Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-28 @ 8:18 PM
Study NCT ID:
NCT05710003
Status:
UNKNOWN
Last Update Posted:
2023-02-02
First Post:
2023-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Breathing Exercises and Upper Limb Endurance Exercises in Pregnant Women Presented With Physiological Dyspnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001945', 'term': 'Breathing Exercises'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'single group pf patients and follow up effect of breathing exercises and upper limb exercises in perceived dyspnea and quality of life(fatigue scores)'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study will include pregnant ladies presented to respiratory outpatient clinic with physiological dyspnea at the third trimester of pregnancy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-25', 'studyFirstSubmitDate': '2023-01-25', 'studyFirstSubmitQcDate': '2023-01-25', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified dyspnea Borg scale', 'timeFrame': '4 weeks', '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).'}], 'secondaryOutcomes': [{'measure': 'Modified Medical Research Council Dyspnea Scale (mMRC)', 'timeFrame': '4 weeks', 'description': 'allows the patients to indicate the extent to which their breathlessness affects their mobility.\n\nThe 1-5 stage scale is used alongside the questionnaire to establish clinical grades of breathlessness.'}, {'measure': 'London chest activity of Daily Living questionnaire (LCADL)', 'timeFrame': '4 weeks', 'description': 'It consist of four domains Selfcare, domestic activities, physical activities and leisure activities.\n\nSelfcare, 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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dyspnea', 'breathing exercises', 'pregnancy'], 'conditions': ['Pregnancy Related', 'Dyspnea']}, 'referencesModule': {'references': [{'pmid': '28805596', 'type': 'BACKGROUND', '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.'}, {'pmid': '21277444', 'type': 'BACKGROUND', '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.'}, {'pmid': '20524714', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '1. Inclusion criteria: pregnant women presented with physiological dyspnea.\n2. Exclusion criteria:\n\n 1. Non physiological causes of dyspnea in pregnancy\n\n * Cardiac: arrhythmia, constrictive pericarditis , pericardial effusion , coronary heart disease , congestive heart failure , intracardiac shunt , cardiomyopathy , valvular heart disease.\n * 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\n * CNS and neuromuscular: amyotrophic lateral sclerosis , mitochondrial disease polymyositis/ dermatomyositis\n * Metabolic: renal failure , thyroid disease\n * Head and neck : laryngeal tumor ,vocal cord paralysis , vocal cord dysfunction , tumor compressing the upper airways , tracheal stenosis , goiter\n * Others: anemia , anxiety disorder, panic attacks, , ascites , obesity, abdominal wall hernia\n 2. Refusal to participate'}, 'identificationModule': {'nctId': 'NCT05710003', 'briefTitle': 'Effect of Breathing Exercises and Upper Limb Endurance Exercises in Pregnant Women Presented With Physiological Dyspnea', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Breathing Exercises and Upper Limb Endurance Exercises in Pregnant Women Presented With Physiological Dyspnea', 'orgStudyIdInfo': {'id': 'breathing exercises pregnancy'}}, 'armsInterventionsModule': {'interventions': [{'name': 'breathing exercises', 'type': 'BEHAVIORAL', 'otherNames': ['upper limb endurance exercises'], '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.\n\nB-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.\n\nBreathing exercise and upper limb endurance exercises is explained in the reminder in details'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Entsar Hsanen, university lecturer', 'role': 'CONTACT', 'email': 'entsar.hsanen@aun.edu.eg', 'phone': '01019968106'}, {'name': 'Mohammed Gamal, university lecturer', 'role': 'CONTACT', 'email': 'dr.mga2011@aun.edu.eg', 'phone': '01026600071'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Entsar Hsanen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Entsar Hsanen', 'investigatorAffiliation': 'Assiut University'}}}}