0
[email protected]
Contact person for scientific queries
Name 111244 0
Stephanie Frade
Address 111244 0
University of Southern Queensland
487-535 West Street
Toowoomba, Queensland, 4350
Australia
Country 111244 0
Australia
Phone 111244 0
+61 412567110
Fax 111244 0
Email 111244 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.