Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT06933160
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promotion of Exercise Through Physical Therapy for Multiple Sclerosis: A Pilot Study
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-04-05', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accelerometer-measured moderate-to-vigorous physical activity', 'timeFrame': 'From enrolment to end of treatment at 24 weeks', 'description': 'The duration (in minutes per day) of moderate-to-vigorous physical activity (MVPA) will be assessed using a waist-worn accelerometer (ActiGraph model GT3X+). Participants will wear the accelerometer attached to a belt around their waist during waking hours over a 7-day period. A greater duration of MVPA indicates a higher level of physical activity.'}], 'secondaryOutcomes': [{'measure': 'Total physical activity', 'timeFrame': 'From enrolment to end of treatment at 24 weeks', 'description': 'The duration (in minutes per day) of physical activity (light, moderate, and vigorous activity) will be assessed using a waist-worn accelerometer (ActiGraph model GT3X+). Participants will wear the accelerometer attached to a belt around their waist during waking hours over a 7-day period. A greater duration of physical activity indicates a higher level of physical activity.'}, {'measure': 'Fatigue', 'timeFrame': 'From enrolment to end of treatment at 24 weeks', 'description': 'PROMIS Fatigue CAT'}, {'measure': 'Physical Function', 'timeFrame': 'From enrolment to end of treatment at 24 weeks', 'description': 'PROMIS Physical Function CAT'}, {'measure': 'Exercise Self-efficacy', 'timeFrame': 'From enrolment to end of treatment at 24 weeks', 'description': 'Exercise Self-efficacy scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'physical activity', 'exercise', 'physical therapy'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Physical activity and exercise help manage symptoms like fatigue in people living with multiple sclerosis (MS). Despite research supporting physical activity participation, people with MS are often insufficiently active to reach health benefits. Promotional efforts that are sustainable within the United States healthcare system are needed. This project is a pilot randomized controlled trial examining the feasibility of a consultative physical therapy intervention for increasing physical activity engagement.', 'detailedDescription': 'Multiple sclerosis is a debilitating disease usually diagnosed between the ages of 20 and 49 years with no curative options, resulting in a focus on rehabilitation strategies to manage symptoms, restore function, and improve quality of life. Physical activity, particularly exercise training, is considered one of the best rehabilitation strategies for comprehensive multiple sclerosis management. Despite strong evidence of the safety and benefits of physical activity and exercise in this population, persons with multiple sclerosis do not engage in sufficient levels of physical activity. Physical therapists are well positioned and have the expertise to facilitate physical activity and exercise participation for persons with multiple sclerosis. However, physical therapy is underutilized, particularly in people with more mild multiple sclerosis symptoms, when the best results may be achieved. A proactive physical therapy delivery model may help persons with multiple sclerosis increase and maintain their physical activity and exercise behaviors. The proposed study involves 1) a randomized controlled trial to evaluate outcomes of feasibility in the four metrics of process, resources, management, and scientific outcomes, and 2) an assessment of the immediate and sustained treatment effect of the physical therapy model compared to a waitlist control on accelerometer-measured physical activity. The feasibility trial will be conducted with a sample of 40 persons with multiple sclerosis randomized to either the intervention or waitlist control group. Participants will complete assessments at baseline, post-intervention (6 months), and follow-up (10 months). Participants will complete a formative evaluation, including surveys and one-on-one semi-structured interviews, to assess satisfaction, acceptability, feasibility, and appropriateness of the physical therapy delivery model. The proposed feasibility study, interviews, and implementation assessments will directly lead to the submission of an R01 to test the efficacy of an appropriately powered randomized controlled trial and to identify context-specific barriers and facilitators to the successful uptake of this physical therapy model in clinical settings. The dissemination of the results of this feasibility study can lead to improvements in physical therapy delivery for persons with multiple sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of MS\n* 18 years and older\n* Able to read and speak English sufficiently to allow for informed consent and active participation in the intervention sessions\n* Relapse free for the past 30 days\n* Willingness to attend all study visits and PT sessions for the duration of study\n* Access to a smartphone\n* Not sufficiently active as measured by the Godin Leisure Time Exercise Questionnaire score \\<24\n* Patient Determined Disease Steps score 0-3 or the ability to ambulate either independently or with the use of a cane (or similar device) for at least 75% of the time at baseline\n* Less than 2 affirmative on the physical activity readiness questionnaire\n\nExclusion Criteria:\n\n* Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)\n* Unable to attend study visits\n* Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol.'}, 'identificationModule': {'nctId': 'NCT06933160', 'acronym': 'PromPT-MS', 'briefTitle': 'Promotion of Exercise Through Physical Therapy for Multiple Sclerosis: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Promotion of Exercise for Multiple Sclerosis Through Physical Therapy (PromPT)', 'orgStudyIdInfo': {'id': 'HUM00266361'}, 'secondaryIdInfos': [{'id': '1R03HD111005-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R03HD111005-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'The experimental intervention is a 24-week progressive exercise intervention in which participants are supported through six physical therapy visits and are provided with educational material based on social cognitive theory. The individual sessions will provide tailored support for increasing physical activity behavior towards the recommended guidelines of 2-3 moderate aerobic activity sessions and two strength-training sessions per week. There are no drugs involved in the intervention.', 'interventionNames': ['Behavioral: PromPT-MS']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control', 'description': '24-week waitlist control condition'}], 'interventions': [{'name': 'PromPT-MS', 'type': 'BEHAVIORAL', 'description': 'The experimental intervention is a 24-week progressive exercise intervention in which participants are supported through six physical therapy visits and are provided with educational material based on social cognitive theory. The individual sessions will provide tailored support for increasing physical activity behavior towards the recommended guidelines of 2-3 moderate aerobic activity sessions and two strength-training sessions per week. There are no drugs involved in the intervention.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dominique Kinnett-Hopkins', 'role': 'CONTACT', 'email': 'dlkh@umich.edu', 'phone': '734-647-5424'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Dominique Kinnett-Hopkins', 'role': 'CONTACT', 'email': 'dlkh@umich.edu', 'phone': '734-647-5424'}], 'overallOfficials': [{'name': 'Dominique Kinnett-Hopkins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Kinesiology, School of Kinesiology', 'investigatorFullName': 'Dominique Kinnett-Hopkins', 'investigatorAffiliation': 'University of Michigan'}}}}