Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-30 @ 12:14 AM
Study NCT ID:
NCT02335450
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2015-01-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Theory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case Series
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bblack@oakland.edu', 'phone': '248-364-8694', 'title': 'Beth Black', 'organization': 'Oakland University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a small case series qualitative design study.'}}, 'adverseEventsModule': {'timeFrame': '5 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm', 'description': "The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor to wear during the day for four weeks and maintain a daily physical activity log to track their progress in meeting their activity goals.\n\nEach week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week.", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Steps Taken Over Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': "The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor and fill out a daily physical activity log to track their progress in meeting their activity goals. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week."}], 'classes': [{'categories': [{'measurements': [{'value': '296,147', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Wristband physical activity monitor recorded steps taken by participant over the 4 weeks of the study. No minimum or maximum. No baseline taken so cannot compare pre-intervention to post intervention.', 'unitOfMeasure': 'steps over 4 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 3 of the 4 participants who completed the study were included in the step total. One participant walked too slowly due to her disease to trigger the wristband step monitor.'}, {'type': 'SECONDARY', 'title': 'Exercise Self-Efficacy Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Mean Baseline Score', 'description': 'The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor to wear during the day for four weeks to track their progress in meeting their activity goals and keep a daily physical activity log.'}, {'id': 'OG001', 'title': 'Single Arm Mean Post-study Score', 'description': 'The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor to wear during the day for four weeks to track their progress in meeting their activity goals and keep a daily physical activity log.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.65', 'groupId': 'OG000', 'lowerLimit': '58.30', 'upperLimit': '100'}, {'value': '91.75', 'groupId': 'OG001', 'lowerLimit': '77.00', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at end of 4-week intervention', 'description': 'The "Exercise Self-Efficacy Scale" is the participant\'s self-reported confidence in their ability to engage in exercise throughout the day. Each of the 6 items is scored from 0% confidence to 100% confidence. All items are summed and the score is divided by 6 Minimum score: 0 Maximum score:100 Higher scores mean a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The 4 participants who completed the study had baseline and end of study exercise self-efficacy measured.'}, {'type': 'SECONDARY', 'title': 'Multiple Sclerosis Self-Efficacy Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Mean Baseline Score', 'description': "The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor and fill out a daily physical activity log to track their progress in meeting their activity goals. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week."}, {'id': 'OG001', 'title': 'Single Arm Mean Post-study Score', 'description': "The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor and fill out a daily physical activity log to track their progress in meeting their activity goals. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week."}], 'classes': [{'categories': [{'measurements': [{'value': '48.25', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '69'}, {'value': '47.25', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '66'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline compared to end of 4-week study', 'description': 'The "Multiple Sclerosis Self-Efficacy Scale" is a self-report of impact of multiple sclerosis on quality of life. The 14 statements are answered by selecting one of six options from strongly disagree to strongly agree.\n\nMinimum value: 14 Maximum value: 84 Higher scores reflect mean a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The 4 participants who competed the study had post-study scores compared to baseline scores.'}, {'type': 'SECONDARY', 'title': 'Multiple Sclerosis Impact Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Baseline Mean Score', 'description': "The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor and fill out a daily physical activity log to track their progress in meeting their activity goals. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week."}, {'id': 'OG001', 'title': 'Single Arm Post-study Mean Score', 'description': "The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor and fill out a daily physical activity log to track their progress in meeting their activity goals. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week."}], 'classes': [{'categories': [{'measurements': [{'value': '78.25', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '109'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '77'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline compared to end of 4-week study', 'description': 'The "Multiple Sclerosis Impact Scale" is a self-report on how multiple sclerosis has impacted day-to-day life during the past 2 weeks. The 29 items are graded by the participants on a 5 point scale rating from "not at all" to "extremely".\n\nMinimum score: 29 Maximum Score:145 Higher scores mean worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The 4 participants who completed the study had their end of study score compared to their baseline score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm', 'description': 'The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor to wear during the day for four weeks to track their progress in meeting their activity goals and keep a daily physical activity log.