Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-02 @ 2:25 AM
Study NCT ID:
NCT02734394
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2016-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UW WELL-FIT Exercise Program for Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2016-02-09', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Exercise Test', 'timeFrame': '24 sessions (12 weeks)', 'description': 'Pre and post maximum workload using an electronic cycle ergometer in Watts'}, {'measure': 'Upper and Lower Limb Strength', 'timeFrame': '24 sessions (12 weeks)', 'description': 'pre and post strength in upper and lower limb muscles using a linear differential variable transducer (LVDT) measured in Newton.meters'}, {'measure': 'Body Mass Index', 'timeFrame': '24 sessions (12 weeks)', 'description': 'Pre and post body mass index (kg/m2)'}, {'measure': 'Percent Body Fat', 'timeFrame': '24 sessions (12 weeks)', 'description': 'Pre and Post percent body fat (units: %)'}], 'secondaryOutcomes': [{'measure': 'Glucose', 'timeFrame': '24 sessions (12 weeks)', 'description': 'measurement of blood glucose in mM'}, {'measure': 'Lipids', 'timeFrame': '24 sessions (12 weeks)', 'description': 'measurement of total cholesterol, low density lipoprotein,high density lipoprotein ( millimole per liter (mM/L)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['exercise', 'body composition', 'metabolism', 'nutrition'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to help to manage the many cancer treatment side effects through cardiovascular and resistance exercise, and education with the goal of using program outcomes to contribute to current research.', 'detailedDescription': 'This study is a single group pre-test post-test design.There are 4 optional measures that will be presented to participants from which they can choose to participate or not. These are presented with check boxes in the consent form. After completion of the University of Waterloo (UW) WELL-FIT program, participants will be given an option to continue with an exercise program; they will be offered the Graduate Program. Following consent of Graduate Program, repeated measures would be taken annually. At the time of consent, they will have the option to have their data used in research. At any point in their involvement of the exercise based programs, they can indicate "they no longer want to participate in the program or the data collection". Their medical care or participation in the UW WELL-FIT program will not be affected.\n\nProcedures\n\n1. UW WELL-FIT advertisement for Grand River Regional Cancer Centre\n2. UW WELL-FIT brochure\n3. Referral Form\n4. Participants initial consultation and assessment\n5. Obtain consent for UW WELL-FIT\n6. Obtain Participant Information\n7. Completion of FACIT-F survey\n8. Metabolism \\& Body Composition - Information sheet for optional measures\n9. Physical Activity Survey- Godin Questionnaire\n10. Provide 3-Day food diary and Nutritional Assessment\n11. Fitness assessment, exercise programming and data entry:\n\n 1. Submaximal cardiovascular cycle ergometer or treadmill graded exercise test\n 2. Muscular strength using force transducer\n 3. Body composition:\n\n * Height, weight and waist girth\n * Bioelectrical Impedance Analysis (BIA)\n * Dual Energy X-ray Absorption (Optional)\n 4. Range of motion using a goniometer\n 5. Blood sampling (Optional)\n 6. Design Individualized exercise program\n12. UW WELL-FIT - Commencement of participant in 12 week exercise program (2 x 60 minute classes)\n13. Post assessment (repeated pre-test assessments)\n14. Pre and post data are entered into database\n15. Summary and Feedback Report\n16. Graduate Program: participant selects to attend UW WELL-FIT Graduate Program\n17. Participants have annual reassessments in the Graduate Program'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previously diagnosed with cancer and will currently be receiving some form of treatment (chemotherapy, radiation therapy or hormonal therapy)\n\nExclusion Criteria:\n\n* Physical / health factors that prohibit exercise or lack of medical clearance from physician'}, 'identificationModule': {'nctId': 'NCT02734394', 'acronym': 'WELL-FIT', 'briefTitle': 'UW WELL-FIT Exercise Program for Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Waterloo'}, 'officialTitle': 'UW WELL-FIT Exercise Program for Cancer Patients', 'orgStudyIdInfo': {'id': 'ORE18987-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiovascular and strength training exercise', 'description': '24 sessions (\\~12 weeks) exercise', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Cardiovascular and resistance exercise training', 'armGroupLabels': ['Cardiovascular and strength training exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Waterloo', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Caryl Russell, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Waterloo'}, {'name': 'Michael Sharratt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Waterloo'}, {'name': 'Marina Mourtzakis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Waterloo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Waterloo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research and Operations Manager', 'investigatorFullName': 'Julia Fraser', 'investigatorAffiliation': 'University of Waterloo'}}}}