Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-02 @ 6:46 AM
Study NCT ID:
NCT02459132
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2015-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Intensity Aerobic Interval Training in Testicular Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}, {'id': 'D001146', 'term': 'Arrhythmia, Sinus'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-20', 'studyFirstSubmitDate': '2015-05-21', 'studyFirstSubmitQcDate': '2015-05-29', 'lastUpdatePostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': 'Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing', 'description': 'Short form 36'}, {'measure': 'Depression', 'timeFrame': 'Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing', 'description': 'Centre for epidemiologic studies depression scale'}, {'measure': 'Fatigue', 'timeFrame': 'Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing', 'description': 'Functional Assessment of Cancer Therapy - Fatigue'}, {'measure': 'Sleep Quality', 'timeFrame': 'Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing', 'description': 'Global Pittsburg Sleep Quality Index'}, {'measure': 'Anxiety', 'timeFrame': 'Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing', 'description': 'Spielberger State Anxiety Scale'}, {'measure': 'Stress', 'timeFrame': 'Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing', 'description': 'Perceived Stress Scale'}, {'measure': 'Self-Esteem', 'timeFrame': 'Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing', 'description': 'Rosenberg Self-Esteem Scale'}], 'primaryOutcomes': [{'measure': 'Peak aerobic capacity (relative VO2peak)', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'ml O2/kg/min'}], 'secondaryOutcomes': [{'measure': 'Peak aerobic capacity (absolute VO2peak)', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'L/min'}, {'measure': 'Postexercise 1-minute heart rate recovery', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'change in beats/min'}, {'measure': 'Heart rate', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'beats/min'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'mmHg'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'mmHg'}, {'measure': 'Respiratory sinus arrhythmia', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'beats/min'}, {'measure': 'Average carotid intima-media thickness', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'mm'}, {'measure': 'Maximal carotid intima-media thickness', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'mm'}, {'measure': 'Carotid distensibility', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': '10-3/kPa'}, {'measure': 'Carotid diameter', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'mm'}, {'measure': 'Brachial flow-mediated dilation', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'percent dilation'}, {'measure': 'Brachial diameter', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'mm'}, {'measure': 'Velocity time integral', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'cm'}, {'measure': 'Shear stress during reactive hyperemia', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'dynes/cm2'}, {'measure': 'Carotid-femoral pulse wave velocity', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'm/s'}, {'measure': 'Femoral-toe pulse wave velocity', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'm/s'}, {'measure': 'Fibrinogen', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'g/L'}, {'measure': 'High-sensitivity C-reactive protein', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'mg/L'}, {'measure': 'Total cholesterol', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'mmol/L'}, {'measure': 'High-density lipoprotein', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'mmol/L'}, {'measure': 'Low-density lipoprotein', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'mmol/L'}, {'measure': 'Total cholesterol : high-density lipoprotein ratio', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'ratio'}, {'measure': 'Triglycerides', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'mmol/L'}, {'measure': 'Fasting glucose', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'mmol/L'}, {'measure': 'Testosterone', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'nmol/L'}, {'measure': 'Framingham Risk Score', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': '10 year CVD risk %'}, {'measure': 'Vascular age', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'years'}, {'measure': 'Modifiable CVD Risk Factor Score', 'timeFrame': 'Baseline and within 7 days of completing the 12-week intervention', 'description': 'Number (max 24)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High-intensity interval training', 'VO2peak', 'Brachial flow-mediated dilation', 'Carotid-femoral pulse wave velocity', 'Carotid intima-media thickness', 'Carotid distensibility', 'Respiratory sinus arrhythmia'], 'conditions': ['Cardiovascular Diseases', 'Testicular Neoplasms']}, 'referencesModule': {'references': [{'pmid': '28708930', 'type': 'DERIVED', 'citation': 'Adams SC, DeLorey DS, Davenport MH, Stickland MK, Fairey AS, North S, Szczotka A, Courneya KS. Effects of high-intensity aerobic interval training on cardiovascular disease risk in testicular cancer survivors: A phase 2 randomized controlled trial. Cancer. 2017 Oct 15;123(20):4057-4065. doi: 10.1002/cncr.30859. Epub 2017 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of a supervised 12-week high-intensity aerobic interval exercise program (versus a self-directed exercise usual care group) on traditional and novel cardiovascular disease risk factors and surrogate markers of cardiovascular- and overall-mortality in a population-based sample of testicular cancer survivors.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed history of testicular cancer\n\nExclusion Criteria:\n\n* Not sufficiently ambulatory to complete the first two stages of the aerobic exercise test.\n* Have a psychiatric condition which impairs their ability to perform the required volume and intensity of exercise.\n* Have any uncontrolled cardiovascular condition (i.e. heart disease, hypertension, diabetes, arrhythmia).\n* Report performing any weekly vigorous intensity aerobic exercise in the past month.'}, 'identificationModule': {'nctId': 'NCT02459132', 'acronym': 'HIITTS', 'briefTitle': 'High-Intensity Aerobic Interval Training in Testicular Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'A Phase II Randomized Trial of High-Intensity Aerobic Interval Training and Surrogate Markers of Cardiovascular Disease in a Population-based Sample of Testicular Cancer Survivors', 'orgStudyIdInfo': {'id': 'HREBA.CC-14-0183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Group', 'description': 'Subjects in the exercise group will attend supervised exercise sessions three times a week, for 12 weeks. The exercise intervention will consist of uphill walking or jogging on a treadmill between 50% and 95% of VO2peak for 35 minutes (including a 5-minute warm up and cool down). The participants will complete four, 4-minute, high-intensity intervals at 85-95% of VO2peak. The work period intervals will be interspersed with three, 3-minute periods of active recovery at an intensity below that of their ventilatory threshold.', 'interventionNames': ['Behavioral: High-intensity aerobic interval exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'The usual care group will not receive an intervention, and they will be asked to maintain baseline physical activity levels throughout the observation period.'}], 'interventions': [{'name': 'High-intensity aerobic interval exercise', 'type': 'BEHAVIORAL', 'description': 'See arm/group description', 'armGroupLabels': ['Exercise Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kerry S Courneya, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}