Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT01705951
Status:
UNKNOWN
Last Update Posted:
2012-10-12
First Post:
2012-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], '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': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-11', 'studyFirstSubmitDate': '2012-10-05', 'studyFirstSubmitQcDate': '2012-10-11', 'lastUpdatePostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Endothelial Progenitor Cells (EPC) count', 'timeFrame': '12 weeks', 'description': 'EPC count is measured using a novel flow cytometry protocol.'}, {'measure': 'Insulin sensitivity by Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)', 'timeFrame': '12 Weeks'}, {'measure': 'Plasma biomarkers inflammation/oxidative stress (oxidized low density lipoprotein (OxLDL), CRP)', 'timeFrame': '12 Weeks'}, {'measure': 'Body Composition', 'timeFrame': '12 Weeks', 'description': 'Lean mass and fat mass are measured by the Dual Energy X-ray Absorptiometry (DEXA) Scan.'}, {'measure': 'Muscle Strength', 'timeFrame': '12 Weeks', 'description': 'Muscle strength is evaluated by a one-Repetition Maximum (1RM) protocol and VO2 peak is assessed by a maximal incremental cardiopulmonary exercise test.'}], 'primaryOutcomes': [{'measure': 'Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Smoking cessation percentage', 'timeFrame': '12 weeks'}, {'measure': 'Arterial stiffness (including PWV and AIx)', 'timeFrame': '12 weeks'}, {'measure': 'Number of cigarettes smoked', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking', 'Insulin resistance', 'Metabolic Syndrome', 'Endothelial Function', 'Smoking Cessation', 'Resistance Training', 'Nicotine Replacement', 'Exercise', 'Cardiovascular Disease', 'Arterial Stiffness', 'Body Composition'], 'conditions': ['Smoking', 'Cardiovascular Disease Risk']}, 'descriptionModule': {'briefSummary': 'This project is prompted by the urgent public health need to identify novel strategies to prevent and treat tobacco-related cardiovascular disease (CVD) and by compelling pilot data that suggests cessation of smoking results in rapid amelioration of endothelial function. The higher prevalence of CVD and metabolic syndrome in smokers have become major health care concerns. Therefore, finding optimal intervention strategies to combat these growing epidemics is imperative. We are investigating the efficacy of resistance training to ameliorate endothelial dysfunction, oxidative stress, inflammation, and insulin resistance in four groups: presence or absence of resistance training with or without cessation treatment + nicotine replacement.\n\nThe investigators hypothesize that resistance training will improve cardiovascular function in smokers; however, the responses will be better in those who also stop smoking. In addition, resistance training will decrease smoking, however, the effects of counseling and nicotine replacement alone or counseling and nicotine replacement in conjunction with resistance training will be better than resistance training alone.', 'detailedDescription': "The investigators are conducting a 12-week randomized-controlled trial of 100 young adult smokers.\n\nAt week 0, participants attend three outpatient visits at baseline. Each participant is randomized to one of four groups: Resistance Training(RT)/Nicotine Replacement Therapy (NRT), RT/No NRT, No RT/NRT, and No RT/No NRT. Those receiving RT work with a certified personal trainer 3 times per week for 12 weeks at 60 minutes each session. Those receiving NRT use the nicotine patch daily for 12 weeks and call the California Smoker's Helpline for smoking cessation counseling. Those in the control group do not receive any intervention and maintain their current lifestyle and habits.\n\nAt week 13, participants return for three post-intervention assessments.\n\nAt week 26, survey data is collected to assess changes in lifestyle habits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Young Adults (18-35 yrs.)\n* Male and female smokers\n* Smokers (smoked at least one cigarette a day for 15 or more days in the last month and has smoked 100 cigarettes in life)\n* 1-3 years experience consistently exercising/training at ≤2 days/wk of RT and ≤1 day/wk of aerobic exercise\n* Capable of providing informed consent\n* UCLA students/staff and Non UCLA student/staff\n* Participant in good health as determined by baseline visit\n\nExclusion Criteria:\n\n* Documented CAD\n* Has had cardiac surgery\n* Currently in weight loss or exercise program in the 6 months prior to participation.\n* Use of medications that influence CV function or preclude the ability to train\n* Syndromes or prescribed medications that may influence CVD, body composition, or insulin action (e.g. prednisone, Ritalin, Adderall, GH)\n* Unable to exercise\n* Diagnosed with syndromes or diseases that may influence body composition and CV risk (e.g. Cushing syndrome).\n* Known heart arrhythmia and/or abnormalities found in electrocardiogram (ECG) reading that would prevent someone from performing the exercise intervention. If the subject demonstrates abnormal ECG during their pre-intervention visit (or any follow-up visit) the subject's ECG will be reviewed (for approval) by a cardiologist to continue in the study.\n* Pregnant\n* Use of hormonal contraceptives\n* Currently in a smoking cessation program including use of NRT within the month of participation"}, 'identificationModule': {'nctId': 'NCT01705951', 'acronym': 'START', 'briefTitle': 'Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk', 'orgStudyIdInfo': {'id': '19KT-0028'}, 'secondaryIdInfos': [{'id': 'UL1TR000124', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR000124', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Resistance Training/Nicotine Replacement', 'interventionNames': ['Other: Resistance Training (RT)', 'Biological: Nicotine Replacement Therapy (NRT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Resistance Training only', 'interventionNames': ['Other: Resistance Training (RT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Nicotine Replacement Therapy only', 'interventionNames': ['Biological: Nicotine Replacement Therapy (NRT)']}, {'type': 'NO_INTERVENTION', 'label': 'Group 4: Control; no RT and no NRT'}], 'interventions': [{'name': 'Resistance Training (RT)', 'type': 'OTHER', 'description': 'Resistance Training program 3x/week at 60 minutes per session for 12 weeks.', 'armGroupLabels': ['Group 1: Resistance Training/Nicotine Replacement', 'Group 2: Resistance Training only']}, {'name': 'Nicotine Replacement Therapy (NRT)', 'type': 'BIOLOGICAL', 'otherNames': ['GlaxoSmithKline Nicoderm CQ patch'], 'description': "Nicotine patch for 12 weeks (21mg, 14mg, 7mg.) and referral to California Smoker's Helpline for 6 sessions of smoking cessation counseling.", 'armGroupLabels': ['Group 1: Resistance Training/Nicotine Replacement', 'Group 3: Nicotine Replacement Therapy only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Exercise and Metabolic Disease Laboratory', 'role': 'CONTACT', 'email': 'info@uclaemdr.com'}], 'overallOfficials': [{'name': 'Christian K Roberts, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor', 'investigatorFullName': 'Christian Roberts, PhD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}