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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05623917
Enrollment
40
Registered
2022-11-21
Start date
2022-10-15
Completion date
2023-03-15
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

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.

Interventions

BEHAVIORALTele-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).

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* systemic sclerosis women (40 females)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
cortisol12 weeksa hormone that is usually represents as a stress hormone

Secondary

MeasureTime frameDescription
fatigue using visual analogue scale12 weeksit will be measured using visual analogue scale
systolic blood pressure12 weeksit will be measured by sphygmomanometer
diastolic blood pressure12 weeksit will be measured by sphygmomanometer
Pittsburgh Sleep Quality Index12 weeksit will measured the sleeping quality of females
respiratory rate12 weeksrate of respiration per minute
Patient Health Questionnaire12 weeksit contains eight questions. it will used to assess depression
Hamilton Anxiety Rating Scale12 weeksa psychological questionnaire used to assess psychological satus
pulse rate12 weeksrate of pulse per minute

Countries

Egypt

Contacts

Primary ContactAli Ismail, lecturer
ali.mohamed@pt.cu.edu.eg02 01005154209
Backup Contactahmed elfahl, Lecturer
ahmed.elfahl@buc.edu.eg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026