Sleep Quality, Stress, Depression, Blood Pressure Responses to Diaphragmatic Respiratory Exercise in Systemic Sclerosis
Sleep Quality, Stress/Depression, Autonomic Responses to Breathing Exercise in Systemic Sclerosis
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2022
CompletedFirst Submitted
Initial submission to the registry
November 14, 2022
CompletedFirst Posted
Study publicly available on registry
November 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2023
CompletedNovember 21, 2022
November 1, 2022
5 months
November 14, 2022
November 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
cortisol
a hormone that is usually represents as a stress hormone
12 weeks
Secondary Outcomes (8)
systolic blood pressure
12 weeks
diastolic blood pressure
12 weeks
pulse rate
12 weeks
respiratory rate
12 weeks
Patient Health Questionnaire
12 weeks
- +3 more secondary outcomes
Study Arms (2)
Exercised group
EXPERIMENTALthe 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).
control group
NO INTERVENTIONhe females in the this group will be waiting-list control females who will receive no training.
Interventions
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).
Eligibility Criteria
You may qualify if:
- systemic sclerosis women (40 females)
You may not qualify if:
- obesity
- thoracic diseases
- heart disease
- females with mental diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo Unoversity
Giza, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Ismail, lecturer
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
Study Record Dates
First Submitted
November 14, 2022
First Posted
November 21, 2022
Study Start
October 15, 2022
Primary Completion
March 15, 2023
Study Completion
March 15, 2023
Last Updated
November 21, 2022
Record last verified: 2022-11