Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-07 @ 12:48 PM
Study NCT ID:
NCT02541305
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2015-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM IN INSTITUTIONALIZED ELDERLY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Up and Go (TUG) test', 'timeFrame': 'Participants will be followed an expected average of 5 weeks.', 'description': 'Evaluates mobility testing both static balance and the dynamic by measuring the time taken to perform a task.'}], 'secondaryOutcomes': [{'measure': 'Tinnetti scale', 'timeFrame': 'Participants will be followed an expected average of 5 weeks.', 'description': 'It consists of two subscales, gait and balance, where less than 19 points overall results indicate a high risk of falling'}, {'measure': 'Questionnaire risk of falls in hospital (Morse)', 'timeFrame': 'Participants will be followed an expected average of 5 weeks.', 'description': 'This questionnaire has 6 items with a total range of 0-125.'}, {'measure': 'Cooper test', 'timeFrame': 'Participants will be followed an expected average of 5 weeks.', 'description': 'Walking for 12 minutes around cones along the floor.'}, {'measure': 'Support time monopodal', 'timeFrame': 'Participants will be followed an expected average of 5 weeks.', 'description': 'Postural control is valued.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['falls prevention', 'proprioception', 'physical condition'], 'conditions': ['Accidental Falls']}, 'referencesModule': {'references': [{'pmid': '11983637', 'type': 'BACKGROUND', 'citation': 'Mather AS, Rodriguez C, Guthrie MF, McHarg AM, Reid IC, McMurdo ME. Effects of exercise on depressive symptoms in older adults with poorly responsive depressive disorder: randomised controlled trial. Br J Psychiatry. 2002 May;180:411-5. doi: 10.1192/bjp.180.5.411.'}, {'pmid': '11276182', 'type': 'BACKGROUND', 'citation': "Geiger RA, Allen JB, O'Keefe J, Hicks RR. Balance and mobility following stroke: effects of physical therapy interventions with and without biofeedback/forceplate training. Phys Ther. 2001 Apr;81(4):995-1005."}, {'pmid': '19011727', 'type': 'BACKGROUND', 'citation': 'Iwamoto J, Suzuki H, Tanaka K, Kumakubo T, Hirabayashi H, Miyazaki Y, Sato Y, Takeda T, Matsumoto H. Preventative effect of exercise against falls in the elderly: a randomized controlled trial. Osteoporos Int. 2009 Jul;20(7):1233-40. doi: 10.1007/s00198-008-0794-9. Epub 2008 Nov 15.'}, {'pmid': '23209904', 'type': 'BACKGROUND', 'citation': 'Stathokostas L, Little RM, Vandervoort AA, Paterson DH. Flexibility training and functional ability in older adults: a systematic review. J Aging Res. 2012;2012:306818. doi: 10.1155/2012/306818. Epub 2012 Nov 8.'}, {'pmid': '24591821', 'type': 'RESULT', 'citation': 'Hewitt J, Refshauge KM, Goodall S, Henwood T, Clemson L. Does progressive resistance and balance exercise reduce falls in residential aged care? Randomized controlled trial protocol for the SUNBEAM program. Clin Interv Aging. 2014 Feb 21;9:369-76. doi: 10.2147/CIA.S53931. eCollection 2014.'}, {'pmid': '15743297', 'type': 'RESULT', 'citation': 'Jorstad EC, Hauer K, Becker C, Lamb SE; ProFaNE Group. Measuring the psychological outcomes of falling: a systematic review. J Am Geriatr Soc. 2005 Mar;53(3):501-10. doi: 10.1111/j.1532-5415.2005.53172.x.'}, {'pmid': '22071817', 'type': 'RESULT', 'citation': 'Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.'}, {'pmid': '19230765', 'type': 'RESULT', 'citation': 'Sturnieks DL, Finch CF, Close JC, Tiedemann A, Lord SR, Pascoe DA. Exercise for falls prevention in older people: assessing the knowledge of exercise science students. J Sci Med Sport. 2010 Jan;13(1):59-64. doi: 10.1016/j.jsams.2008.11.005. Epub 2009 Feb 20.'