Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT00866112
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
2009-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Exercise Trial for Wheelchair Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D016135', 'term': 'Spinal Dysraphism'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D009436', 'term': 'Neural Tube Defects'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-13', 'studyFirstSubmitDate': '2009-03-19', 'studyFirstSubmitQcDate': '2009-03-19', 'lastUpdatePostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weekly minutes spent in aerobic and strengthening activity', 'timeFrame': 'Baseline, 12, 26 and 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Wheelchair use', 'Spinal cord injury', 'Multiple sclerosis', 'Muscular dystrophy', 'Cerebral palsy', 'Spina bifida', 'Amputation', 'Arthritis', 'Stroke'], 'conditions': ['Spinal Cord Injury', 'Multiple Sclerosis', 'Muscular Dystrophy', 'Cerebral Palsy', 'Spina Bifida', 'Amputation', 'Arthritis', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '22609118', 'type': 'DERIVED', 'citation': "Froehlich-Grobe K, Nary DE, VanSciver A, Washburn RA, Aaronson L. Truth be told: evidence of wheelchair users' accuracy in reporting their height and weight. Arch Phys Med Rehabil. 2012 Nov;93(11):2055-61. doi: 10.1016/j.apmr.2012.05.005. Epub 2012 May 15."}, {'pmid': '21035565', 'type': 'DERIVED', 'citation': 'Nary DE, Froehlich-Grobe K, Aaronson L. Recruitment issues in a randomized controlled exercise trial targeting wheelchair users. Contemp Clin Trials. 2011 Mar;32(2):188-95. doi: 10.1016/j.cct.2010.10.010. Epub 2010 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'People with mobility disabilities are at greater risk than the general population for incurring health problems. Many of these conditions are preventable through behavior and lifestyle changes such as exercise and physical activity. Recent evidence suggests that people with disabilities experience the same physiologic response to exercise as the general population. Nonetheless, nearly three-fourths of those with disabilities report being entirely sedentary or not active enough to achieve health benefits. Despite some knowledge of issues that limit physical activity among this population, few studies have investigated methods for promoting physical activity adoption among people with disabilities, including wheelchair users. The purpose of this study is to test the effectiveness of a behavioral intervention to promote physical activity adoption over 6 months and maintenance of physical activity over another 6 months by community-dwelling manual wheelchair users.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be experiencing a permanent disability of at least 6 months that limits mobility sufficiently to require use of a wheelchair as the primary method of mobility outside the home\n* Have not been moderately to vigorously physically active for the past 6 months\n* Be willing to attend the educational workshop\n* Receive physician approval for participation\n\nExclusion criteria include:\n\n* Presence of medical conditions such as uncontrolled cardiovascular problems that the patient's physician identifies as being contraindicated for exercise\n* Pregnancy or planning to become pregnant"}, 'identificationModule': {'nctId': 'NCT00866112', 'briefTitle': 'A Randomized Exercise Trial for Wheelchair Users', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'A Randomized Exercise Trial for Wheelchair Users', 'orgStudyIdInfo': {'id': '10053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Intervention group to promote physical activity', 'interventionNames': ['Other: Educational session to promote physical activity']}, {'type': 'OTHER', 'label': '2', 'description': 'Minimal contact control group', 'interventionNames': ['Other: Minimal contact']}], 'interventions': [{'name': 'Educational session to promote physical activity', 'type': 'OTHER', 'description': 'Educational session, goal setting, self monitoring of daily engagement in physical activity', 'armGroupLabels': ['1']}, {'name': 'Minimal contact', 'type': 'OTHER', 'description': 'Self guided education manual about adopting physical activity, self monitor daily engagement in physical activity', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66045', 'city': 'Lawrence', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas', 'geoPoint': {'lat': 38.97167, 'lon': -95.23525}}], 'overallOfficials': [{'name': 'Katherine Froehlich-Grobe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assitant Professor', 'investigatorFullName': 'Kathleen Grobe', 'investigatorAffiliation': 'University of Kansas'}}}}