Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 4:15 PM
Study NCT ID:
NCT04656457
Status:
UNKNOWN
Last Update Posted:
2021-01-28
First Post:
2020-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESISTANCE VERSUS AEROBIC EXERCISES ON Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue assessment scale', 'timeFrame': 'The evaluation will be conducted during before the cycles', 'description': 'The Fatigue Assessment Scale (FAS) is quick and easy to complete for patients, and not time consuming. It is also helpful for physicians and other health care workers in the follow-up of their patients. The FAS has proven to be a valid questionnaire to assess fatigue in cancer patients, but also in many other patients with chronic diseases'}, {'measure': 'Fatigue assessment scale', 'timeFrame': 'The evaluation will be conducted during one and half month', 'description': 'The Fatigue Assessment Scale (FAS) is quick and easy to complete for patients, and not time consuming. It is also helpful for physicians and other health care workers in the follow-up of their patients. The FAS has proven to be a valid questionnaire to assess fatigue in cancer patients, but also in many other patients with chronic diseases'}, {'measure': 'Fatigue assessment scale', 'timeFrame': 'The evaluation will be conducted three months later', 'description': 'The Fatigue Assessment Scale (FAS) is quick and easy to complete for patients, and not time consuming. It is also helpful for physicians and other health care workers in the follow-up of their patients. The FAS has proven to be a valid questionnaire to assess fatigue in cancer patients, but also in many other patients with chronic diseases'}, {'measure': 'Hemoglobin level test for fatigue assessment', 'timeFrame': 'he evaluation will be conducted before the cycles', 'description': 'Hemoglobin levels are measured by a blood test. Hemoglobin, or Hb, is usually expressed in grams per deciliter (g/dL) of blood. A low level of hemoglobin in the blood relates directly to a low level of oxygen'}, {'measure': 'Hemoglobin level test for fatigue assessment', 'timeFrame': 'he evaluation will be conducted during one and half month', 'description': 'Hemoglobin levels are measured by a blood test. Hemoglobin, or Hb, is usually expressed in grams per deciliter (g/dL) of blood. A low level of hemoglobin in the blood relates directly to a low level of oxygen'}, {'measure': 'Hemoglobin level test for fatigue assessment', 'timeFrame': 'he evaluation will be conducted three months later', 'description': 'Hemoglobin levels are measured by a blood test. Hemoglobin, or Hb, is usually expressed in grams per deciliter (g/dL) of blood. A low level of hemoglobin in the blood relates directly to a low level of oxygen'}, {'measure': 'White blood cells count test for immunity assessment', 'timeFrame': 'he evaluation will be conducted before the cycles', 'description': 'White blood cells (also called leukocytes and abbreviated as WBCs) are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from multipotent cells in the bone marrow known as hematopoietic stem cells. Leukocytes are found throughout the body, including the blood and lymphatic system'}, {'measure': 'White blood cells count test for immunity assessment', 'timeFrame': 'he evaluation will be conducted during one and half month', 'description': 'White blood cells (also called leukocytes and abbreviated as WBCs) are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from multipotent cells in the bone marrow known as hematopoietic stem cells. Leukocytes are found throughout the body, including the blood and lymphatic system'}, {'measure': 'White blood cells count test for immunity assessment', 'timeFrame': 'he evaluation will be conducted three months later', 'description': 'White blood cells (also called leukocytes and abbreviated as WBCs) are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from multipotent cells in the bone marrow known as hematopoietic stem cells. Leukocytes are found throughout the body, including the blood and lymphatic system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate which is more effective resistance or aerobic exercises on cancer related fatigue and immunity in breast cancer patients undergoing adjuvant chemotherapy.', 'detailedDescription': 'The problem of cancer related fatigue and decreased immunity, as a result of treatment with adjuvant chemotherapy in breast cancer patients is not well known.\n\nFatigue and decreased immunity have a negative impact on work, social relationships, mood, and daily activities and cause significant impairment in overall quality of life, Furthermore the need of this study is developed from the lack of information in the published studies about the effect of the treatment with chemotherapy among breast cancer patients on inducing fatigue and decreasing immunity and the effect of resistance and aerobic exercises on improving these changes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nThe subject selection will be according to the following criteria:\n\n1. Age range from 30-60 years.