Effect of Breathing Exercises and Upper Limb Endurance Exercises in Pregnant Women Presented With Physiological Dyspnea

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related; Dyspnea
• Intervention / Treatment: Behavioral: breathing exercises

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Entsar Hsanen, university lecturer; Phone Number: 01019968106; Email: entsar.hsanen@aun.edu.eg
• Study Contact Backup: Name: Mohammed Gamal, university lecturer; Phone Number: 01026600071; Email: dr.mga2011@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Entsar Hsanen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (ACTUAL): February 2, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: breathing exercises; pregnancy; dyspnea
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Aspiration; Dyspnea
• Other Study ID Numbers: breathing exercises pregnancy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No