跳至主要内容
临床试验/ISRCTN72757645
ISRCTN72757645进行中(未招募)Unknown

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 个研究点目标入组 45 人开始时间: 2024年1月10日最近更新:
适应症

试验速览

阶段
Unknown
状态
进行中(未招募)
入组人数
45

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
Female

入选标准

  • 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
  • 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

排除标准

  • 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

研究者

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