Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 10:10 PM
Study NCT ID:
NCT01824550
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2013-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Exercise Intervention in Persons With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2013-04-01', 'studyFirstSubmitQcDate': '2013-04-01', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Disease state, and fatigue', 'timeFrame': '3 months', 'description': 'This will be measured via questionnaires'}], 'primaryOutcomes': [{'measure': 'Subclinical atherosclerosis', 'timeFrame': '3 months', 'description': 'This will me measured through carotid intima media thickness, flow mediated dilation of forearm, and aortic pulse wave velocity'}], 'secondaryOutcomes': [{'measure': 'Mobility disability', 'timeFrame': '3 months', 'description': 'This will be measured by the 6-min walk, 25 ft walk, the "Get-up-and-go" test and by gait characteristics.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the effect of home-based, aerobic exercise training on subclinical atherosclerosis and mobility disability in persons with Multiple Sclerosis (MS). Our central hypothesis is that aerobic exercise training reduces both subclinical atherosclerosis and mobility disability.', 'detailedDescription': 'This study will use a two-arm randomized control trial (RCT) design to examine the effect of a home-based exercise training program versus a minimal exercise, attention control condition on markers of subclinical atherosclerosis and mobility disability in persons with MS. The primary outcomes will be subclinical atherosclerosis including measures of arterial structure and function and measures of mobility disability including the six-minute walk and timed 25-foot walk, GaitRite walking assessment and one week of accelerometry data.\n\nFifty-four persons with MS who have an Expanded Disability Status Score (EDSS) score between 0 and 4.0 will be randomized into either the home-based exercise training condition or the attention control condition. Participation in this study will include a 3-month exercise program to be completed at home. In addition, participants will need to come to University of Illinois at Chicago (UIC) three times to undergo testing. Each visit will take about 3-4 hours to complete. Testing that will take place during these three visits include blood pressure measurement, six vascular (artery) measurements, heart measurements, short walking tests, peak aerobic capacity test, blood draw, five quality of Life questionnaires and two cognitive function tests.\n\nThe home-based exercise regimen will include cycle ergometry as an aerobic mode of training 3 times per week with a gradual progression of duration and intensity across a 12-week period. Exercise prescription will be based on the peak aerobic capacity cycling test conducted during the first visit. The attention control will involve stretching using the same frequency and duration across a 12-week period with exercises recommended by the National Multiple Sclerosis Society (NMSS). Both arms will receive weekly internet "coaching" sessions via video chatting.\n\nSubclinical atherosclerosis and mobility disability data will be collected before, after 6 weeks of training and immediately after the 12-week intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physically inactive\n* BMI\\<40\n* 1st stage of MS (i.e., defined as EDSS score of 0 - 4.0)\n* independently ambulatory (walking without an assistive device such as a cane or orthotic)\n* relapse free in the past 30 days\n* confirmed diagnosis of MS\n* asymptomatic (i.e., no underlying clinically diagnosed cardiovascular disease)\n* be on a stable disease modifying therapy\n* physician approval for undertaking exercise testing and training'}, 'identificationModule': {'nctId': 'NCT01824550', 'acronym': 'HOMS', 'briefTitle': 'Home Exercise Intervention in Persons With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Exercise, Subclinical Atherosclerosis and Walking Mobility in Multiple Sclerosis', 'orgStudyIdInfo': {'id': '2012-0836'}, 'secondaryIdInfos': [{'id': 'RG 4702A1/2', 'type': 'OTHER_GRANT', 'domain': 'NMSS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'home-based exercise training condition', 'description': 'Home based endurance exercise training', 'interventionNames': ['Other: home-based exercise training condition']}, {'type': 'NO_INTERVENTION', 'label': 'attention control condition', 'description': 'Attention control condition - home based flexibility training'}], 'interventions': [{'name': 'home-based exercise training condition', 'type': 'OTHER', 'description': 'Home based endurance exercise training', 'armGroupLabels': ['home-based exercise training condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Bo Fernhall, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dean and Professor', 'investigatorFullName': 'Bo Fernhall', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}