}, {'pmid': '18348591', 'type': 'RESULT', 'citation': 'Orr R, Raymond J, Fiatarone Singh M. Efficacy of progressive resistance training on balance performance in older adults : a systematic review of randomized controlled trials. Sports Med. 2008;38(4):317-43. doi: 10.2165/00007256-200838040-00004.'}, {'pmid': '23235623', 'type': 'RESULT', 'citation': 'Cameron ID, Gillespie LD, Robertson MC, Murray GR, Hill KD, Cumming RG, Kerse N. Interventions for preventing falls in older people in care facilities and hospitals. Cochrane Database Syst Rev. 2012 Dec 12;12:CD005465. doi: 10.1002/14651858.CD005465.pub3.'}, {'pmid': '12851185', 'type': 'RESULT', 'citation': 'Barnett A, Smith B, Lord SR, Williams M, Baumand A. Community-based group exercise improves balance and reduces falls in at-risk older people: a randomised controlled trial. Age Ageing. 2003 Jul;32(4):407-14. doi: 10.1093/ageing/32.4.407.'}, {'pmid': '11845750', 'type': 'RESULT', 'citation': "O'Connell B, Myers H. The sensitivity and specificity of the Morse Fall Scale in an acute care setting. J Clin Nurs. 2002 Jan;11(1):134-6. doi: 10.1046/j.1365-2702.2002.00578.x. No abstract available."}, {'pmid': '3953620', 'type': 'RESULT', 'citation': 'Tinetti ME, Williams TF, Mayewski R. Fall risk index for elderly patients based on number of chronic disabilities. Am J Med. 1986 Mar;80(3):429-34. doi: 10.1016/0002-9343(86)90717-5.'}, {'pmid': '10960937', 'type': 'RESULT', 'citation': 'Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.'}, {'pmid': '9180669', 'type': 'RESULT', 'citation': 'Vellas BJ, Wayne SJ, Romero L, Baumgartner RN, Rubenstein LZ, Garry PJ. One-leg balance is an important predictor of injurious falls in older persons. J Am Geriatr Soc. 1997 Jun;45(6):735-8. doi: 10.1111/j.1532-5415.1997.tb01479.x.'}, {'pmid': '23327448', 'type': 'RESULT', 'citation': 'Cadore EL, Rodriguez-Manas L, Sinclair A, Izquierdo M. Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: a systematic review. Rejuvenation Res. 2013 Apr;16(2):105-14. doi: 10.1089/rej.2012.1397.'}, {'pmid': '18557964', 'type': 'RESULT', 'citation': 'Banez C, Tully S, Amaral L, Kwan D, Kung A, Mak K, Moghabghab R, Alibhai SM. Development, implementation, and evaluation of an Interprofessional Falls Prevention Program for older adults. J Am Geriatr Soc. 2008 Aug;56(8):1549-55. doi: 10.1111/j.1532-5415.2008.01790.x. Epub 2008 Jun 28.'}, {'pmid': '22592162', 'type': 'RESULT', 'citation': 'Espejo Antunez L, Cardero Duran MA, Caro Puertolas B, Tellez de Peralta G. [Effects of exercise on the function and quality of life in the institutionalised elderly diagnosed with gonarthrosis]. Rev Esp Geriatr Gerontol. 2012 Nov-Dec;47(6):262-5. doi: 10.1016/j.regg.2011.06.011. Epub 2012 May 14. Spanish.'}, {'pmid': '32663479', 'type': 'DERIVED', 'citation': 'Espejo-Antunez L, Perez-Marmol JM, Cardero-Duran MLA, Toledo-Marhuenda JV, Albornoz-Cabello M. The Effect of Proprioceptive Exercises on Balance and Physical Function in Institutionalized Older Adults: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Oct;101(10):1780-1788. doi: 10.1016/j.apmr.2020.06.010. Epub 2020 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'Knowing the effects of proprioceptive exercise program in improving balance, gait and risk of falls in institutionalized elderly.', 'detailedDescription': 'The aim of this study will be to determine the effects of proprioceptive exercise program in improving balance and gait as well as reducing the risk of falls in institutionalized elderly in a healthcare center. To evaluate this effect, a total of 45 subjects will participate in a longitudinal and controlled trial. Inclusion criteria will be over 65 years olds, be institutionalized in the center and have ability to read and write.