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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05710003
Other study ID # breathing exercises pregnancy
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date December 1, 2023

Study information

Verified date January 2023
Source Assiut University
Contact Entsar Hsanen, university lecturer
Phone 01019968106
Email entsar.hsanen@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea


Description:

Pregnant women undergo various anatomical and physiological changes so that they can cope with the increased physical and metabolic demands of their pregnancies. Cardiovascular, respiratory, haematological, renal, gastrointestinal and endocrine systems undergo important physiological adaptations needed to allow development of the fetus and to allow the mother and fetus to survive the demands of childbirth . On the other hand, dyspnea can be caused by pregnancy complications, thus requiring specific medical treatment. Shortness of breath is common during pregnancy, occurring in 60% to 70% of healthy pregnant women . The aim of the study is to evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 28
Est. completion date December 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 1. Inclusion criteria: pregnant women presented with physiological dyspnea. 2. Exclusion criteria: 1. Non physiological causes of dyspnea in pregnancy - Cardiac: arrhythmia, constrictive pericarditis , pericardial effusion , coronary heart disease , congestive heart failure , intracardiac shunt , cardiomyopathy , valvular heart disease. - Chest wall, pleura, lungs: bronchial asthma, bronchiectasis ,bronchiolitis ,chronic obstructive pulmonary disease, pulmonary emphysema, interstitial lung disease, sarcoidosis ,lung tumor narrowing or compressing the airways , pleural effusion , pulmonary right-to-left shunt , pulmonary hypertension ,elevated hemi diaphragm, phrenic nerve palsy, kyphoscoliosis - CNS and neuromuscular: amyotrophic lateral sclerosis , mitochondrial disease polymyositis/ dermatomyositis - Metabolic: renal failure , thyroid disease - Head and neck : laryngeal tumor ,vocal cord paralysis , vocal cord dysfunction , tumor compressing the upper airways , tracheal stenosis , goiter - Others: anemia , anxiety disorder, panic attacks, , ascites , obesity, abdominal wall hernia 2. Refusal to participate

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
breathing exercises
A-breathing exercises: 20 times per hour. While setting down, deep breathing is taken from the nose while mouth is closed, breath holding for at least ten seconds, then slow maximal exhalation for at least 10 seconds. B-Upper Limb Endurance Exercises (low weight and high repetition) : Study participants will be educated to perform upper limb exercises every 4 hours. Three exercises will be repeated 10×3 times with 1 minute rest in between. Breathing exercise and upper limb endurance exercises is explained in the reminder in details

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Entsar Hsanen

References & Publications (3)

Hegewald MJ, Crapo RO. Respiratory physiology in pregnancy. Clin Chest Med. 2011 Mar;32(1):1-13. doi: 10.1016/j.ccm.2010.11.001. — View Citation

Lee SY, Chien DK, Huang CH, Shih SC, Lee WC, Chang WH. Dyspnea in pregnancy. Taiwan J Obstet Gynecol. 2017 Aug;56(4):432-436. doi: 10.1016/j.tjog.2017.04.035. — View Citation

Melzer K, Schutz Y, Boulvain M, Kayser B. Physical activity and pregnancy: cardiovascular adaptations, recommendations and pregnancy outcomes. Sports Med. 2010 Jun 1;40(6):493-507. doi: 10.2165/11532290-000000000-00000. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Modified dyspnea Borg scale Modified Borg Dyspnea Scale is most commonly used to assess symptoms of breathlessness. It has a range from 0 to 10 (with 0 being no exertion and 10 being maximum effort). 4 weeks
Secondary Modified Medical Research Council Dyspnea Scale (mMRC) allows the patients to indicate the extent to which their breathlessness affects their mobility.
The 1-5 stage scale is used alongside the questionnaire to establish clinical grades of breathlessness.
4 weeks
Secondary London chest activity of Daily Living questionnaire (LCADL) It consist of four domains Selfcare, domestic activities, physical activities and leisure activities.
Selfcare, domestic, physical and leisure activities contains 4, 6, 2 and 3 items respectively. Each item is graded by numbers 0-5, 0 mean little or no dyspnea and 5 mean worst dyspnea
4 weeks
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