Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000063718
Ethics application status
Approved
Date submitted
10/12/2021
Date registered
20/01/2022
Date last updated
20/01/2022
Date data sharing statement initially provided
20/01/2022
Date results information initially provided
20/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and effectiveness of telehealth exercise in Systemic Lupus Erythematosus
Scientific title
Feasibility and effectiveness of telehealth exercise on fatigue, quality of life, and strength outcomes in Systemic Lupus Erythematosus
Secondary ID [1] 306013 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 324649 0
Condition category
Condition code
Musculoskeletal 322101 322101 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 322221 322221 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study was a single group pilot intervention of exercise. All participants underwent an 8-week, two days per week, 45-minute, one-on-one telehealth-supervised exercise program. Exercise was performed at moderate intensity, with a rating of perceived exertion (RPE) between 3-4 out of 10, in accordance with the American College of Sports Medicine (ACSM) intensity guidelines. All participants were allocated at least 48 h of relative rest (i.e.: no structured exercise) between the two sessions, however, participants were not advised to discontinue their regular exercise during this time. All telehealth exercise sessions were conducted in real-time using Zoom (video conferencing software) by two Accredited Exercise Physiologists AEPs (i.e., a research assistant (SG) delivered one session per week, and the principal investigator of the project (SF) delivered the second session of the week, throughout the duration of the program).

All participants received the same exercise program. The 45-minute moderate intensity exercise session comprised of a 10-minute seated mobility flow warm up which included ten chair-based mobility yoga exercises targeting all joints of the body, a 25–30-minute whole-body functional strength circuit, and 5-minutes of static stretches and breathing to cool down. The functional strength circuit was designed in accordance with the ACSM resistance training guidelines for muscular strength, with exercise volume comprising of 2-4 sets and 8-12 repetitions, and rest periods of 15-30 seconds between each exercise, 1 minute rest between each set, and inclusion of 6-8 exercises focusing on major muscle groups. The program was structured as a circuit, with 6-8 exercises comprising 1 set. All exercises were functional movements that are replicable to activity of daily living such as push, pull, squat, lunge, locomotion, and rotation, using either their own body weight, exercise apparatus such as resistance bands or external weights. Given that the exercise sessions were completed in the participants’ home with minimal equipment, a TheraBand and resistance loop band was sent to all participants involved in the study for consistency of equipment available and exercise programming.

RPE was used as the primary tool to substantiate an increase in volume or intensity over the 8-week period. For example, the exercises commenced with 2 sets and progressed to 3 sets, and exercise repetitions commenced at 8 reps and progressed to 12 reps. However, to maintain the desired moderate RPE intensity of 3-4/10 for all participants through-out the intervention, the intensity of an exercise slightly varied between participants.
Intervention code [1] 322418 0
Treatment: Other
Intervention code [2] 322518 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329857 0
Adherence to the 8-week intervention. This will be measured by recording the number of sessions that participants attended/missed.
Timepoint [1] 329857 0
8 weeks post-intervention commencement
Primary outcome [2] 329858 0
Telehealth usability and satisfaction of the 8-week intervention. This is a composite outcome derived from results from one questionnaire that includes questions about both the usability and satisfaction of the telehealth intervention. This will be measured using a previously validated questionnaire titled "telehealth usability and satisfaction questionnaire".
Timepoint [2] 329858 0
8 weeks post-intervention commencement
Primary outcome [3] 329859 0
Personal experience and satisfaction of the program. This will be measured by a self-created semi-structured one on one interview that was designed specifically for this study.
Timepoint [3] 329859 0
8 weeks post-intervention commencement
Secondary outcome [1] 404061 0
Fatigue. This will be measured by FACIT- F (functional assessment of chronic illness therapy)
Timepoint [1] 404061 0
Baseline & 8 weeks post-intervention commencement
Secondary outcome [2] 404062 0
Quality of life. This will be measured by SF36 (short form-36 item questionnaire)
Timepoint [2] 404062 0
Baseline & 8 weeks post-intervention commencement
Secondary outcome [3] 404070 0
Upper body muscular endurance. This will be measured using a 30-second arm curl test.
Timepoint [3] 404070 0
Baseline & 8 weeks post-intervention commencement
Secondary outcome [4] 404071 0
Lower body muscular endurance. This will be measured using a 30-second sit-to-stand test.
Timepoint [4] 404071 0
Baseline & 8 weeks post-intervention commencement
Secondary outcome [5] 404072 0
Lower body muscular strength. This will be measured using a five-time sit-to-stand test.
Timepoint [5] 404072 0
Baseline & 8 weeks post-intervention commencement
Secondary outcome [6] 404073 0
Aerobic capacity. This will be measured using a 2-minute step test.
Timepoint [6] 404073 0
Baseline & 8 weeks post-intervention commencement

