NCT02541305

Brief Summary

Knowing the effects of proprioceptive exercise program in improving balance, gait and risk of falls in institutionalized elderly.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

July 31, 2015

Last Update Submit

July 18, 2023

Conditions

Accidental Falls

Keywords

falls preventionproprioceptionphysical condition

Outcome Measures

Primary Outcomes (1)

  • Time Up and Go (TUG) test

    Evaluates mobility testing both static balance and the dynamic by measuring the time taken to perform a task.

    Participants will be followed an expected average of 5 weeks.

Secondary Outcomes (4)

  • Tinnetti scale

    Participants will be followed an expected average of 5 weeks.

  • Questionnaire risk of falls in hospital (Morse)

    Participants will be followed an expected average of 5 weeks.

  • Cooper test

    Participants will be followed an expected average of 5 weeks.

  • Support time monopodal

    Participants will be followed an expected average of 5 weeks.

Study Arms (2)

Cotrol

ACTIVE COMPARATOR

No propioceptive program.

Other: No propioceptive program

Experimental

EXPERIMENTAL

Propioceptive program

Other: propioceptive program

Interventions

propioceptive programOTHER

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)

Experimental
No propioceptive programOTHER

The control group continued to perform their daily activities without changing any habit. Geriatric revitalization program without proprioceptive exercises.

Cotrol

Eligibility Criteria

Age65 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being institutionalized,
  • own ability to read and write,
  • and access the study voluntarily.

You may not qualify if:

  • Significant degree of cognitive impairment;
  • intolerance moderate physical activity, caused by cardiovascular or respiratory disease,
  • as well as those who did not complete 90% of the sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Socio- Health Center Puente Real ( Health Care for Older © ) of Badajoz

Badajoz, Extremadura, 06006, Spain

Location

Related Publications (19)

  • 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: 11983637BACKGROUND

  • 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: 11276182BACKGROUND

  • 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: 19011727BACKGROUND

  • 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: 23209904BACKGROUND

  • 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: 24591821RESULT

  • 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: 15743297RESULT

  • 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: 22071817RESULT

  • 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: 19230765RESULT

  • 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: 18348591RESULT

  • 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: 23235623RESULT

  • 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: 12851185RESULT

  • 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: 11845750RESULT

  • 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: 3953620RESULT

  • 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: 10960937RESULT

  • 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: 9180669RESULT

  • 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: 23327448RESULT

  • 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: 18557964RESULT

  • 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: 22592162RESULT

  • 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.

    PMID: 32663479DERIVED

Study Officials

  • María Ángeles Cardero-Durán, PhD

    University of Extremadura

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 31, 2015

First Posted

September 4, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)