Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy

• Sponsor: Badr University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06031220
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.1
• Patients Per Site Per Month: 7.4

Study Details

Study Description

Brief Summary

this study is to investigate the response of pulmonary function to deep breathing exercise in twin pregnancy

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related	Other: deep breathing exercise inform of diaphragmatic and costal breathing	N/A

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 pregnant women 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 A: 30 women with twin pregnancy and group B: 30 women with singleton pregnancy (during the third trimester in both groups (27th weeks gestation), both groups 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy
• Actual Study Start Date: Oct 1, 2022
• Actual Primary Completion Date: May 30, 2023
• Actual Study Completion Date: Jun 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group 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.	Other: deep breathing exercise inform of diaphragmatic and costal breathing; deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks,
No Intervention: control group 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.

Outcome Measures

Primary Outcome Measures

1. forced vital capacity (FVC) [FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)]

   inspiratory reserve volume + tidal volume+ expiratory reserve volume

2. Forced Expiratory Volume in 1 Sec (FEV1) [FEV1 will be applied at 27th week gestation and at 36th weeks gestation (3 months)]

   Pulmonary Function Tests: (Forced Expiratory Volume in 1 Sec)

3. FEV1/FVC [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soaad kafafy university hospital	Giza		Egypt

Sponsors and Collaborators

• Badr University

Investigators

• Study Chair: Radwa S Mahmoud, PhD, Ass. Prof. Dept of PT for pediatrics, Faculty of PT, Cairo University and BUC
• Study Chair: Shimaa HA roshdy, PhD, Lecturer of PT Dept of PT for cardiopulmonary and geriatric, Faculty of PT, MUST
• Study Chair: Ayman A Elsallamy, PhD, Lecturer of obstetrics and gynecology, Ob/ GYN dept MUST
• Study Chair: Doaa S Mohamed El-sayed, PhD, Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC
• Study Chair: Mina AG Elias, PhD, Lecturer of PT, Dept. of PT for internal medicine and geriatric, Faculty of PT, BUC
• Principal Investigator: Noha A Fouad, PhD, Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Noha Ahmed Fouad Abd-Elrahman, lecturer of physical therapy for women health, Badr University
• ClinicalTrials.gov Identifier: NCT06031220
• Other Study ID Numbers: P.T.REC/012/004052
• First Posted: Sep 11, 2023
• Last Update Posted: Sep 11, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 11, 2023