Systemic SclerosisNCT05623917
Sleep Quality, Stress, Depression, Blood Pressure Responses to Diaphragmatic Respiratory Exercise in Systemic Sclerosis
A study testing Tele-supervised diaphragmatic respiratory exercise in people with Systemic Sclerosis, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Tele-supervised diaphragmatic respiratory exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2022to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- systemic sclerosis women (40 females)
Who cannot join
- obesity
- thoracic diseases
- heart disease
- females with mental diseases
Trial locations and contacts
1 site in 1 country.
ahmed elfahl, Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unoversity
Giza
Ali Ismail, lecturer, 01005154209, allooka2012@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Systemic Sclerosis
- Being tested
- Tele-supervised diaphragmatic respiratory exercise
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-supervised diaphragmatic respiratory exerciseBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Exercised group | Experimental | 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). Receives: Behavioral: Tele-supervised diaphragmatic respiratory exercise |
| control group | No intervention | he females in the this group will be waiting-list control females who will receive no training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cortisol
a hormone that is usually represents as a stress hormone
Measured: 12 weeks
Secondary outcomes (8)
systolic blood pressure
it will be measured by sphygmomanometer
Measured: 12 weeks
diastolic blood pressure
it will be measured by sphygmomanometer
Measured: 12 weeks
pulse rate
rate of pulse per minute
Measured: 12 weeks
respiratory rate
rate of respiration per minute
Measured: 12 weeks
Patient Health Questionnaire
it contains eight questions. it will used to assess depression
Measured: 12 weeks
Hamilton Anxiety Rating Scale
a psychological questionnaire used to assess psychological satus
Measured: 12 weeks
fatigue using visual analogue scale
it will be measured using visual analogue scale
Measured: 12 weeks
Pittsburgh Sleep Quality Index
it will measured the sleeping quality of females
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start15 Oct 2022
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623917
- Sponsor's protocol ID
- P.T.REC/012/004115
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality, Stress/Depression, Autonomic Responses to Breathing Exercise in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05623917
- Acronym / sponsor ID
- P.T.REC/012/004115
- Conditions
- Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercised group | Experimental | Behavioral: Tele-supervised diaphragmatic respiratory exercisethe 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 intervention | –he females in the this group will be waiting-list control females who will receive no training. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- systemic sclerosis women (40 females)
Key exclusion criteria (4 listed)
- obesity
- thoracic diseases
- heart disease
- females with mental diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-supervised diaphragmatic respiratory exercisethe 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). | Behavioural | Exercised group |
Primary outcome
cortisol
Time frame: 12 weeks
a hormone that is usually represents as a stress hormone
8 secondary outcomes
systolic blood pressure
Time frame: 12 weeks
diastolic blood pressure
Time frame: 12 weeks
pulse rate
Time frame: 12 weeks
respiratory rate
Time frame: 12 weeks
Patient Health Questionnaire
Time frame: 12 weeks
Hamilton Anxiety Rating Scale
Time frame: 12 weeks
fatigue using visual analogue scale
Time frame: 12 weeks
Pittsburgh Sleep Quality Index
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed elfahl, Lecturer contact
Ali Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-supervised diaphragmatic respiratory exercise in people with Systemic Sclerosis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Ismail, lecturer (02 01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cortisol (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.