Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT03212560
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2017-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Capacity and Physical Activity Levels in Newly Diagnosed Hematologic Malignant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'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'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2017-07-03', 'studyFirstSubmitQcDate': '2017-07-07', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional exercise capacity', 'timeFrame': 'first day', 'description': 'Evaluated using 6-minute walking test'}, {'measure': 'Physical activity', 'timeFrame': 'first day', 'description': 'Evaluated using a metabolic holter'}, {'measure': 'General quality of life', 'timeFrame': 'second day', 'description': 'Evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)'}, {'measure': 'Disease-specific quality of life', 'timeFrame': 'second day', 'description': 'The Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)'}, {'measure': 'FACT', 'timeFrame': 'second day', 'description': 'The Functional Assessment of Cancer Therapy-Anemia (FACT-An)'}], 'secondaryOutcomes': [{'measure': 'Pulmonary functions', 'timeFrame': 'first day', 'description': 'Evaluated using spirometer'}, {'measure': 'Muscle strength', 'timeFrame': 'second day', 'description': 'Evaluated using hand-held dynamometer for peripheral muscles (shoulder abduction, shoulder flexion, knee extension, hand grip strength)'}, {'measure': 'Respiratory muscle strength', 'timeFrame': 'second day', 'description': 'Evaluated using mouth pressure device'}, {'measure': 'Respiratory muscle endurance', 'timeFrame': 'second day', 'description': 'Evaluated using respiratory muscle trainer (POWERbreathe)'}, {'measure': 'Fatigue', 'timeFrame': 'second day', 'description': 'Evaluated using Fatigue Severity Scale'}, {'measure': 'Dyspnea', 'timeFrame': 'first day', 'description': 'Evaluated using Modified Medical Research Council Dyspnea scale (MMRC)'}, {'measure': 'Activity dyspnea', 'timeFrame': 'first day', 'description': 'Evaluated using Modified Borg Scale'}, {'measure': 'Anxiety', 'timeFrame': 'second day', 'description': 'Evaluated using Hospital Anxiety and Depression Scale'}, {'measure': 'Depression', 'timeFrame': 'second day', 'description': 'Montgomery-Åsberg Depression Rating Scale'}, {'measure': 'Hospital depression', 'timeFrame': 'second day', 'description': 'Evaluated using Hospital Anxiety and Depression Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exercise capacity', 'Physical activity', 'Quality of life', 'Pulmonary functions', 'Muscle strength', 'Respiratory muscle strength', 'Respiratory muscle endurance', 'Dyspnea', 'Anxiety', 'Fatigue'], 'conditions': ['Hematologic Malignancies']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/?term=.+Paul+KL.+Rehabilitation+and+exercise+considerations+in+hematologic+malignancies.+Am+J+Phys+Med+Rehabil.+2011%3B+90+(5)%3A+88-94.', 'label': 'Related Info'}, {'url': 'http://www.google.com.tr/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0ahUKEwjd7Kmf993UAhUrKsAKHZ6nBBMQFgghMAA&url=http%3A%2F%2Fwww.leukaemia.org.au%2Fdownload.cfm%3Fdownloadfile%3DB56963F0-EA25-11E4-9CF8005056B60026%26typename%3DdmFile%26fieldname%3Dfilename%26filename%3DLLM-WEB6.pdf&usg=AFQjCNHOUG3dtwum5wS8AZxADxPP9X9IPQ', 'label': 'Related Info'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/?term=Cleeland+CS.+Cancer-related+fatigue%3A+new+directions+for+research.+Cancer.+2001%3B+92+(6+suppl)%3A+1657-1661.', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Hematologic malignancies are neoplasms that affect the blood, bone marrow, and lymph nodes. Hematological malignancies are the most common forms of leukemia, lymphoma, and myeloma, with numerous subtypes. The general symptoms of leukemia are fatigue, increased susceptibility to infection, bleeding, and the formation of bruises easily. Typical lymphoma symptoms are night sweats and involuntary weight loss, recurrent fever, fatigue, and itching. Myeloma patients often have bone pain, fatigue, anemia, hypercalcemia or infection symptoms.\n\nAdverse effects of hematologic malignancies and treatments cause abnormality in physical function and quality of life. Treatments such as chemotherapy, radiotherapy and hematopoietic stem cell transplantation, which may have side effects on the body systems are used in early or late period. The most common side effect due to chemotherapy is fatigue. Vomiting, weight loss, anemia, depression, decreased aerobic capacity, loss of muscle strength, decreased physical functioning and deterioration in the quality of life are indirect side effects seen in patients.\n\nIn the literature, side effects of hematological malignancies have been investigated after treatment in patients. However, no study investigated exercise capacity, quality of life, physical activity level and pulmonary functions on newly diagnosed hematologic malignant patients. Therefore, the investigators aimed to compare aforementioned outcomes in newly diagnosed hematologic malignant patients and healthy controls.', 'detailedDescription': 'According to sample size calculation 30 newly diagnosed hematologic malignant patients and 30 healthy individuals will be included. Before treatment submaximal exercise capacity, physical activity, quality of life, pulmonary functions, respiratory and peripheral muscle strength, respiratory muscle endurance, dyspnea and fatigue perception, anxiety and depression will be evaluated. Primary outcome measurements are exercise capacity, physical activity, quality of life, secondary outcomes are respiratory and peripheral muscle strength, respiratory muscle endurance, pulmonary functions, dyspnea and fatigue perception, anxiety and depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients and healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed hematological malignant patients\n* 18-65 years of age\n* under standard medications.\n\nExclusion Criteria:\n\n* having cognitive disorder,\n* orthopedic or neurological disease with a potential to affect functional capacity,\n* comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute infections or pneumonia,\n* problems which may prevent evaluating such as visual problems and mucositis\n* having metastasis to any region (bone etc.)\n* having acute hemorrhage in the intracranial and / or lung and other areas\n* having any contraindication to exercise training'}, 'identificationModule': {'nctId': 'NCT03212560', 'briefTitle': 'Exercise Capacity and Physical Activity Levels in Newly Diagnosed Hematologic Malignant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Exercise Capacity, Physical Activity Level and Quality of Life in Newly Diagnosed Hematologic Malignant Patients', 'orgStudyIdInfo': {'id': 'Gazi University1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Newly diagnosed individuals', 'description': 'Newly diagnosed hematologic malignant patients included in the study. Inclusion and exclusion criteria were considered.'}, {'label': 'Healthy individuals', 'description': 'Those without chronic disease were included in the study. Inclusion and exclusion criteria were considered.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yenimahalle', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation', 'geoPoint': {'lat': 40.22627, 'lon': 27.4238}}], 'overallOfficials': [{'name': 'Zeliha Çelik, Pt', 'role': 'STUDY_CHAIR', 'affiliation': 'Research assistant'}, {'name': 'Meral Boşnak Güçlü, Pt, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate professor'}, {'name': 'Zübeyde Nur Özkurt, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Meral Boşnak Güçlü', 'investigatorAffiliation': 'Gazi University'}}}}