Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-03-14 @ 10:14 PM
Study NCT ID:
NCT01086592
Status:
COMPLETED
Last Update Posted:
2010-07-05
First Post:
2010-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Program of Physical Exercise and Electrotherapy on Muscle Strength in Subjects of the Fourth Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-02', 'studyFirstSubmitDate': '2010-03-09', 'studyFirstSubmitQcDate': '2010-03-12', 'lastUpdatePostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Capacity', 'timeFrame': '3 months', 'description': "Berg's Scale, SF-36 test, 6 minute walking test, Barthel test, SPPB."}], 'secondaryOutcomes': [{'measure': 'Strength in lower limbs', 'timeFrame': '3 months', 'description': 'Dinamometry, bioimpedancy.'}, {'measure': 'Timed standing balance. Side by side, semi tandem, tandem stand and one-leg stand', 'timeFrame': '3 months', 'description': 'Berg Scale, SPPB.'}, {'measure': 'Maximum Gait Speed. Time to cover a 4 meter distance', 'timeFrame': '3 months', 'description': 'Physical performance test'}, {'measure': 'Body mass index', 'timeFrame': '3 months', 'description': 'Bioimpedancy, ecography, lower limb perimeter.'}, {'measure': 'Six-minute walking test', 'timeFrame': '3 months', 'description': 'Physical performance test, assessing maximum distance covered during 6 minutes (assistance allowed if required).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aged', 'Strength', 'Balance', 'Electrotherapy', 'Quality of life'], 'conditions': ['Geriatric Assessment', 'Muscle Strength', 'Postural Balance', 'Body Mass Index']}, 'referencesModule': {'references': [{'pmid': '15304540', 'type': 'BACKGROUND', 'citation': 'Barry BK, Carson RG. The consequences of resistance training for movement control in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):730-54. doi: 10.1093/gerona/59.7.m730.'}, {'pmid': '15730336', 'type': 'BACKGROUND', 'citation': 'Bax L, Staes F, Verhagen A. Does neuromuscular electrical stimulation strengthen the quadriceps femoris? A systematic review of randomised controlled trials. Sports Med. 2005;35(3):191-212. doi: 10.2165/00007256-200535030-00002.'}, {'pmid': '8081406', 'type': 'BACKGROUND', 'citation': 'Caggiano E, Emrey T, Shirley S, Craik RL. Effects of electrical stimulation or voluntary contraction for strengthening the quadriceps femoris muscles in an aged male population. J Orthop Sports Phys Ther. 1994 Jul;20(1):22-8. doi: 10.2519/jospt.1994.20.1.22.'}, {'pmid': '15107011', 'type': 'BACKGROUND', 'citation': 'Hunter GR, McCarthy JP, Bamman MM. Effects of resistance training on older adults. Sports Med. 2004;34(5):329-48. doi: 10.2165/00007256-200434050-00005.'}, {'pmid': '16271009', 'type': 'BACKGROUND', 'citation': 'Paillard T, Noe F, Passelergue P, Dupui P. Electrical stimulation superimposed onto voluntary muscular contraction. Sports Med. 2005;35(11):951-66. doi: 10.2165/00007256-200535110-00003.'}, {'pmid': '25131453', 'type': 'DERIVED', 'citation': 'Benavent-Caballer V, Rosado-Calatayud P, Segura-Orti E, Amer-Cuenca JJ, Lison JF. Effects of three different low-intensity exercise interventions on physical performance, muscle CSA and activities of daily living: a randomized controlled trial. Exp Gerontol. 2014 Oct;58:159-65. doi: 10.1016/j.exger.2014.08.004. Epub 2014 Aug 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether neuromuscular electrical stimulation, strengthening exercises, or combination of both over lower limbs are effective in the improvement of the stability fundamentally against falls, greater independence and, therefore, better quality of life in elderly over 75 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 75\n\nExclusion Criteria:\n\n* Mental disorder\n* Previous electrotherapy treatments\n* Pacemakers\n* Lower limbs prosthetics\n* Major coronary diseases'}, 'identificationModule': {'nctId': 'NCT01086592', 'briefTitle': 'Effects of a Program of Physical Exercise and Electrotherapy on Muscle Strength in Subjects of the Fourth Age', 'organization': {'class': 'OTHER', 'fullName': 'Cardenal Herrera University'}, 'officialTitle': 'Effects of a Program of Physical Exercise and Electrotherapy on Muscle Strength in Subjects of the Fourth Age', 'orgStudyIdInfo': {'id': 'CEU-UCH-87'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: No intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Strengthening exercise', 'description': 'Strong progressive strengthening exercises of lower limbs.', 'interventionNames': ['Other: Strong progressive strengthening exercises of lower limbs']}, {'type': 'EXPERIMENTAL', 'label': 'Electrotherapy', 'description': 'Neuromuscular Electrical Nerve Stimulation', 'interventionNames': ['Other: Electrotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Electrotherapy+weights', 'interventionNames': ['Other: Electrotherapy+weights']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Daily life activities', 'armGroupLabels': ['Control']}, {'name': 'Strong progressive strengthening exercises of lower limbs', 'type': 'OTHER', 'description': 'Lower limb weight', 'armGroupLabels': ['Strengthening exercise']}, {'name': 'Electrotherapy', 'type': 'OTHER', 'description': 'Neuromuscular Electrical Nerve Stimulation', 'armGroupLabels': ['Electrotherapy']}, {'name': 'Electrotherapy+weights', 'type': 'OTHER', 'description': 'Superimposed Neuromuscular Electric Nerve Stimulation', 'armGroupLabels': ['Electrotherapy+weights']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46113', 'city': 'Moncada', 'state': 'Valencia', 'country': 'Spain', 'facility': 'CEU-Cardenal Herrera University', 'geoPoint': {'lat': 39.54555, 'lon': -0.39551}}], 'overallOfficials': [{'name': 'Javier Romero, Dean', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Facultad Ciencias Salud CEU-UCH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardenal Herrera University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pedro Rosado Calatayud/Physical Therapy Coordinator', 'oldOrganization': 'CEU-Cardenal Herrera'}}}}