Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 4:28 PM
Study NCT ID:
NCT00520858
Status:
COMPLETED
Last Update Posted:
2008-04-22
First Post:
2007-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise Modality on Abdominal Obesity and Health Risk Factors in Older Men and Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D015444', 'term': 'Exercise'}], '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': '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': {'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'lastUpdateSubmitDate': '2008-04-21', 'studyFirstSubmitDate': '2007-08-24', 'studyFirstSubmitQcDate': '2007-08-24', 'lastUpdatePostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal obesity', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Insulin Resistance', 'timeFrame': '6 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Abdominal Obesity']}, 'referencesModule': {'references': [{'pmid': '19171808', 'type': 'DERIVED', 'citation': 'Davidson LE, Hudson R, Kilpatrick K, Kuk JL, McMillan K, Janiszewski PM, Lee S, Lam M, Ross R. Effects of exercise modality on insulin resistance and functional limitation in older adults: a randomized controlled trial. Arch Intern Med. 2009 Jan 26;169(2):122-31. doi: 10.1001/archinternmed.2008.558.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of abdominal obesity in the elderly is increasing at alarming rates and thus, requires immediate attention. By comparison to younger adults, obesity reduction in the elderly presents a unique challenge and requires an innovative approach. We propose a novel approach to investigate the effects of different exercise types as independent treatment strategies for the reduction of obesity and related health risk factors in older men and women. We propose that exercise without caloric restriction will be associated with modest weight loss (3-5%), that in turn will be associated with significant reduction in abdominal obesity, insulin resistance, and a corresponding increase in skeletal muscle mass and function. We will determine the separate effects of resistance and aerobic exercise on these primary outcome variables, and, whether a treatment strategy that combines the two is optimal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women between 65 and 80 years of age.\n* Men and women are self-sufficient, sedentary, abdominally obese (BMI between 27 and 34.9 kg/m2; waist circumference greater than 88 cm in women and 102 cm in men), weight stable (± 2 kg) for 6 months prior to the beginning of the study, be non-smokers, and not diabetic.\n* We will study elderly women who are not taking hormone replacement therapy to create a homogeneous population in whom the effect of exercise on the principal outcome variables can be evaluated with minimal confounding.\n\nExclusion Criteria:\n\n* Smokers and diabetics.\n* Women taking hormone replacement therapy.'}, 'identificationModule': {'nctId': 'NCT00520858', 'briefTitle': 'Effects of Exercise Modality on Abdominal Obesity and Health Risk Factors in Older Men and Women', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Effects of Exercise Modality on Abdominal Obesity and Health Risk Factors in Older Men and Women', 'orgStudyIdInfo': {'id': 'Ross2002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'C'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RE', 'description': 'Resistance Exercise', 'interventionNames': ['Other: Resistance Exercise (RE)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AE', 'description': 'Aerobic Exercise', 'interventionNames': ['Other: Aerobic Exercise (AE)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RAE', 'description': 'Resistance and Aerobic', 'interventionNames': ['Other: Resistance and Aerobic Exercise (RAE)']}], 'interventions': [{'name': 'Resistance Exercise (RE)', 'type': 'OTHER', 'armGroupLabels': ['RE']}, {'name': 'Aerobic Exercise (AE)', 'type': 'OTHER', 'armGroupLabels': ['AE']}, {'name': 'Resistance and Aerobic Exercise (RAE)', 'type': 'OTHER', 'armGroupLabels': ['RAE']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 3N6', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Robert Ross', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}]}}}