\n\nThereafter, participants will be separated into two different groups (experimental and control). Randomization was performed using sealed envelopes with different numbers of intervention inside. Both groups will be evaluated both at the start of the first session and in the last working session.\n\nThe control group performed a geriatric revitalization program as the experimental group. Besides this one, experimental group performed a program of proprioceptive exercises. The intervention rate will 2 weekly sessions for 12 weeks for both groups (24 sessions), lasting 55 minutes. The variables analyzed were: the questionnaire risk of falls in hospital (MORSE), Tinetti scale, the test Timed Up and Go (TUG), the time of one leg and the Cooper test running 12 minutes.\n\nThe data analysis will perform using the Statistical Package for the Social Sciences (SPSS statistical software), version 19.0 for Windows, Chicago.\n\nTo determine the normal distribution of the data the Shapiro-Wilks test and comparison by ANOVA was performed. The values obtained in the pretest and posttest assessment for each variable will be compared by Student t test for related samples or by the Wilcoxon rank test.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being institutionalized,\n* own ability to read and write,\n* and access the study voluntarily.\n\nExclusion Criteria:\n\n* Significant degree of cognitive impairment;\n* intolerance moderate physical activity, caused by cardiovascular or respiratory disease,\n* as well as those who did not complete 90% of the sessions.'}, 'identificationModule': {'nctId': 'NCT02541305', 'briefTitle': 'EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM IN INSTITUTIONALIZED ELDERLY', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Miguel Hernandez de Elche'}, 'officialTitle': 'EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM ON PREDICTORS OF RISK OF FALLS IN INSTITUTIONALIZED ELDERLY', 'orgStudyIdInfo': {'id': 'JVT001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cotrol', 'description': 'No propioceptive program.', 'interventionNames': ['Other: No propioceptive program']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Propioceptive program', 'interventionNames': ['Other: propioceptive program']}], 'interventions': [{'name': 'propioceptive program', 'type': 'OTHER', 'description': 'The training program has 6 specific proprioceptive exercises, each five minutes long, which will conducted in static and dynamic positions for a period of 30 minutes. Each exercise session will include 55 minutes (15 minutes of warm-up with slow walk, mobility and stretching exercise, followed by 30 minutes of a propioceptive exercises program, and finishing with 10 minutes of cool down through stretching and relaxation exercises)', 'armGroupLabels': ['Experimental']}, {'name': 'No propioceptive program', 'type': 'OTHER', 'description': 'The control group continued to perform their daily activities without changing any habit. Geriatric revitalization program without proprioceptive exercises.', 'armGroupLabels': ['Cotrol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06006', 'city': 'Badajoz', 'state': 'Extremadura', 'country': 'Spain', 'facility': 'Socio- Health Center Puente Real ( Health Care for Older © ) of Badajoz', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}], 'overallOfficials': [{'name': 'María Ángeles Cardero-Durán, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Extremadura'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Miguel Hernandez de Elche', 'class': 'OTHER'}, 'collaborators': [{'name': 'Socio- Health Center Puente Real ( Health Care for Older © ) of Badajoz', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'JOSE VICENTE TOLEDO MARHUENDA', 'investigatorAffiliation': 'Universidad Miguel Hernandez de Elche'}}}}