Back to resultsEffect of Breathing Exercises and Upper Limb Endurance Exercises in Pregnant Women Presented With Physiological Dyspnea
Primary Purpose
Pregnancy Related, Dyspnea
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
breathing exercises
Sponsored by
About this trial
This is an interventional supportive care trial for Pregnancy Related focused on measuring dyspnea, breathing exercises, pregnancy
Eligibility Criteria
Inclusion criteria: pregnant women presented with physiological dyspnea. Exclusion criteria: 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 Refusal to participate
Sites / Locations
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05710003
Brief Title
Effect of Breathing Exercises and Upper Limb Endurance Exercises in Pregnant Women Presented With Physiological Dyspnea
Official Title
Effect of Breathing Exercises and Upper Limb Endurance Exercises in Pregnant Women Presented With Physiological Dyspnea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Entsar Hsanen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Dyspnea
Keywords
dyspnea, breathing exercises, pregnancy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study will include pregnant ladies presented to respiratory outpatient clinic with physiological dyspnea at the third trimester of pregnancy
Masking
None (Open Label)
Masking Description
single group pf patients and follow up effect of breathing exercises and upper limb exercises in perceived dyspnea and quality of life(fatigue scores)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
breathing exercises
Other Intervention Name(s)
upper limb endurance exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Modified dyspnea Borg scale
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Modified Medical Research Council Dyspnea Scale (mMRC)
Description
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.
Time Frame
4 weeks
Title
London chest activity of Daily Living questionnaire (LCADL)
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: pregnant women presented with physiological dyspnea.
Exclusion criteria:
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
Refusal to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Entsar Hsanen, university lecturer
Phone
01019968106
Email
entsar.hsanen@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Gamal, university lecturer
Phone
01026600071
Email
dr.mga2011@aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28805596
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.
Results Reference
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PubMed Identifier
21277444
Citation
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.
Results Reference
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PubMed Identifier
20524714
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.
Results Reference
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Effect of Breathing Exercises and Upper Limb Endurance Exercises in Pregnant Women Presented With Physiological Dyspnea
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