Sleep Quality, Stress, Depression, Blood Pressure Responses to Diaphragmatic Respiratory Exercise in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623917
• Other study ID #: P.T.REC/012/004115
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: Ali Ismail, lecturer
• Phone: 02 01005154209
• Email: ali.mohamed[@]pt.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• systemic sclerosis women (40 females)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Behavioral:
• Tele-supervised diaphragmatic respiratory exercise
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).

Locations

Country	Name	City	State
Egypt	Cairo Unoversity	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cortisol	a hormone that is usually represents as a stress hormone	12 weeks
Secondary	systolic blood pressure	it will be measured by sphygmomanometer	12 weeks
Secondary	diastolic blood pressure	it will be measured by sphygmomanometer	12 weeks
Secondary	pulse rate	rate of pulse per minute	12 weeks
Secondary	respiratory rate	rate of respiration per minute	12 weeks
Secondary	Patient Health Questionnaire	it contains eight questions. it will used to assess depression	12 weeks
Secondary	Hamilton Anxiety Rating Scale	a psychological questionnaire used to assess psychological satus	12 weeks
Secondary	fatigue using visual analogue scale	it will be measured using visual analogue scale	12 weeks
Secondary	Pittsburgh Sleep Quality Index	it will measured the sleeping quality of females	12 weeks