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

November 18, 2022 updated by: Ali Mohamed Ali ismail, Cairo University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Cairo Unoversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • systemic sclerosis women (40 females)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercised group
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
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).
No Intervention: control group
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
Time Frame: 12 weeks
a hormone that is usually represents as a stress hormone
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2022

Primary Completion (Anticipated)

March 15, 2023

Study Completion (Anticipated)

March 15, 2023

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

November 18, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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