\n2. Females post mastectomy only will participate in the study.\n3. All patients undergoing adjuvant chemotherapy and have cancer related fatigue and decreased immunity.\n4. All patients enrolled to the study will have their informed consent.\n\nExclusion Criteria:\n\n* The potential participants will be excluded if they meet one of the following criteria:\n\n 1. Age more than 60 years or less than 30 years.\n 2. Another concurrent malignant disease.\n 3. Subjects suffering from any condition for which resistance or aerobic exercises contraindicated as metastasis, sever osteoporosis and cardiac diseases.'}, 'identificationModule': {'nctId': 'NCT04656457', 'briefTitle': 'RESISTANCE VERSUS AEROBIC EXERCISES ON Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Resistance Versus Aerobic Exercises On Cancer Related Fatigue And Immunity In Breast Cancer Patients Undergoing Adjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'P.T.REC/012/002968'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'resistance exercises', 'description': 'Resistance exercises will be involved in this technique are for upper and lower limb (Exercise program including shoulder flexion, abduction and horizontal adduction, elbow extension and flexion, calf raise, leg extension and squatting) three times daily and five times per week. The 1 repetition maximum (1RM) is measured at baseline and following the intervention. Initially, participants will do two circuits using 50% of their 1RM and repeat them 10 times for the first and second weeks, progressing to two circuits, using 60% of their 1RM and repeat 10 times for the third and fourth weeks. In fifth and sixth weeks, participants will do three circuits using 60% of their 1RM and repeat 10 times. In the last 6 weeks, patients will do three circuits using 70% of their 1RM and repeat 10 times. Time of exercise equal time of rest', 'interventionNames': ['Other: resisted exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'aerobic exercise', 'description': 'Aerobic training (AT) program of submaximal intensity will include a 45-minute session five times per week under the supervision of the researcher. Aerobic exercise will consist of three phases: warm-up, training and cool down. At the beginning of exercise session, subjects will have a ten-minute warm-up. The warm up protocol will be slowly running on treadmill. Then, the warm-up phase will be followed by the training phase. At baseline, the training phase will be commenced with two 30- minute running on treadmill at 50% of their maximal heart rate (MHR) in the first week and increased to 70% MHR by the final week of training. By the end of exercise session, subjects will have a five-minute cool down. The cool down protocol will be slowly running on treadmill. The vital measures such as HR and blood pressure was monitored before patient left the department (Dimeo et al.,2016), maximum heart rate will be calculated using the formula: (HR Max =220- age)', 'interventionNames': ['Device: Treadmill']}], 'interventions': [{'name': 'Treadmill', 'type': 'DEVICE', 'description': 'Treadmill is not used to harness power, but as exercise machines for running or walking in one place. Rather than the user powering the mill, the machine provides a moving platform with a wide conveyor belt driven by an electric motor or a flywheel. The belt moves to the rear, requiring the user to walk or run at a speed matching that of the belt. The rate at which the belt moves is the rate of walking or running. Thus, the speed of running may be controlled and measured', 'armGroupLabels': ['aerobic exercise']}, {'name': 'resisted exercises', 'type': 'OTHER', 'description': 'Resistance exercises will be involved in this technique are for upper and lower limb (Exercise program including shoulder flexion, abduction and horizontal adduction, elbow extension and flexion, calf raise, leg extension and squatting)', 'armGroupLabels': ['resistance exercises']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Lamiaa S Saleh, Master', 'role': 'CONTACT', 'email': 'Lamiaa.said@pua.edu.eg', 'phone': '01007215433'}], 'facility': 'Medical research institute', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Lamiaa sa tolba, ASS.lecturer', 'role': 'CONTACT', 'email': 'lamiaa.said@pua.edu.eg', 'phone': '01007215433'}, {'name': 'Amal mo abdel baky, Professor', 'role': 'CONTACT', 'email': 'amalabaky@yahoo.com', 'phone': '01124663339'}], 'overallOfficials': [{'name': 'Amal mo abdel baky, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of physical therapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSISSTANT LECTURER', 'investigatorFullName': 'Lamiaa said tolba saleh', 'investigatorAffiliation': 'Cairo University'}}}}