ISRCTN91200867已完成未知
The effect of an 8-week specialized physiotherapy program on sexual dysfunctions of female patients with systemic sclerosis and idiopathic inflammatory myopathies: a pilot study
Revmatologický Ústav0 个研究点目标入组 12 人开始时间: 2021年5月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37221419/ results (added 24/05/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. An Independent Ethics Committee approved written Informed Consent form is signed and dated by the subject
- •2. Subject is considered reliable and capable of adhering to the protocol and visit schedule
- •3. Subject is female at least 18 years of age
- •4. Subject fulfilled the 2013 EULAR/ACR classification criteria for systemic sclerosis or Bohan/Peter 1975 criteria for polymyositis/dermatomyositis
- •6. Subject is regularly followed at our out-patient department and adheres to the standard-of-care pharmacological therapy indicated by his treating rheumatologist
- •7. Subject is willing to participate in the study and undergo all planned examinations
- •8. Subject reported low sexual function at least in two of three questionnaires assessing sexual function: Female Sexual Function Index (FSFI), Brief Index of Sexual Functioning for Women (BISF-W), Sexual Function Questionnaire (SFQ-28). Low sexual function in FSFI and SFQ-28 was established based on diagnostic cut-off scores, and in BISF-W, sexual dysfunction was determined based on the 15th percentile obtained from a comparison of healthy control scores of the same age
排除标准
- •1. Subject has any other condition, including medical or psychiatric, which in the investigator's judgment would make the subject unsuitable for inclusion in the study
研究者
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