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 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.
• Access to a computer/phone/tablet and internet connection.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Currently pregnant.
• Absolute contraindications including: Present and significant lupus nephritis, myocarditis, or pericarditis.
• Relative contraindications will be informed by the screening tool and correspondence from their regular treating physician.

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
Quantitative data were analysed using descriptive statistics. Quantitative data analysis will include within group comparisons using an ANCOVA model. For within group analyses, participants served as their own controls, and post-intervention measures were adjusted using baseline scores as covariates. Adverse events, withdrawals, and participants dropped out or lost to follow up was reported as counts. Effect sizes were calculated as Cohen’s d for univariate effects within groups, and as eta squared for omnibus effect sizes (variance accounted for by group membership).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/09/2021
Date of last participant enrolment
Anticipated
Actual
1/10/2021
Date of last data collection
Anticipated
Actual
5/12/2021
Sample size
Target
10
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21308 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 36189 0
2065 - Royal North Shore Hospital

Funding & Sponsors
Funding source category [1] 310355 0
Other
Name [1] 310355 0
Healthy work options
Country [1] 310355 0
Australia
Funding source category [2] 310356 0
University
Name [2] 310356 0
University of Southern Queensland
Country [2] 310356 0
Australia
Primary sponsor type
Individual
Name
Stephanie Frade
Address
USQ Ipswich Campus, 11 Salisbury Rd, Ipswich QLD 4305
Country
Australia
Secondary sponsor category [1] 311493 0
None
Name [1] 311493 0
Address [1] 311493 0
Country [1] 311493 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310011 0
University of Southern Queensland research ethics committee
Ethics committee address [1] 310011 0
USQ Ipswich Campus, 11 Salisbury Rd, Ipswich QLD 4305
Ethics committee country [1] 310011 0
Australia
Date submitted for ethics approval [1] 310011 0
15/09/2021
Approval date [1] 310011 0
23/09/2021
Ethics approval number [1] 310011 0
H21REA052

Summary
Brief summary
This study is a single-group pilot intervention that aims to evaluates the feasibility, satisfaction, and effectiveness of an 8-week, one-on-one telehealth-supervised exercise program for people with Systemic Lupus Erythematosus (SLE). It is hypothesised that fatigue, quality of life, and muscular strength will improve following the program, however, it is unknown whether participants will be satisfied with the telehealth-supervised exercise program and willing to continue with this type of program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116178 0
Mrs stephanie frade
Address 116178 0
USQ Ipswich Campus, 11 Salisbury Rd, Ipswich QLD 4305
Country 116178 0
Australia
Phone 116178 0
+61412567110
Fax 116178 0
Email 116178 0
u1124490@umail.usq.edu.au
Contact person for public queries
Name 116179 0
Mrs Stephanie Frade
Address 116179 0
USQ Ipswich Campus, 11 Salisbury Rd, Ipswich QLD 4305
Country 116179 0
Australia
Phone 116179 0
+61412567110
Fax 116179 0
Email 116179 0
u1124490@umail.usq.edu.au
Contact person for scientific queries
Name 116180 0
Mrs Stephanie Frade
Address 116180 0
USQ Ipswich Campus, 11 Salisbury Rd, Ipswich QLD 4305
Country 116180 0
Australia
Phone 116180 0
+61412567110
Fax 116180 0
Email 116180 0
u1124490@umail.usq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No - IPD will not be available


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
SourceTitleYear of PublicationDOI
EmbaseTelehealth-supervised exercise in systemic lupus erythematosus: A pilot study.2023https://dx.doi.org/10.1177/09612033231157073
N.B. These documents automatically identified may not have been verified by the study sponsor.