Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
Study NCT ID:
NCT05954195
Status:
UNKNOWN
Last Update Posted:
2023-07-20
First Post:
2023-07-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of High Intensity Interval Training in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'the studies mask the participants and they randomly divided into 2 groups then the care provider is masked too not to choose specific participant for specific intervention then the outcome assessor is masked to document the outcomes with fair then the investigator is masked too to document results honestly without being motivated towards the intervention.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'high intensity interval training starting by warm up period of 40 % from the HRmax then the interval exercise period of 85-90 % from HRmax ending by cool down period from 30 % of HRmax'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2023-07-12', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive function', 'timeFrame': '8-12 weeks or less', 'description': 'serum levels of serotonin and brain derived necrotic factor (BDNF)'}], 'secondaryOutcomes': [{'measure': 'mental processing speed', 'timeFrame': '8-12 weeks or less', 'description': 'symbol digit modalities test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis AND high intensity interval training'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '28825348', 'type': 'RESULT', 'citation': 'Zimmer P, Bloch W, Schenk A, Oberste M, Riedel S, Kool J, Langdon D, Dalgas U, Kesselring J, Bansi J. High-intensity interval exercise improves cognitive performance and reduces matrix metalloproteinases-2 serum levels in persons with multiple sclerosis: A randomized controlled trial. Mult Scler. 2018 Oct;24(12):1635-1644. doi: 10.1177/1352458517728342. Epub 2017 Aug 21.'}, {'pmid': '33262230', 'type': 'RESULT', 'citation': 'Langeskov-Christensen M, Grondahl Hvid L, Nygaard MKE, Ringgaard S, Jensen HB, Nielsen HH, Petersen T, Stenager E, Eskildsen SF, Dalgas U. Efficacy of High-Intensity Aerobic Exercise on Brain MRI Measures in Multiple Sclerosis. Neurology. 2021 Jan 12;96(2):e203-e213. doi: 10.1212/WNL.0000000000011241. Epub 2020 Dec 1.'}, {'pmid': '35929063', 'type': 'RESULT', 'citation': 'Spaas J, Goulding RP, Keytsman C, Fonteyn L, van Horssen J, Jaspers RT, Eijnde BO, Wust RCI. Altered muscle oxidative phenotype impairs exercise tolerance but does not improve after exercise training in multiple sclerosis. J Cachexia Sarcopenia Muscle. 2022 Oct;13(5):2537-2550. doi: 10.1002/jcsm.13050. Epub 2022 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'In this study, we are aiming to systematically review the literature on the effect of HIIT on MS patients as improving physical performance, cognitive function, aerobic fitness and muscle strength. This could help guide the development of standardized clinical guidelines and direct clinical decision making by the physical therapists whether to implement this type of exercises or not.', 'detailedDescription': 'Multiple sclerosis patients have considerably negative effects on the community and the national and international economy. Chronic symptoms of MS such as fatigue, cognitive impairments, emotional burden and diminished physical functioning considerably affect the daily lives of people with MS and may interfere with social and quality of life factors as friendships, family relationships and occupational status. HIIT has induced significant improvements in physiological conditioning in healthy and clinical populations, and might be appropriate for persons with MS. Recently, several RCTs have been published evaluating the effect of HIIT on MS patients. Consequently, this study will systematically review all these recent literature to direct the physiotherapists whether to implement this type of exercises or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Studies: English full texts of RCTs only, Participants: multiple sclerosis patients with age from (20-50) years old irrespectively of sex, subtype of MS, race, diagnostic criteria, community or onset of the disease, Intervention: HIIT, any comparator.\n\nExclusion Criteria:\n\n* Studies other than English full text RCTs, non adults younger than 20 years and older than 50 years, populations other than multiple sclerosis.'}, 'identificationModule': {'nctId': 'NCT05954195', 'briefTitle': 'Effect of High Intensity Interval Training in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of High Intensity Interval Training in Patients With Multiple Sclerosis: Systematic Review', 'orgStudyIdInfo': {'id': 'HIIT in MS patients'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HIIT group', 'description': 'The group who received high intensity interval training', 'interventionNames': ['Other: high intensity interval training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control/comparator group', 'description': 'control group that might be placebo group, standard care group or no intervention group', 'interventionNames': ['Other: high intensity interval training']}], 'interventions': [{'name': 'high intensity interval training', 'type': 'OTHER', 'otherNames': ['progressive aerobic training', 'sprinting interval exercise'], 'description': 'high intensity interval training through ergometer, with whole treatment session between 20 - 30 minutes divided into 3 parts, the 1st is warming up (40% of HRmax intensity for 2/3/5 minutes then the active training part (intervals of 85-90% of HRmax for 1 minute then rest period of 1 minute of 40 % of HRmax and so on for nearly 20 minutes ) then the last part is cooling down (30 % of HRmax for 3/5 minutes).', 'armGroupLabels': ['HIIT group', 'control/comparator group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34724', 'city': 'Damietta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Fatma Khaled M. Abdelaziz, Master', 'role': 'CONTACT', 'email': 'fabdelaziz@horus.edu.eg', 'phone': '+2001006196295'}], 'facility': 'Azzarqa', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}], 'centralContacts': [{'name': 'Fatma Khaled M. Abdelaziz, master', 'role': 'CONTACT', 'email': 'fabdelaziz@horus.edu.eg', 'phone': '+2001006196295'}, {'name': 'Hossam M. Elsaid, lecturer', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Abeer Abobakr Dr Alwishy, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Physical therapy for neuromuscular disorders and its surgeries, Cairo university'}, {'name': 'Neveen Mohy-Eldin shalaby, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of medicine, Alqasr elainy, Cairo university'}, {'name': 'Hossam M. Elsaid, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of physical therapy of neuromuscloskeletal disorders and its surgeries, Cairo universities'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'a protocol about the effect of high intensity interval training in patients with multiple sclerosis: systematic review'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fatma Khaled Mohamed Abdelaziz', 'investigatorFullName': 'Fatma Khaled Mohamed Abdelaziz', 'investigatorAffiliation': 'Cairo University'}}}}