Pregnancy RelatedNCT06031220
Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy
A study testing deep breathing exercise inform of diaphragmatic and costal breathing in people with Pregnancy Related, run by Badr University at 1 site in Egypt.
Trial summary
this study is to investigate the response of pulmonary function to deep breathing exercise in twin pregnancy Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- deep breathing exercise inform of diaphragmatic and costal breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 5 Jun 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All pregnant women will be in 27th week gestation
- They will be recruited from Soaad kafafy university hospital
- Their age between 25-35 years old
- Their BMI ≥30Kg/m2
Who cannot join
- Pregnant women with any pulmonary disorders before pregnancy
- Women suffering from any physical or mental disorders.
- Pregnant women with gestational diabetes
- Pregnant women with gestational hypertension
- Pregnant women with asthma
Trial locations and contacts
1 site in 1 country.
About this study
this study is to investigate the response of pulmonary function to deep breathing exercise in twin pregnancy
Read the detailed description
Physiological changes during pregnancy impose numerous changes on the respiratory system that can affect the health of both mother and foetus. Regarding the importance of the normal breathing in the health of mother and foetus.
Many investigators have studied pulmonary function tests during normal pregnancy, most of them found a significant decrease in pulmonary function test parameters during all pregnancy trimesters. Others showed that the PFTs parameters are normal in the first trimester but there was significant decrease in them in the second and third trimesters, or in the third trimester only.
Study Design: Randomized control trial Sixty twin pregnant women during the third trimester i (27th weeks gestation),aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into two equal groups; control group and study group ( study group only will make deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks, pulmonary function test will be applied for both groups at 27th week gestation and at 36th weeks gestation.
- Conditions
- Pregnancy Related
- Being tested
- deep breathing exercise inform of diaphragmatic and costal breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep breathing exercise inform of diaphragmatic and costal breathingOther
deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks,
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 30 women with twin pregnancy during the third trimester at 27th weeks gestation will make deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks, pulmonary function test will be applied at 27th week gestation and at 36th weeks gestation. Receives: Other: deep breathing exercise inform of diaphragmatic and costal breathing |
| control group | No intervention | 30 women with twin pregnancy during the third trimester at 27th weeks gestation will not receive any special treatment and will be assessed with pulmonary function test at 27th week gestation and at 36th weeks gestation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced vital capacity (FVC)
inspiratory reserve volume + tidal volume+ expiratory reserve volume
Measured: FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
Forced Expiratory Volume in 1 Sec (FEV1)
Pulmonary Function Tests: (Forced Expiratory Volume in 1 Sec)
Measured: FEV1 will be applied at 27th week gestation and at 36th weeks gestation (3 months)
FEV1/FVC
ratio between Forced Expiratory Volume in 1 Sec (FEV1) and forced vital capacity (FVC)
Measured: FEV1/FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Oct 2022
- Primary completion30 May 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ahmed Fouad Abd-Elrahman, Badr University
- Investigators
- Radwa S Mahmoud, PhD, Study chair, Ass. Prof. Dept of PT for pediatrics, Faculty of PT, Cairo University and BUCShimaa HA roshdy, PhD, Study chair, Lecturer of PT Dept of PT for cardiopulmonary and geriatric, Faculty of PT, MUSTAyman A Elsallamy, PhD, Study chair, Lecturer of obstetrics and gynecology, Ob/ GYN dept MUSTDoaa S Mohamed El-sayed, PhD, Study chair, Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUCMina AG Elias, PhD, Study chair, Lecturer of PT, Dept. of PT for internal medicine and geriatric, Faculty of PT, BUCNoha A Fouad, PhD, Principal investigator, Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031220
- Sponsor's protocol ID
- P.T.REC/012/004052
- Status last verified
- Nov 2023
- First submitted
- 3 Sep 2023
- Last updated
- 22 Nov 2023
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy
- ClinicalTrials.gov ID
- NCT06031220
- Acronym / sponsor ID
- P.T.REC/012/004052
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 11 Sep 2023 (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.
this study is to investigate the response of pulmonary function to deep breathing exercise in twin pregnancy
Detailed description
Physiological changes during pregnancy impose numerous changes on the respiratory system that can affect the health of both mother and foetus. Regarding the importance of the normal breathing in the health of mother and foetus.
Many investigators have studied pulmonary function tests during normal pregnancy, most of them found a significant decrease in pulmonary function test parameters during all pregnancy trimesters. Others showed that the PFTs parameters are normal in the first trimester but there was significant decrease in them in the second and third trimesters, or in the third trimester only.
Study Design: Randomized control trial Sixty twin pregnant women during the third trimester i (27th weeks gestation),aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into two equal groups; control group and study group ( study group only will make deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks, pulmonary function test will be applied for both groups at 27th week gestation and at 36th weeks gestation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: deep breathing exercise inform of diaphragmatic and costal breathing30 women with twin pregnancy during the third trimester at 27th weeks gestation will make deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks, pulmonary function test will be applied at 27th week gestation and at 36th weeks gestation. |
| control group | No intervention | –30 women with twin pregnancy during the third trimester at 27th weeks gestation will not receive any special treatment and will be assessed with pulmonary function test at 27th week gestation and at 36th weeks gestation. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All pregnant women will be in 27th week gestation
- They will be recruited from Soaad kafafy university hospital
- Their age between 25-35 years old
- Their BMI ≥30Kg/m2
Key exclusion criteria (5 listed)
- Pregnant women with any pulmonary disorders before pregnancy
- Women suffering from any physical or mental disorders.
- Pregnant women with gestational diabetes
- Pregnant women with gestational hypertension
- Pregnant women with asthma
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 |
|---|---|---|
| deep breathing exercise inform of diaphragmatic and costal breathingdeep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks, | Other | study group |
Primary outcome
forced vital capacity (FVC)
Time frame: FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
inspiratory reserve volume + tidal volume+ expiratory reserve volume
Forced Expiratory Volume in 1 Sec (FEV1)
Time frame: FEV1 will be applied at 27th week gestation and at 36th weeks gestation (3 months)
Pulmonary Function Tests: (Forced Expiratory Volume in 1 Sec)
FEV1/FVC
Time frame: FEV1/FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
ratio between Forced Expiratory Volume in 1 Sec (FEV1) and forced vital capacity (FVC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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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.
Radwa S Mahmoud, PhD study chair
Ass. Prof. Dept of PT for pediatrics, Faculty of PT, Cairo University and BUC
Shimaa HA roshdy, PhD study chair
Lecturer of PT Dept of PT for cardiopulmonary and geriatric, Faculty of PT, MUST
Ayman A Elsallamy, PhD study chair
Lecturer of obstetrics and gynecology, Ob/ GYN dept MUST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep breathing exercise inform of diaphragmatic and costal breathing in people with Pregnancy Related, run by Badr 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 22 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced vital capacity (FVC) (time frame: FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)). The study lists 3 primary outcomes in all. 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 22 Nov 2023.