Primary Open Angle GlaucomaNCT05605743
Alternate Nostril Breathing Training in Geriatrics With Glaucoma and High Blood Pressure
A study testing breathing exercise in people with Primary Open Angle Glaucoma and Hypertension, run by Cairo University at 1 site in Egypt.
Trial summary
Hypertension, particularly if poorly controlled, appears related to an increased risk of open angle glaucoma, (the high tension type of glaucoma is characterized as optic nerve degeneration with ocular hypertension). so this study will search response of glaucoma to breathing exercise Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Hypertension
- What is being tested?
- breathing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2022to 15 Jan 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- hypertensive elderly
- primary open angle glaucoma in both eyes
- ocular hypertension in both eyes
Who cannot join
- acute or chronic eye inflammation cataract eye surgeries mental ill patients patients who will refuse to participate in the study other systemic /cardiovascular problem
Trial locations and contacts
1 site in 1 country.
mona taha, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Giza, Dokki
Ali Ismail, lecturer, 02 01005154209, allooka2012@gmail.com
About this study
Official title: Ocular Hypertension Response to Alternate Nostril Breathing Training in Geriatrics With Glaucoma and High Blood Pressure
Hypertension, particularly if poorly controlled, appears related to an increased risk of open angle glaucoma, (the high tension type of glaucoma is characterized as optic nerve degeneration with ocular hypertension). so this study will search response of glaucoma to breathing exercise
Read the detailed description
Hypertension, particularly if poorly controlled, appears related to an increased risk of open angle glaucoma, (the high tension type of glaucoma is characterized as optic nerve degeneration with ocular hypertension). With a random assignment, sixty hypertensive geriatric with high tension type primary open angle glaucoma will be assigned to breathing exercise (alternate nostril breathing) group (n=30 geriatrics) or waiting list geriatrics. the daily breathing exercise will be performed by the geriatrics in evening (for half an hour) and morning (for half an hour).
- Conditions
- Primary Open Angle Glaucoma, Hypertension
- Being tested
- breathing exercise
- Medical subject headings
- Glaucoma, Open-Angle, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing exerciseBehavioural
Thirty hypertensive geriatric with high tension type primary open angle glaucoma will perform breathing exercise (alternate nostril breathing). The daily breathing exercise will be performed by the geriatrics in evening (for half an hour) and morning (for half an hour) for one month.
| Study group | Role | What they receive |
|---|---|---|
| Exercised group | Experimental | Thirty hypertensive geriatric with high tension type primary open angle glaucoma will perform breathing exercise (alternate nostril breathing). The daily breathing exercise will be performed by the geriatrics in evening (for half an hour) and morning (for half an hour) for one month. Receives: Behavioral: breathing exercise |
| control group | No intervention | this will be a thirty-patient wait-list group that will no receive any shape of training |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoccular pressure
it will be measured in right and left eyes
Measured: It will be measured after 4 weeks of training
Secondary outcomes (7)
systolic blood pressure
it will be measured sphygmomanometer
Measured: It will be measured after 4 weeks of training
diastolic blood pressure
it will be measured sphygmomanometer
Measured: It will be measured after 4 weeks of training
heart rate
it will be measured manually
Measured: It will be measured after 4 weeks of training
respiratory rate
it will be measured manually
Measured: It will be measured after 4 weeks of training
hospital anxiety and depression scale
it contains fourteen questions. it contains two sub-scales, one for anxiety and the other for depression
Measured: It will be measured after 4 weeks of training
short form 36 survey
in general, it will assess life quality
Measured: It will be measured after 4 weeks of training
glaucoma quality of life-15 questionnaire
it will assess glaucoma-related life quality
Measured: It will be measured after 4 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start15 Sep 2022
- Primary completion15 Jan 2023 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies 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
- 60 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
- NCT05605743
- Sponsor's protocol ID
- P.T.REC/012/004006
- Status last verified
- Oct 2022
- First submitted
- 30 Oct 2022
- Last updated
- 4 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 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Hypertension Response to Alternate Nostril Breathing Training in Geriatrics With Glaucoma and High Blood Pressure
- ClinicalTrials.gov ID
- NCT05605743
- Acronym / sponsor ID
- P.T.REC/012/004006
- Conditions
- Primary Open Angle Glaucoma, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 4 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.
Hypertension, particularly if poorly controlled, appears related to an increased risk of open angle glaucoma, (the high tension type of glaucoma is characterized as optic nerve degeneration with ocular hypertension). so this study will search response of glaucoma to breathing exercise
Detailed description
Hypertension, particularly if poorly controlled, appears related to an increased risk of open angle glaucoma, (the high tension type of glaucoma is characterized as optic nerve degeneration with ocular hypertension). With a random assignment, sixty hypertensive geriatric with high tension type primary open angle glaucoma will be assigned to breathing exercise (alternate nostril breathing) group (n=30 geriatrics) or waiting list geriatrics. the daily breathing exercise will be performed by the geriatrics in evening (for half an hour) and morning (for half an hour).
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: breathing exerciseThirty hypertensive geriatric with high tension type primary open angle glaucoma will perform breathing exercise (alternate nostril breathing). The daily breathing exercise will be performed by the geriatrics in evening (for half an hour) and morning (for half an hour) for one month. |
| control group | No intervention | –this will be a thirty-patient wait-list group that will no receive any shape of training |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- hypertensive elderly
- primary open angle glaucoma in both eyes
- ocular hypertension in both eyes
Key exclusion criteria (1 listed)
- acute or chronic eye inflammation cataract eye surgeries mental ill patients patients who will refuse to participate in the study other systemic /cardiovascular problem
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 |
|---|---|---|
| breathing exerciseThirty hypertensive geriatric with high tension type primary open angle glaucoma will perform breathing exercise (alternate nostril breathing). The daily breathing exercise will be performed by the geriatrics in evening (for half an hour) and morning (for half an hour) for one month. | Behavioural | Exercised group |
Primary outcome
intraoccular pressure
Time frame: It will be measured after 4 weeks of training
it will be measured in right and left eyes
7 secondary outcomes
systolic blood pressure
Time frame: It will be measured after 4 weeks of training
diastolic blood pressure
Time frame: It will be measured after 4 weeks of training
heart rate
Time frame: It will be measured after 4 weeks of training
respiratory rate
Time frame: It will be measured after 4 weeks of training
hospital anxiety and depression scale
Time frame: It will be measured after 4 weeks of training
short form 36 survey
Time frame: It will be measured after 4 weeks of training
glaucoma quality of life-15 questionnaire
Time frame: It will be measured after 4 weeks of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 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.
mona taha, professor 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 breathing exercise in people with Primary Open Angle Glaucoma and Hypertension, 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 3 inclusion and 1 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 4 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?
intraoccular pressure (time frame: It will be measured after 4 weeks of training). 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 4 Nov 2022.