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

Study Overview
=================
Brief 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

Detailed 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.

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

Conditions
-----------------
Systemic Sclerosis

Intervention / Treatment
-----------------
* Behavioral: Tele-supervised diaphragmatic respiratory exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: systemic sclerosis women (40 females) Exclusion Criteria: obesity thoracic diseases heart disease females with mental diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercised group<br>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). | Behavioral: Tele-supervised diaphragmatic respiratory exercise<br>* 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).<br>|
| No Intervention: control group<br>he females in the this group will be waiting-list control females who will receive no training. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cortisol | a hormone that is usually represents as a stress hormone | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure | it will be measured by sphygmomanometer | 12 weeks | 
| diastolic blood pressure | it will be measured by sphygmomanometer | 12 weeks | 
| pulse rate | rate of pulse per minute | 12 weeks | 
| respiratory rate | rate of respiration per minute | 12 weeks | 
| Patient Health Questionnaire | it contains eight questions. it will used to assess depression | 12 weeks | 
| Hamilton Anxiety Rating Scale | a psychological questionnaire used to assess psychological satus | 12 weeks | 
| fatigue using visual analogue scale | it will be measured using visual analogue scale | 12 weeks | 
| Pittsburgh Sleep Quality Index | it will measured the sleeping quality of females | 12 weeks |