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Clinical Trials/ISRCTN72757645
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

niversity of Birmingham0 sites45 target enrollmentJanuary 10, 2024

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.

Registry
who.int
Start Date
January 10, 2024
End Date
March 31, 2025
Last Updated
last year
Study Type
Interventional
Sex
Female

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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