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm', 'description': 'All five participants had multiple sclerosis (MS). Four participants had relapsing-remitting MS and one participant had progressive-relating MS. Years since diagnosis of MS ranged from 9 years to 29 years.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '69'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'All 5 participants completed baseline questionnaires.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'All 5 participants completed baseline questionnaires.'}, {'title': 'Exercise Self-Efficacy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '72.58', 'groupId': 'BG000', 'lowerLimit': '58.3', 'upperLimit': '100.00'}]}]}], 'paramType': 'MEAN', 'description': 'The Exercise Self-Efficacy Scale contains 6 statements asking respondents to indicate their level of confidence that they can exercise three times per week for a period of one month, two months, three months, four months, five months and six months. For each of these 6 statements, the respondent selects one answer from 10% increments from 0% to 100%. The responses for all statements are summed and the number is divided by 6.\n\nThe minimum score is 0, the maximum score is 100. Higher values represent a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Multiple Sclerosis Impact Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '73.8', 'groupId': 'BG000', 'lowerLimit': '37.0', 'upperLimit': '109.0'}]}]}], 'paramType': 'MEAN', 'description': "The Multiple Sclerosis Impact Scale (MSIS-29) consists of 29 questions about the impact of multiple sclerosis on the respondent's life during the past two weeks. For each question, the respondent circles the one best number that best describes their situation. The number 1 = Not at all, 2= A little, 3= Moderately, 4= Quite a bit, 5= Extremely. The scores are summed.\n\nScores range from 29 to 145. Higher numbers represent a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Multiple Sclerosis Self-Efficacy Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'BG000', 'lowerLimit': '40.0', 'upperLimit': '69.0'}]}]}], 'paramType': 'MEAN', 'description': 'The Multiple Sclerosis Self-Efficacy Scale is a self-report of psychological adjustment and quality of life of individuals with MS. The 14 statements are answered by selecting one of 6 options ranging from strongly disagree to strongly agree. The range of scores is 14 to 84. Higher scores mean better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'All 5 participants completed baseline questionnaires.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2015-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-01', 'studyFirstSubmitDate': '2015-01-07', 'resultsFirstSubmitDate': '2019-03-13', 'studyFirstSubmitQcDate': '2015-01-07', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-23', 'studyFirstPostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Steps Taken Over Course of the Study', 'timeFrame': '4 weeks', 'description': 'Wristband physical activity monitor recorded steps taken by participant over the 4 weeks of the study. No minimum or maximum. No baseline taken so cannot compare pre-intervention to post intervention.'}], 'secondaryOutcomes': [{'measure': 'Exercise Self-Efficacy Questionnaire', 'timeFrame': 'baseline and at end of 4-week intervention', 'description': 'The "Exercise Self-Efficacy Scale" is the participant\'s self-reported confidence in their ability to engage in exercise throughout the day. Each of the 6 items is scored from 0% confidence to 100% confidence. All items are summed and the score is divided by 6 Minimum score: 0 Maximum score:100 Higher scores mean a better outcome.'}, {'measure': 'Multiple Sclerosis Self-Efficacy Scale', 'timeFrame': 'baseline compared to end of 4-week study', 'description': 'The "Multiple Sclerosis Self-Efficacy Scale" is a self-report of impact of multiple sclerosis on quality of life. The 14 statements are answered by selecting one of six options from strongly disagree to strongly agree.\n\nMinimum value: 14 Maximum value: 84 Higher scores reflect mean a better outcome.'}, {'measure': 'Multiple Sclerosis Impact Scale', 'timeFrame': 'baseline compared to end of 4-week study', 'description': 'The "Multiple Sclerosis Impact Scale" is a self-report on how multiple sclerosis has impacted day-to-day life during the past 2 weeks. The 29 items are graded by the participants on a 5 point scale rating from "not at all" to "extremely".\n\nMinimum score: 29 Maximum Score:145 Higher scores mean worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['exercise', 'motivational interviewing'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '25160577', 'type': 'BACKGROUND', 'citation': 'Borkoles E, Nicholls AR, Bell K, Butterly R, Polman RC. The lived experiences of people diagnosed with multiple sclerosis in relation to exercise. Psychol Health. 2008;23(4):427-41. doi: 10.1080/14768320701205309.'}, {'pmid': '19903131', 'type': 'BACKGROUND', 'citation': 'Stroud N, Minahan C, Sabapathy S. The perceived benefits and barriers to exercise participation in persons with multiple sclerosis. Disabil Rehabil. 2009;31(26):2216-22. doi: 10.3109/09638280902980928.'}, {'pmid': '19619337', 'type': 'BACKGROUND', 'citation': 'Stroud NM, Minahan CL. The impact of regular physical activity on fatigue, depression and quality of life in persons with multiple sclerosis. Health Qual Life Outcomes. 2009 Jul 20;7:68. doi: 10.1186/1477-7525-7-68.'}, {'pmid': '15165658', 'type': 'BACKGROUND', 'citation': 'Rimmer JH, Riley B, Wang E, Rauworth A, Jurkowski J. Physical activity participation among persons with disabilities: barriers and facilitators. Am J Prev Med. 2004 Jun;26(5):419-25. doi: 10.1016/j.amepre.2004.02.002.'}, {'pmid': '24453744', 'type': 'BACKGROUND', 'citation': 'Brown C, Kitchen K, Nicoll K. Barriers and facilitators related to participation in aquafitness programs for people with multiple sclerosis: a pilot study. Int J MS Care. 2012 Fall;14(3):132-41. doi: 10.7224/1537-2073-14.3.132.'