Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-08 @ 9:20 AM
Study NCT ID:
NCT03730818
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2018-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Water-based Versus Land-based Exercise for Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is an assessor-blind study. Physiotherapist in charge of performing the baseline and post-intervention assessment will be blinded to participants allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-27', 'studyFirstSubmitDate': '2018-11-01', 'studyFirstSubmitQcDate': '2018-11-02', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Cancer-related Fatigue', 'timeFrame': 'Cancer-related fatigue from baseline throughout the study period (24 weeks)', 'description': 'Cancer-related fatigue as measure with the specific subscale found in the EORTC QLQ C30 questionnaire specifically designed for a cancer population'}], 'secondaryOutcomes': [{'measure': 'Change in Exercise Functional Capacity', 'timeFrame': 'Exercise functional capacity from baseline throughout the study period (24 weeks)', 'description': '6 Minute Walk Test performed accordingly to international guidelines'}, {'measure': 'Change in Physical Activity levels', 'timeFrame': 'Physical activity levels from baseline throughout the study period (24 weeks)', 'description': 'Physical Activity in METS-hour/week and minutes/week assessed with a triaxial accelerometer (Actigraph wgt3x-bt)'}, {'measure': 'Change in Upper Body Strength', 'timeFrame': 'Upper body strength from baseline throughout the study period (24 weeks)', 'description': 'Upper body muscle strength measured with a hand-held dynamometer and a handgrip test'}, {'measure': 'Change in Lower Body Strength', 'timeFrame': 'Lower body strength from baseline throughout the study period (24 weeks)', 'description': 'Lower body muscle strength measured with a hand-held dynamometer (leg extension) and the sit-to-stand test'}, {'measure': 'Change in Health-Related Quality of Life', 'timeFrame': 'Health-related quality of life from baseline throughout the study period (24 weeks)', 'description': 'HRQoL measured with the EORTC QLQ C30 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise Therapy', 'Aquatic Therapy', 'Health-Related Quality of Life', 'Cancer-related Fatigue', 'Exercise Tolerance', 'Physical Activity'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Physical activity and exercise have demonstrated to be an integral part of the cancer-continuum care. Despite strong evidence suggesting that both endurance and strength training should be encourage in cancer patients, there is still controversy regarding exercise dosage, frequency, volume and optimal environment of delivery. In this randomised controlled trial we aim to compare water-based versus land-based exercise in breast cancer survivors to decrease cancer-related fatigue (CRF), improve Health-Related Quality of Life (HRQoL), exercise tolerance, muscle strength and physical activity levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast Cancer patients post cancer treatment (at least for 6 months)\n* Cancer-free at the time of recruitment\n* Signed informed consent\n* Living in the metropolitan area of Barcelona\n\nExclusion Criteria:\n\n* Fear of water\n* Receiving cancer therapy at the time of recruitment\n* Not willing to participate/Refuse to sign informed consent\n* Physical of cognitive impairments precluding the patient to perform the exercises'}, 'identificationModule': {'nctId': 'NCT03730818', 'briefTitle': 'Water-based Versus Land-based Exercise for Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Pompeu Fabra'}, 'officialTitle': 'Effects of Water-based Versus Land-based Exercise on Cancer-related Fatigue and Functional Capacity in Breast Cancer Survivors', 'orgStudyIdInfo': {'id': 'AQUAFIT-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Water-based Exercise Group', 'description': 'The Water-based Exercise Group will compromise participants attending a 2 weekly exercise intervention each session lasting 1 hour for 12 weeks.\n\nEach session will consist of:\n\n* 10 minutes of warm-up: general mobilisation, walking, active stretching\n* 40 minutes of global training: 20 minutes of endurance exercise and 20 minutes of resistance exercises targeting large main muscle groups involved in daily life activities (squats, lateral hip abduction, row, etc.) using body weight and elastic bands\n* 10 minutes of cooling down: stretching, breathing exercises and relaxation Intensity will be monitored with the modified Borg Scale to maintain a 5 - 6 level of exertion during the first 5 weeks and progressively increase to a 6 - 7 level for the following weeks.', 'interventionNames': ['Other: Water-based Exercise Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Land-based Exercise Group', 'description': 'The land-based exercise group will attend as well 2 weekly sessions lasting 1 hour each for 12 weeks.\n\nEach session will consist of the same structure as the Water-based Exercise Group including:\n\n* 10 minutes warm up\n* 40 minutes of global training (20 minutes of endurance exercise and 20 minutes of resistance training)\n* 10 minutes cool down. The exercises will be adapted from the water-based exercise group to match the requirements on the water-based exercise group. Intensity will be monitored with the Perceived Rate of Exertion Scale (modified Borg Scale, Borg 1982) to maintain a 5 - 6 level of exertion during the first 5 weeks and progressively increase to a 6 - 7 level for the following weeks.', 'interventionNames': ['Other: Land-based Exercise Group']}], 'interventions': [{'name': 'Water-based Exercise Group', 'type': 'OTHER', 'description': 'The intervention consist will of a water-based exercise protocol', 'armGroupLabels': ['Water-based Exercise Group']}, {'name': 'Land-based Exercise Group', 'type': 'OTHER', 'description': 'The intervention will consist of a land-based exercise protocol', 'armGroupLabels': ['Land-based Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Centre Claror - Fundació Marítim', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Pompeu Fabra', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital del Mar', 'class': 'OTHER'}, {'name': 'Centre Esportiu Claror Marítim', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Raquel Sebio', 'investigatorAffiliation': 'Universitat Pompeu Fabra'}}}}