Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT00146133
Status:
COMPLETED
Last Update Posted:
2006-05-03
First Post:
2005-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Weight Loss and Exercise in Physically Limited Obese Elderly Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2004-12'}, 'lastUpdateSubmitDate': '2006-05-02', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2006-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'physical function and body composition'}], 'secondaryOutcomes': [{'measure': 'quality of life, metabolic markers'}]}, 'conditionsModule': {'keywords': ['Obesity, Aging, Frailty, exercise, weight loss'], 'conditions': ['Obesity', 'Frailty', 'Elderly']}, 'referencesModule': {'references': [{'pmid': '15229329', 'type': 'BACKGROUND', 'citation': 'Villareal DT, Banks M, Siener C, Sinacore DR, Klein S. Physical frailty and body composition in obese elderly men and women. Obes Res. 2004 Jun;12(6):913-20. doi: 10.1038/oby.2004.111.'}, {'pmid': '16636211', 'type': 'RESULT', 'citation': 'Villareal DT, Banks M, Sinacore DR, Siener C, Klein S. Effect of weight loss and exercise on frailty in obese older adults. Arch Intern Med. 2006 Apr 24;166(8):860-6. doi: 10.1001/archinte.166.8.860.'}]}, 'descriptionModule': {'briefSummary': 'The overall purpose of this research is to determine the effect of weight loss and physical training on quality of life, physical function, metabolism, bone strength, body fat and muscle mass.', 'detailedDescription': 'Obesity causes serious medical complications and impairs quality of life. Moreover, in elderly persons, obesity can lead to frailty because of decreased strength, joint function, balance and mobility associated with aging. The primary objective of this study is to evaluate the effect of weight loss and physical training on physical function, body composition, metabolism and quality of life in frail, obese elderly men and women. Subjects are randomized to either control or 10% weight loss plus physical training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese (BMI 30 or greater) elderly (age 65 years or older) Frailty\n\nExclusion Criteria:\n\n* Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results. Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 yr, current use of bone acting drugs.'}, 'identificationModule': {'nctId': 'NCT00146133', 'briefTitle': 'Weight Loss and Exercise in Physically Limited Obese Elderly Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Effect of Weight Loss and Physical Training on Musculoskeletal Status, Physical Function, and Quality-of-Life in Physically Limited, Obese, Elderly Subjects', 'orgStudyIdInfo': {'id': 'KO7AG2116401'}, 'secondaryIdInfos': [{'id': 'KO7AG2116401'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'diet, exercise', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Dennis T Villareal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}}}}