Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-29 @ 12:01 PM
Study NCT ID:
NCT01453868
Status:
UNKNOWN
Last Update Posted:
2011-10-18
First Post:
2011-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Aerobics Training on Balance in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-10-17', 'studyFirstSubmitDate': '2011-10-13', 'studyFirstSubmitQcDate': '2011-10-17', 'lastUpdatePostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biodex Scale Balance score: Automated', 'timeFrame': 'Change: baseline and 12 weeks', 'description': 'A patient will step up to a Biodex Balance scale and will be instructed to try and maintain balance on the machine until it produces an automated outcome score for balance. This number is directly related to a fall risk score in patients with neurological compromise.'}], 'secondaryOutcomes': [{'measure': 'Pre and post intervention questionaire', 'timeFrame': 'Change: baseline and 12 weeks', 'description': 'A fifty question questionaire will be administered pre and post intervention. These questions will focus on mood changes, attitude changes and overall quality of life changes related to adding exercise in their daily living.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'non impact aerobics'], 'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nmmu.ac.za/', 'label': 'Nelson Mandela Metropole University, Port Elizabeth South Africa'}]}, 'descriptionModule': {'briefSummary': 'Standing Balance, with and without blindfold, will be measured on patients with Multiple Sclerosis using a Biodex Balance Scale.\n\nA Twelve week intervention with one non impact aerobics group and one control group will be performed.\n\nStanding balance will then be retested on all subjects and the results will be statistically compared.', 'detailedDescription': 'Standing Balance will be tested in 4 phases:\n\n* On a firm surface eyes open\n* On a frim surface eyes blindfolded\n* On a foam surface eyes open\n* On a foam surface eyes blindfolded\n\nThe aerobics classes will be conducted by a NIA (Non Impact Aerobics) instructor and will be a combination of tai chi, slow movement dancing, stretching and modified yoga stretches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that were diagnosed by a neurologist with Relapsing Remitting Multiple Sclerosis.\n* EDSS scale between 1 and 6.\n* Patients that are able to travel to and from a 12 week program location.\n\nExclusion Criteria:\n\n* Patients that were diagnosed by a neurologist with primary or secondary progressive multiple sclerosis.\n* EDSS scale above 6'}, 'identificationModule': {'nctId': 'NCT01453868', 'acronym': 'NIA', 'briefTitle': 'The Effects of Aerobics Training on Balance in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Nelson Mandela Metropolitan University'}, 'officialTitle': 'The Effects of Neuromuscular Training on Balance in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'H11-HEA-HMS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active non impact aerobics', 'description': 'This group will be performing a 12 week non impact aerobics program twice a week.', 'interventionNames': ['Other: Non Impact Aerobics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group: Passive lecture series', 'description': 'The control group will also be measured for balance and then attend a 12 week lecture series with no exercise. They will then also be remeasured post lectures series', 'interventionNames': ['Other: Passive : lecture series']}], 'interventions': [{'name': 'Non Impact Aerobics', 'type': 'OTHER', 'otherNames': ['Dancing, NIA, MS'], 'description': 'a 12 week, twice a week class in non impact aerobics', 'armGroupLabels': ['Active non impact aerobics']}, {'name': 'Passive : lecture series', 'type': 'OTHER', 'otherNames': ['Lifestyle lectures, symptom management'], 'description': 'a 12 week, once a week for one hour lecture series with no exercise. Topics will cover symptom management in Multiple Sclerosis', 'armGroupLabels': ['Control group: Passive lecture series']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49735', 'city': 'Gaylord', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donovan Adendorf, DC', 'role': 'CONTACT', 'email': 'adendorf@msn.com', 'phone': '989-731-2948'}, {'name': 'Donovan Adendorf, DC', 'role': 'CONTACT', 'email': 'adendorff@hotmail.com', 'phone': '989-732 1533'}, {'name': 'Donovan Adendorf, DC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HealthZone Chiropractic Clinic', 'geoPoint': {'lat': 45.02751, 'lon': -84.67475}}], 'centralContacts': [{'name': 'Donovan Adendorf, DC', 'role': 'CONTACT', 'email': 'adendorf@msn.com', 'phone': '989-731 2948'}, {'name': 'Donovan Adendorf', 'role': 'CONTACT', 'email': 'adendorf@msn.com', 'phone': '989-858 2345'}], 'overallOfficials': [{'name': 'Donovan Adendorf, DC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nelson Mandela Metropole University, Department of Health Sciences'}, {'name': 'Rosa DuRandt, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor: Human Movement Sciences, NMMU-Port Elizabeth South Africa'}, {'name': 'Maryna Baard, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Helath Sciences-NMMU, Port Elizabeth South Africa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nelson Mandela Metropolitan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Donovan Adendorf', 'investigatorFullName': 'Dr. Donovan Adendorf', 'investigatorAffiliation': 'Nelson Mandela Metropolitan University'}}}}