}, {'pmid': '23599354', 'type': 'BACKGROUND', 'citation': 'Motl RW, McAuley E, Sandroff BM. Longitudinal change in physical activity and its correlates in relapsing-remitting multiple sclerosis. Phys Ther. 2013 Aug;93(8):1037-48. doi: 10.2522/ptj.20120479. Epub 2013 Apr 18.'}, {'pmid': '16042230', 'type': 'BACKGROUND', 'citation': 'Motl RW, McAuley E, Snook EM. Physical activity and multiple sclerosis: a meta-analysis. Mult Scler. 2005 Aug;11(4):459-63. doi: 10.1191/1352458505ms1188oa.'}, {'pmid': '14742602', 'type': 'BACKGROUND', 'citation': 'McGuigan C, Hutchinson M. The multiple sclerosis impact scale (MSIS-29) is a reliable and sensitive measure. J Neurol Neurosurg Psychiatry. 2004 Feb;75(2):266-9.'}, {'pmid': '12617272', 'type': 'BACKGROUND', 'citation': 'Rigby SA, Domenech C, Thornton EW, Tedman S, Young CA. Development and validation of a self-efficacy measure for people with multiple sclerosis: the Multiple Sclerosis Self-efficacy Scale. Mult Scler. 2003 Feb;9(1):73-81. doi: 10.1191/1352458503ms870oa.'}, {'pmid': '12900694', 'type': 'BACKGROUND', 'citation': 'Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.'}, {'pmid': '1574662', 'type': 'BACKGROUND', 'citation': 'Marcus BH, Selby VC, Niaura RS, Rossi JS. Self-efficacy and the stages of exercise behavior change. Res Q Exerc Sport. 1992 Mar;63(1):60-6. doi: 10.1080/02701367.1992.10607557.'}, {'pmid': '24942478', 'type': 'BACKGROUND', 'citation': "O'Halloran PD, Blackstock F, Shields N, Holland A, Iles R, Kingsley M, Bernhardt J, Lannin N, Morris ME, Taylor NF. Motivational interviewing to increase physical activity in people with chronic health conditions: a systematic review and meta-analysis. Clin Rehabil. 2014 Dec;28(12):1159-71. doi: 10.1177/0269215514536210. Epub 2014 Jun 18."}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of personalized physical activity coaching combined with the use of a physical activity monitor to support increased levels of daily physical activity in individuals with multiple sclerosis. All five participants will receive the intervention over the four week intervention phase.', 'detailedDescription': 'Individuals with multiple sclerosis engage in less daily physical activity than the general population for a variety of reasons. This research project is intended to evaluate whether individualized coaching combined with the use of a Fitbit physical activity wristband monitor will improve physical activity levels in individuals with multiple sclerosis.\n\nFollowing admission into the study, participants will be visited once a week for four weeks at home by a physical therapist. The participants in consultation with the physical therapist will set daily physical activity goals for the following week and the participants will be taught how to monitor their daily activity using a Fitbit physical activity wristband.\n\nThe goals of this study are to determine whether this intervention is effective in helping participants increase their levels of daily physical activity and their confidence that they can successfully engage in daily physical activity. In addition, there will be an evaluation of changes from pre-intervention to post-intervention in quality of life measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must have a physician diagnosis of multiple sclerosis and deemed suitable for engaging in a physical activity program by their physician\n* must be ambulatory with or without an assistive device\n* must be able to speak and read English\n* must have a home computer or device capable of tracking and recording the daily Fitbit physical activity reports\n\nExclusion Criteria:\n\n* participants will be excluded if any contraindications to engaging in independent exercise are identified during the intake examination by the physical therapist: cardiovascular issues or safety issues with walking.'}, 'identificationModule': {'nctId': 'NCT02335450', 'briefTitle': 'Theory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case Series', 'organization': {'class': 'OTHER', 'fullName': 'Oakland University'}, 'officialTitle': 'Theory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case Series', 'orgStudyIdInfo': {'id': '619511-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'description': 'All five participants in the study will receive this intervention. The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use a coaching technique called motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor to wear during the day for four weeks to track their progress in meeting their activity goals.', 'interventionNames': ['Behavioral: Motivational Interviewing', 'Device: Wristband physical activity monitor']}], 'interventions': [{'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'otherNames': ['Coaching'], 'description': "The participant will describe their unique physical activity challenges and their physical activity goals with the physical therapist. Using the technique of motivational interviewing, the physical therapist will work with the participant to help identify potential solutions to challenges and set realistic activity goals for the next week. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week.", 'armGroupLabels': ['Single Arm']}, {'name': 'Wristband physical activity monitor', 'type': 'DEVICE', 'description': "The participant will wear a Fitbit wristband which will track the participant's daily steps and minutes of physical activity.", 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48309', 'city': 'Rochester', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oakland University', 'geoPoint': {'lat': 42.68059, 'lon': -83.13382}}], 'overallOfficials': [{'name': 'Beth Black, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oakland University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Information will be shared 6 months after publication for one year.', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication', 'accessCriteria': 'Principal investigator will consider written request for study protocol and results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oakland University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst Prof Physical Therapy, Health Sciences', 'investigatorFullName': 'Beth Black', 'investigatorAffiliation': 'Oakland University'}}}}