Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-07 @ 5:36 AM
Study NCT ID:
NCT04613050
Status:
COMPLETED
Last Update Posted:
2022-12-28
First Post:
2020-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Respiratory Versus Aerobic Training on Respiratory and Immunity Efficiency in Recovered COVID- 19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-24', 'studyFirstSubmitDate': '2020-10-30', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete blood picture', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'A venous blood sample will be taken to be analyzed in the laboratory'}, {'measure': 'Arterial blood gases', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'arterial blood sample will be assessed'}, {'measure': '6-minute walk Distance', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'patient will be instructed to walk as fast as long as possible, in a 30 meters obstacle- free corridor, limited by turnaround cones. Standardized verbal encouragement will be given every minute. After 6 min, patient will be instructed to stop, and the total distance will be measured, rounding to the nearest meter.'}, {'measure': 'Breath-hold test', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'A rough index of cardiopulmonary reserve measured by the length of time that a person can voluntarily stop breathing; normal duration is 30 seconds or longer; diminished cardiac or pulmonary reserve is indicated by a duration of 20 seconds or less.'}, {'measure': 'Oxygen saturation', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'Percentage of haemoglobin saturated with oxygen measured by pulse oximeter'}, {'measure': 'Borg Dyspnea Scale score', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'It is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during six minute walk test'}], 'secondaryOutcomes': [{'measure': 'Maximum oxygen consumption', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'Maximum oxygen consumption(VO2 max): Results of (6MWT) was used to calculate Vo2 max by using Cahalin equation as follows; Vo2 max = 0.03x distance in meters +3.98, in which distance is obtained from (6MWT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid 19 Infection']}, 'descriptionModule': {'briefSummary': 'This study will be conducted on eighty patients of both sexes with age ranging from 35 to 45years. The will be recovered from COVID-19 infection with chest symptoms. They will be selected from Nasr city police authority hospital. They will be randomly assigned into 3 equal groups.', 'detailedDescription': 'This study will be conducted on eighty patients of both sexes with age ranging from 35 to 45years. The will be recovered from COVID-19 infection with chest symptoms. They will be selected from Nasr city police authority hospital. They will be randomly assigned into 3 equal groups.\n\nParticipants will be assigned into 3 groups equal in number (group A, group B, group C)\n\nGroup A (Respiratory Training Group) : It will include 30 patients of both sexes, recovered from COVID-19 infection. In addition to medical drugs, they will receive respiratory training for 6 weeks.\n\nGroup B : (Aerobic Training Group) : It will include 30 patients of both sexes, recovered from COVID-19 infection. In addition to medical drugs, they will receive aerobic training for 6 weeks\n\nGroup C : (control group) :It will include 20 patients of both sexes, recovered from COVID-19 infection on medical drugs only will receive no exercise as control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients recovered from COVID -19 infection.\n* Patients with body mass index 25 - 35 kg/m2\n* Patients previously diagnosed with chest symptoms of COVID- 19 infection.\n* Patients' body temperature less than 37.5\n* Blood oxygen saturation ≥95%\n\nExclusion Criteria:\n\n* Smokers\n* Patients with Myocardial infarction\n* Patients with diabetes.\n* Patients with autoimmune disease.\n* Patients with positive COVID -19 infection.\n* Patients with previous chest diseases\n* a heart rate of \\>100 bpm\n* a blood pressure of \\<90/60 mmHg or \\>140/90 mmHg\n* a blood oxygen saturation of ≤95%\n* other diseases that are not suitable for exercise (osteoarthritis knee - stroke patients, etc)"}, 'identificationModule': {'nctId': 'NCT04613050', 'briefTitle': 'Effect of Respiratory Versus Aerobic Training on Respiratory and Immunity Efficiency in Recovered COVID- 19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Respiratory Versus Aerobic Training on Respiratory and Immunity Efficiency in Recovered COVID- 19 Patients', 'orgStudyIdInfo': {'id': 'MAHA2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (Respiratory Training Group)', 'description': 'It will include 30 patients of both sexes, recovered from COVID-19 infection. In addition to medical drugs, they will receive respiratory training for 6 weeks.', 'interventionNames': ['Other: Respiratory Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B : (Aerobic Training Group)', 'description': 'It will include 30 patients of both sexes, recovered from COVID-19 infection. In addition to medical drugs, they will receive aerobic training for 6 weeks', 'interventionNames': ['Other: Aerobic training']}, {'type': 'NO_INTERVENTION', 'label': 'Group C : (control group)', 'description': 'It will include 20 patients of both sexes, recovered from COVID-19 infection on medical drugs only will receive no exercise as control group.'}], 'interventions': [{'name': 'Respiratory Training', 'type': 'OTHER', 'description': 'Respiratory training in form of :\n\nDiaphragmatic breathing,Segmental breathing, Incentive spirometer:', 'armGroupLabels': ['Group A (Respiratory Training Group)']}, {'name': 'Aerobic training', 'type': 'OTHER', 'description': "aerobic exercises are customized according to the patient's underlying disease and residual dysfunction. These exercises will include walking on treadmill. After an initial, 5-minute warm-up phase performed on the treadmill at a low load, each endurance training session lasted 30 minutes and ended with 5-minute recovery and relaxation phase. A total of 3-5 sessions are carried out per week. Patients who are prone to fatigue should perform intermittent exercises", 'armGroupLabels': ['Group B : (Aerobic Training Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Police hospital-Nasr city', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Heba Ahmed Ali Abdeen', 'investigatorAffiliation': 'Cairo University'}}}}