EXCEL: EXamining the feasibility of exerCisE to manage symptoms of Lupus

Not Applicable

• Conditions: Systemic lupus erythematosus; Musculoskeletal Diseases

• Registration Number: ISRCTN72757645
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-10
• Last Update Posted: 8 July 2024
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

Patients:
1. Age >18 years old
2. Female patients with SLE (fulfilling classification criteria [1997 ACR, 2012 SLICC or 2019 EULAR/ACR). Note: approximately 90% of people suffering with SLE are female, hence this inclusion criteria
3. Clinically stable disease activity as assessed by a member of the medical team and deemed eligible for inclusion if they have no A or B scores in the BILAG-2004 index
4. Both participant and physician feel that they are able to exercise safely (PAR-Q screening)
5. Consent: demonstrates an understanding of the study and willingness to participate, as evidenced by voluntary written informed consent

Healthy controls:
1. Age: >18 years old
2. Female

National online survey:
1. Age: >18 years old
2. Female patients with SLE (fulfilling classification criteria [1997 ACR, 2012 SLICC or 2019 EULAR/ACR). Note: approximately 90% of people suffering with SLE are female, hence this inclusion criteria
3. Clinically stable disease activity as assessed by a member of the medical team and deemed eligible for inclusion if they have no A or B scores in the BILAG-2004 index
4. Both participant and physician feel that they are able to exercise safely (PAR-Q screening)
5. Consent: demonstrates an understanding of the study and willingness to participate, as evidenced by voluntary written informed consent

Exclusion Criteria

Exclusion criteria for exercise intervention:
1. Increase in the dosage of current lupus-specific medications (e.g., steroids, anti-malarial medications and/or immunosuppressants) within the last 3 months
2. Addition of new lupus-specific medications (e.g., steroids, anti-malarial medications and/or immunosuppressants) within the last 3 months
3. Patients with inactive disease but in whom there is a planned change in medication
4. Uncontrolled blood pressure
5. Pregnancy or planning pregnancy
6. Undertaking over 60 minutes of structured exercise per week
7. Additional health conditions or medication that might put the participant at risk or interfere with a participant’s capacity to exercise will be at the PI’s discretion, e.g., kidney or heart complications
8. Not owning a smart device or having no data plan or access to WiFi
9. Unable to provide full informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Feasibility of the personalised exercise plan will be evaluated by quantifying recruitment, adherence, and completion rates throughout the 12-week intervention (patient exercise group only)<br>2. Acceptability of the personalised exercise plan will be evaluated using a questionnaire after completion (patient exercise group only)