Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-01-28 @ 7:09 PM
Study NCT ID:
NCT02100020
Status:
COMPLETED
Last Update Posted:
2018-05-31
First Post:
2014-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementing Physical Activity Guidelines for Adults With MS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-29', 'studyFirstSubmitDate': '2014-03-24', 'studyFirstSubmitQcDate': '2014-03-26', 'lastUpdatePostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to the Physical Activity Guidelines', 'timeFrame': '3 years', 'description': 'Adherence to the physical activity guidelines will be analyzed by having participants fill in a weekly physical activity log that will be sent to them by email.'}], 'secondaryOutcomes': [{'measure': 'Physical Fitness', 'timeFrame': 'At baseline and after the 16 week intervention', 'description': 'Peak oxygen uptake, maximum muscle strength, bodyweight'}, {'measure': 'Perceived Quality of Life', 'timeFrame': 'At baseline and after the 16 week intervention', 'description': 'Multiple Sclerosis Quality of Life (MSQoL) scale'}, {'measure': 'Fatigue', 'timeFrame': 'At baseline and after the 16 week intervention', 'description': 'Multiple Sclerosis Fatigue Impact Scale (MSFIS)'}, {'measure': 'Mobility', 'timeFrame': 'At baseline and after the 16 week intervention', 'description': '25ft walk test'}, {'measure': 'Blood markers of cardiovascular disease risk', 'timeFrame': 'At baseline and after the 16 week intervention', 'description': 'blood lipid panel, HbA1c, fasting glucose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['physical activity', 'exercise guidelines', 'multiple sclerosis'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '31675636', 'type': 'DERIVED', 'citation': 'Canning KL, Hicks AL. Physician referral improves adherence to the physical activity guidelines for adults with MS: A randomized controlled trial. Mult Scler Relat Disord. 2020 Jan;37:101441. doi: 10.1016/j.msard.2019.101441. Epub 2019 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'The proposed project will evaluate two methods of implementation of the new Physical Activity Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities. The investigators will also determine if following the PAGs will improve aspects of fitness, function, quality of life and risk for cardiometabolic disease in this population. The investigators hypothesize that adherence to the PAGs will be higher in people who have been referred directly to a community-based exercise program, and that this greater adherence to physical activity will be associated with greater improvements in fitness, function and quality of life.\n\nThis randomized controlled trial will provide important information on how best to implement physical activity recommendations within the community setting; this information will be translated to key stakeholders during the final stages of the project.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of MS with mild-moderate disability (EDSS 1-7)\n* Aged 18-60\n* Medical clearance to participate in physical activity\n\nExclusion Criteria:\n\n* current participation in regular physical activity (at least twice-weekly)\n* other serious medical condition that might impair ability to participate in strength or aerobic exercise'}, 'identificationModule': {'nctId': 'NCT02100020', 'briefTitle': 'Implementing Physical Activity Guidelines for Adults With MS', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'A Community-based Randomized Controlled Trial Testing Implementation of the New Canadian Physical Activity Guidelines for Adults With Multiple Sclerosis.', 'orgStudyIdInfo': {'id': 'MSProject2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Direct Referral to Physical Activity', 'description': 'The REF group will be referred to a centre-based community exercise program in their respective community (either the MacWheelers or Revved Up) by a clinical neurologist where they will be prescribed exercise based on the PAGs for adults with MS, and according to their individual capabilities.', 'interventionNames': ['Other: Direct Referral to physical activity']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The CON group will be provided with a print copy of the PAGs and a link to an online resource for physical activity information.'}], 'interventions': [{'name': 'Direct Referral to physical activity', 'type': 'OTHER', 'description': 'Participants randomized to the Direct Referral to Physical Activity Arm will be provided with a referral to a physical activity program in their community and will be closely monitored in this program for 16 wks.', 'armGroupLabels': ['Direct Referral to Physical Activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 4K1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University, Physical Activity Centre for Excellence', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 3N6', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Queens University', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Audrey L Hicks, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}