Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-02-22 @ 12:43 PM
Study NCT ID:
NCT01951456
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2013-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Training as an Aid to Smoking Cessation Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D006262', 'term': 'Health'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-19', 'studyFirstSubmitDate': '2013-09-10', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking cessation', 'timeFrame': 'Change from baseline to 3 months', 'description': 'Salivary cotinine-verified 7-day Point Prevalence Abstinence (7-day PPA) from nicotine (cigarette smoking).'}], 'secondaryOutcomes': [{'measure': 'Cortisol', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Mood', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Cigarette cravings', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Abstinence self-efficacy', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Sleep', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Body composition', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Body weight', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Lung function', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Blood pressure', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Cholesterol profile', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Glycosylated hemoglobin', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Muscular strength', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Aerobic fitness', 'timeFrame': '3, 6, 12 months', 'description': 'Six-minute walk test'}, {'measure': 'Smoking cessation', 'timeFrame': 'Change from baseline to 6 months', 'description': 'Salivary cotinine-verified 7-day Point Prevalence Abstinence (7-day PPA) from nicotine (cigarette smoking).'}, {'measure': 'Smoking cessation', 'timeFrame': 'Change from baseline to 12 months', 'description': 'Salivary cotinine-verified 7-day Point Prevalence Abstinence (7-day PPA) from nicotine (cigarette smoking).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking cessation', 'resistance training'], 'conditions': ['Cigarette Smoking']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether resistance training can aid smoking cessation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18 or older, smoke five or more cigarettes a day for at least the past 12 months\n\nExclusion Criteria:\n\nParticipating in any type of exercise for \\>60 minutes/week over the past 3 months, current smokeless tobacco use, participation in an ongoing effort to quit smoking, current or planned pregnancy, any serious medical condition that would make exercise unsafe'}, 'identificationModule': {'nctId': 'NCT01951456', 'briefTitle': 'Resistance Training as an Aid to Smoking Cessation Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Teachers College, Columbia University'}, 'officialTitle': 'Resistance Training as an Aid to Smoking Cessation Treatment', 'orgStudyIdInfo': {'id': '1R01HL117345-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL117345-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance training', 'description': 'Participants will attend two, 45-60-minute progressive, moderate intensity resistance training sessions per week for 12 weeks. The program will maintain a format of a 5-minute warm-up, 35-50 minutes of resistance training and a 5-minute cool-down with flexibility and abdominal exercises.', 'interventionNames': ['Behavioral: Resistance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health and Wellness', 'description': 'Participants in this group will be required to attend the exact same number of sessions as those in the Resistance Training group. Each session will last approximately 45-60 minutes. Sessions will include a practical component/demonstration, an informational video, and a handout on a pertinent healthy lifestyle topic for adults.', 'interventionNames': ['Behavioral: Health and Wellness']}], 'interventions': [{'name': 'Resistance training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Resistance training']}, {'name': 'Health and Wellness', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Health and Wellness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10027', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Teachers College, Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teachers College, Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brown University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}