Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-30 @ 7:16 AM
Study NCT ID:
NCT03876834
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2019-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Training in Patients With Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, '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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum voluntary ventilation', 'timeFrame': 'change from baseline maximum voluntary ventilation at 4 weeks', 'description': 'It was performed by breathing deeply and rapidly for 10 to 15 seconds using spirometer'}, {'measure': '2 min walk test', 'timeFrame': 'change from baseline 2 min walk test at 4 weeks', 'description': 'Each patient was asked to cover as much ground as possible over 2 minutes'}, {'measure': 'FACT-G questionnaire', 'timeFrame': 'change from baseline FACT-G questionnaire at 4 weeks', 'description': '27 questions with four domains assessing physical well being,social well being, emotional well being and functional wellbeing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['leukemia', 'chemotherapy', 'respiratory training'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'Forty male leukemic patients receiving chemotherapy were selected from National Cancer Institute, They were randomly assigned into two groups. Group (A) included 30 patients who were trained by Inspiratory muscle trainer for 4 weeks ;5 sessions/week and Group (B) included 10 patients as a control group.\n\nThe following measures were taken before and after the study period : Maximum voluntary ventilation(MVV) , 2 min walk test, FACT-G questionnaire', 'detailedDescription': 'Forty male leukemic patients receiving chemotherapy for at least one cycle and their mean ages 37.1 ± 4.89 years.The patients were selected from National Cancer Institute, Cairo ( inpatient ward). The study lasted from March 2018 to June 2018. Patients were randomly assigned into two groups.Group A (30 patients) who received inspiratory muscles training for 4 successive weeks, 5 sessions/week; and Group B (10 patients) acted as a control group on chemotherapy only. Data obtained from both groups regarding (MVV), 2 min walk test and Quality of life questionnaire (FACT-G) were statistically analyzed and compared'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male patient with age ranges from 30-50 years\n* All patients were leukemic receiving chemotherapy for at least one cycle as a treatment of malignant tumor\n* All patients were hemodynamically stable\n* All patients were ambulant\n\nExclusion Criteria:\n\n* lung cancer\n* History of any pulmonary disease.\n* Metastasis of lungs, ribs, mediastinal structure\n* Pulmonary pathology(e.g acute respiratory distress syndrome or exacerbation of chronic obstructive pulmonary disease)\n* ruptured ear drum or any other condition of the ear\n* High peak airway pressure (barotraumas)\n* patients with marked elevated left ventricular end diastolic volume and pressure\n* patients with worsening heart failure signs and symptoms'}, 'identificationModule': {'nctId': 'NCT03876834', 'briefTitle': 'Respiratory Training in Patients With Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Influence of Respiratory Training on Functional Capacity in Patients With Leukemia', 'orgStudyIdInfo': {'id': '201617032.4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group (group A)', 'description': 'Group (A) included 30 leukemic patients receiving chemotherapy in addition to training by inspiratory muscle trainer(IMT) for 4 weeks, 5 sessions /week', 'interventionNames': ['Other: respiratory training']}, {'type': 'NO_INTERVENTION', 'label': 'control group (B)', 'description': 'Group (B) included 10 leukemic patients receiving chemotherapy only'}], 'interventions': [{'name': 'respiratory training', 'type': 'OTHER', 'description': 'Respiratory training was done by using threshold inspiratory muscle trainer(Respironics, New Jersey , USA, No.8373-0730)', 'armGroupLabels': ['study group (group A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12316', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Physical Therapy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Heba Ahmed Ali Abdeen', 'investigatorAffiliation': 'Cairo University'}}}}