search
Back to results

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

Primary Purpose

Systemic Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tele-supervised diaphragmatic respiratory exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo UnoversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercised group

control group

Arm Description

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).

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

Outcomes

Primary Outcome Measures

cortisol
a hormone that is usually represents as a stress hormone

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2022
Last Updated
November 18, 2022
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05623917
Brief Title
Sleep Quality, Stress, Depression, Blood Pressure Responses to Diaphragmatic Respiratory Exercise in Systemic Sclerosis
Official Title
Sleep Quality, Stress/Depression, Autonomic Responses to Breathing Exercise in Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
March 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercised group
Arm Type
Experimental
Arm Description
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).
Arm Title
control group
Arm Type
No Intervention
Arm Description
he females in the this group will be waiting-list control females who will receive no training.
Intervention Type
Behavioral
Intervention Name(s)
Tele-supervised diaphragmatic respiratory exercise
Intervention Description
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).
Primary Outcome Measure Information:
Title
cortisol
Description
a hormone that is usually represents as a stress hormone
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
systolic blood pressure
Description
it will be measured by sphygmomanometer
Time Frame
12 weeks
Title
diastolic blood pressure
Description
it will be measured by sphygmomanometer
Time Frame
12 weeks
Title
pulse rate
Description
rate of pulse per minute
Time Frame
12 weeks
Title
respiratory rate
Description
rate of respiration per minute
Time Frame
12 weeks
Title
Patient Health Questionnaire
Description
it contains eight questions. it will used to assess depression
Time Frame
12 weeks
Title
Hamilton Anxiety Rating Scale
Description
a psychological questionnaire used to assess psychological satus
Time Frame
12 weeks
Title
fatigue using visual analogue scale
Description
it will be measured using visual analogue scale
Time Frame
12 weeks
Title
Pittsburgh Sleep Quality Index
Description
it will measured the sleeping quality of females
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
based on self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: systemic sclerosis women (40 females) Exclusion Criteria: obesity thoracic diseases heart disease females with mental diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
ali.mohamed@pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed elfahl, Lecturer
Email
ahmed.elfahl@buc.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs