Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-25 @ 8:32 PM
Study NCT ID:
NCT06583967
Status:
RECRUITING
Last Update Posted:
2024-09-04
First Post:
2024-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Aerobic Exercise on an Elliptical Trainer Versus a Treadmill, in People with Multiple Sclerosis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}], 'ancestors': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will assess the effect of 12 weeks of aerobic exercise on an elliptical trainer (group 1) vs a treadmill (group 2), on gait and walking abilities, expressed in dynamic stability, balance and walking speed, in people with Multiple Sclerosis.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-01', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-09-01', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life outcomes', 'timeFrame': 'Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)', 'description': 'Quality of life to be assessed by using a Short-form 36 health status questionnaire (SF-36). SF-36 consists of 36 questions in total. Each participant will be asked to fill in the questionnaire alone and by reading it themselves.'}], 'secondaryOutcomes': [{'measure': '6 Minute Walk Test (6MWT)', 'timeFrame': 'Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)', 'description': 'Each subject will be asked to perform a 6 min walk and the max distance to be measured,'}, {'measure': 'Timed Up & Go (TUG)', 'timeFrame': 'Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)', 'description': 'Patients wear their regular footwear and can use a walking aid, if needed. The patient stands up upon therapist\\'s command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated'}, {'measure': 'Berg Balance Scale (BBS)', 'timeFrame': 'Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)', 'description': 'The Berg Balance Scale (BBS) is used to objectively determine a patient\\'s ability (or inability) to safely balance during a series of predetermined tasks.'}, {'measure': '10 Meter Walk Test (10MWT)', 'timeFrame': 'Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)', 'description': 'The 10 Metre Walk Test is a performance measure used to assess walking or gait speed in meters per second over a short distance'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aerobic', 'Exercise', 'Elliptical trainer', 'Treadmill', '6 Minute Walk Test (6MWT)', 'Timed Up & Go (TUG)', 'Berg Balance Scale (BBS)', '10 Meter Walk Test (10MWT)', 'Informed Consent Form (ICF)'], 'conditions': ['Multiple Sclerosis (MS)']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effects of aerobic exercise training using an elliptical trainer compared to a treadmill on gait and walking abilities, expressed in dynamic stability, balance, and walking speed, in people with Multiple Sclerosis with moderate severity.', 'detailedDescription': 'A total of 30 MS subjects to be enrolled in the study. Subjects to be assigned into one of two groups named: Group 1 - Elliptical Training and Group 2 - Treadmill Training. Effort capacity will measured by heart rate and RPE.\n\nOutcome measures will be measured by using, 6 min. walking test (6MWT), Timed Up \\& Go (TUG), Berg Balance Scale (BBS) and 10 Meter Walk Test (10MWT) to be used to assess the quality of life at Baseline (T0), During study - 6 weeks from baseline (T1), End of training program - 12 weeks from baseline (T2) and 6 weeks post T2 (T3).\n\nThe exercise program to be applied for 12 weeks with 2 trainings per week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients signed Informed Consent Form\n2. At least 6 months post MS diagnosis\n3. 25-55 years old adults\n4. EDSS 3.0-6.5\n5. Standing stability - for at least 30 seconds\n6. 6MWT - minimal distance to be measured as 210 meters\n7. No physical routinely training e.g. walking, elliptical or cycling within 3 months prior screening visit.\n\nExclusion Criteria:\n\n1. Active Heart Disease\n2. Lungs and/or respiratory system diseases\n3. Metabolic Disease\n4. Any other medical condition(s) which might impact the patient's participant in the study, as per PI medical judgement\n5. Major medical treatment change (as per PI medical judgement) up to 12 weeks prior ICF signature by the patient."}, 'identificationModule': {'nctId': 'NCT06583967', 'acronym': 'MS', 'briefTitle': 'The Effect of Aerobic Exercise on an Elliptical Trainer Versus a Treadmill, in People with Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'The Effect of Aerobic Exercise on an Elliptical Trainer Versus a Treadmill, on Gait and Walking Abilities, Expressed in Dynamic Stability, Balance and Walking Speed, in People with Multiple Sclerosis (MS)', 'orgStudyIdInfo': {'id': '0104-23-SOR'}, 'secondaryIdInfos': [{'id': '0104-23-SOR', 'type': 'OTHER', 'domain': 'Soroka Medical Center, Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 - Elliptical Trainer', 'description': '15 MS subjects will be enrolled and assigned to group 1 and to be trained (Elliptical Trainer) twice a week for 12 weeks.', 'interventionNames': ['Other: Physical Training']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 - Treadmill', 'description': '15 MS subjects will be enrolled and assigned to group 2 and to be trained (Treadmill) twice a week for 12 weeks.', 'interventionNames': ['Other: Physical Training']}], 'interventions': [{'name': 'Physical Training', 'type': 'OTHER', 'description': 'Group 1 - Elliptical Trainer Group 2 - Treadmill', 'armGroupLabels': ['Group 1 - Elliptical Trainer', 'Group 2 - Treadmill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8410101', 'city': 'Beersheba', 'state': 'Israel', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Iuly Treger, MD', 'role': 'CONTACT', 'email': 'iulyt@clalit.org.il', 'phone': '+972-8-6245151'}, {'name': 'Michal Alegranti-Sivan', 'role': 'CONTACT', 'email': 'michal.sivan@gmail.com', 'phone': '+972-54-6393850'}, {'name': 'Shayke Hutzler, PhD', 'role': 'CONTACT'}, {'name': 'Michal Alegranti-Sivan', 'role': 'CONTACT'}], 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '52535', 'city': 'Ramat Gan', 'state': 'Israel', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Michal Alegranti-Sivan', 'role': 'CONTACT', 'email': 'michal.sivan@gmail.com', 'phone': '+972+54-6393850'}, {'name': 'Shayke Hutzler, PhD', 'role': 'CONTACT', 'email': 'shayke.hutzler@gmail.com'}], 'facility': 'Israel ParaSport Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Michal Alegranti Sivan, B.Sc.', 'role': 'CONTACT', 'email': 'michal.sivan@gmail.com', 'phone': '+972-54-639-3850'}], 'overallOfficials': [{'name': 'Iuly Treger, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "There isn't any plan to make IPD available to other researchers."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Head of Rehabilitation Department', 'investigatorFullName': 'Iuly Treger, M.D., PhD, MHA', 'investigatorAffiliation': 'Soroka University Medical Center'}}}}