Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 5:33 AM
Study NCT ID:
NCT04452760
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2020-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2020-06-26', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Voluntary Isometric Contraction of Knee Extension', 'timeFrame': 'Before the program training', 'description': 'the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.'}, {'measure': 'Maximal Voluntary Isometric Contraction of Knee Extension', 'timeFrame': 'After 10 weeks', 'description': 'the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.'}, {'measure': 'Rate of Force Development', 'timeFrame': 'Before the program training', 'description': 'Rate of force development in knee extension'}, {'measure': 'Rate of Force Development', 'timeFrame': 'After 10 weeks', 'description': 'Rate of force development in knee extension'}, {'measure': 'Central Activation Ratio', 'timeFrame': 'Before the program training', 'description': 'The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions'}, {'measure': 'Central Activation Ratio', 'timeFrame': 'After 10 weeks', 'description': 'The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions'}, {'measure': 'Spasticity', 'timeFrame': 'Before the program training', 'description': 'Pendulum test'}, {'measure': 'Spasticity', 'timeFrame': 'After 10 weeks', 'description': 'Pendulum test'}], 'secondaryOutcomes': [{'measure': 'Walking speed', 'timeFrame': 'Before the program training', 'description': 'Test 10 m-walks'}, {'measure': 'Walking speed', 'timeFrame': 'After 10 weeks', 'description': 'Test 10 m-walks'}, {'measure': 'Static Balance', 'timeFrame': 'Before the program training', 'description': 'Romberg Test with eyes open and closed. Analysis with force plates'}, {'measure': 'Static Balance', 'timeFrame': 'After 10 weeks', 'description': 'Romberg Test with eyes open and closed. Analysis with force plates'}, {'measure': 'Functional capacity', 'timeFrame': 'Before the program training', 'description': 'Sit-to-Stand Test'}, {'measure': 'Functional capacity', 'timeFrame': 'After 10 weeks', 'description': 'Sit-to-Stand Test'}, {'measure': 'Heart Rate Variability', 'timeFrame': 'Before the program training', 'description': 'Sleeping Heart Rate Variability'}, {'measure': 'Heart Rate Variability', 'timeFrame': 'After 10 weeks', 'description': 'Sleeping Heart Rate Variability'}, {'measure': 'Sleep Quality', 'timeFrame': 'Before the program training', 'description': 'Acelerometry and Karolinska Sleep Diary'}, {'measure': 'Sleep Quality', 'timeFrame': 'After 10 weeks', 'description': 'Acelerometry and Karolinska Sleep Diary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neurological disorders', 'resistance training', 'strength training', 'sleep quality', 'neuromuscular performance', 'functional capacity'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '35905806', 'type': 'DERIVED', 'citation': 'Andreu-Caravaca L, Ramos-Campo DJ, Chung LH, Rubio-Arias JA. Can strength training modify voluntary activation, contractile properties and spasticity in Multiple Sclerosis?: A randomized controlled trial. Physiol Behav. 2022 Oct 15;255:113932. doi: 10.1016/j.physbeh.2022.113932. Epub 2022 Jul 27.'}, {'pmid': '34107841', 'type': 'DERIVED', 'citation': 'Andreu-Caravaca L, Ramos-Campo DJ, Abellan-Aynes O, Avila-Gandia V, Chung LH, Manonelles P, Rubio-Arias JA. 10-Weeks of resistance training improves sleep quality and cardiac autonomic control in persons with multiple sclerosis. Disabil Rehabil. 2022 Sep;44(18):5241-5249. doi: 10.1080/09638288.2021.1934738. Epub 2021 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease of the central nervous system, characterized by demyelination due to inflammation and degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter, brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems. Strength training has been shown to improve strength and mobility in persons with MS.', 'detailedDescription': 'Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease of the central nervous system, characterized by demyelination due to inflammation and degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter, brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems. Resistance training has been shown to improve strength, sleep quality and mobility in persons with MS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild or moderate disability with clinical mild spastic-ataxic gait disorder.\n* stable phase of the disease.\n\nExclusion Criteria:\n\n* Expanded Disability Status Scale (EDSS) \\< 6.\n* relapsing disease within the preceding 12 months.\n* corticosteroid treatment within the last months before study inclusion.'}, 'identificationModule': {'nctId': 'NCT04452760', 'briefTitle': 'Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'UCAM-CE071923'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Only testing sessions', 'interventionNames': ['Other: Testing sessions']}, {'type': 'EXPERIMENTAL', 'label': 'Progressive resistance training group', 'description': '10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises.', 'interventionNames': ['Other: Physical exercise', 'Other: Testing sessions']}], 'interventions': [{'name': 'Physical exercise', 'type': 'OTHER', 'description': 'Physical exercise intervention', 'armGroupLabels': ['Progressive resistance training group']}, {'name': 'Testing sessions', 'type': 'OTHER', 'description': 'Testing sessions', 'armGroupLabels': ['Control group', 'Progressive resistance training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30107', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Universidad Católica San Antonio', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'overallOfficials': [{'name': 'Jacobo Á Rubio-Arias, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Politecnica de Madrid'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After the completion of study', 'ipdSharing': 'YES', 'description': 'The data will be published in a journal', 'accessCriteria': 'The data will be published in a journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jacobo Á. Rubio', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}