ISRCTN72757645
Active, not recruiting
未知
Examining the feasibility and acceptability of a remotely monitored exercise intervention on clinical, immunological and psychological aspects of health in patients with systemic lupus erythematosus
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Systemic lupus erythematosus
- Sponsor
- niversity of Birmingham
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
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
Outcomes
Primary Outcomes
Not specified
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