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
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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