Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT04259593
Status:
COMPLETED
Last Update Posted:
2020-02-06
First Post:
2020-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise for Elderly Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The eligibility rate', 'timeFrame': '6 months', 'description': 'the eligibility rate was assessed by the number of eligible patients divided by the total number of elements on the sampling frame.'}, {'measure': 'The recruitment rate', 'timeFrame': '6 months', 'description': 'the recruitment rate was assessed by the number of patients included in the study divided by the total number of eligible patients'}, {'measure': 'The exercise adherence rate', 'timeFrame': '4 months', 'description': 'The exercise adherence rate was assessed by the number of exercise sessions attended out of the 48 sessions scheduled for each patient'}, {'measure': 'The assessment rate', 'timeFrame': '6 months', 'description': 'The assessment rate was assessed by the number of patients who completed the T1 and T2 follow-up times over the total number who participated in the study'}, {'measure': 'Safety of the exercise training', 'timeFrame': '6 months', 'description': 'Safety was assessed by monitoring any serious adverse events that occured during the ET period.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise training, Complementary therapy'], 'conditions': ['Elderly Lymphoma Patients']}, 'referencesModule': {'references': [{'pmid': '24478323', 'type': 'BACKGROUND', 'citation': 'Streckmann F, Kneis S, Leifert JA, Baumann FT, Kleber M, Ihorst G, Herich L, Grussinger V, Gollhofer A, Bertz H. Exercise program improves therapy-related side-effects and quality of life in lymphoma patients undergoing therapy. Ann Oncol. 2014 Feb;25(2):493-9. doi: 10.1093/annonc/mdt568.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study was designed in a real-life setting to establish the feasibility, the safety and the activity of a supervised and combined Exercise Training (ET) program in adult and elderly lymphoma patients undergoing cancer-treatments.', 'detailedDescription': 'Eligible patients were assigned to the ET group. All the patients eligible for exercise but not partiticpating to the ET program because of logistical reasons, were considered as the control group. All clinical outcomes were assessed before exercise training (T0), 3 (T1) and 6-months (T2) after the beginning of the exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18-80 years old, histologically confirmed HL or NHL, patients in need of first or subsequent lines of systemic treatment and with a long-life expectancy\n\nExclusion Criteria:\n\n* Patients were excluded if they had less than 4 months of anti-cancer treatment to be delivered, severe orthopaedic, cardiac, pulmonary, or cognitive impairment, osteolytic lesions with the risk of fracture, cachexia or if they were ≥ 65 years and frail on the basis of comprehensive geriatric assessment'}, 'identificationModule': {'nctId': 'NCT04259593', 'briefTitle': 'Exercise for Elderly Lymphoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Exercise Training is a Feasible and Active Complementary Therapy in Adult and Elderly Patients Receiving Anti- Lymphoma Treatments', 'orgStudyIdInfo': {'id': '553'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Training Group', 'description': 'Exercise training group performed three weekly sessions for 16 weeks. This program consisted of moderate intensity aerobic, resistance, balance, and stretching exercises. The duration of every exercise session was 35 minutes during the first week and 65 minutes from the second week onward.', 'interventionNames': ['Other: exercise training']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group received usual lymphoma care'}], 'interventions': [{'name': 'exercise training', 'type': 'OTHER', 'armGroupLabels': ['Exercise Training Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00189', 'city': 'Rome', 'country': 'Italy', 'facility': "Sant'Andrea Hospital", 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Maria Christina Cox', 'role': 'STUDY_CHAIR', 'affiliation': "Sant'Andrea Hospital, Rome, Italy"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Mario Vetrano, MD', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}