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临床试验/NCT05623917
NCT05623917招募中不适用

Sleep Quality, Stress/Depression, Autonomic Responses to Breathing Exercise in Systemic Sclerosis

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
cortisol

研究概览

简要总结

systemic sclerosis women usually report problems such as stress/depression, fatigue, not deep sleep. complementary therapies may improve the reported problems in those patients

详细描述

the assignment of females with systemic sclerosis (n= forty females) to two equal groups. the group will contain 20 females. the first group will receive tele-supervised Diaphragmatic Respiratory Exercise ( applied at the homes of the females two times per the day, at the morning and at the evening, twenty minutes for every time, the sessions will be applied daily for 3 months in all females). the females in the second group will be waiting-list control females.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •systemic sclerosis women (40 females)

排除标准

  • •thoracic diseases
  • •heart disease
  • •females with mental diseases

研究组 & 干预措施

Exercised group

Experimental

the group will contain 20 females. the females will receive tele-supervised Diaphragmatic Respiratory Exercise ( applied at the homes of the females two times per the day, at the morning and at the evening, twenty minutes for every time, the sessions will be applied daily for 3 months in all females).

干预措施: Tele-supervised diaphragmatic respiratory exercise (Behavioral)

control group

No Intervention

he females in the this group will be waiting-list control females who will receive no training.

结局指标

主要结局

cortisol

时间窗: 12 weeks

a hormone that is usually represents as a stress hormone

次要结局

  • fatigue using visual analogue scale(12 weeks)
  • Pittsburgh Sleep Quality Index(12 weeks)
  • respiratory rate(12 weeks)
  • systolic blood pressure(12 weeks)
  • diastolic blood pressure(12 weeks)
  • pulse rate(12 weeks)
  • Patient Health Questionnaire(12 weeks)
  • Hamilton Anxiety Rating Scale(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Mohamed Ali ismail

lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Cairo University

研究点 (1)

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