EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM IN INSTITUTIONALIZED ELDERLY

Accidental Falls Clinical Trial

Official title:

EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM ON PREDICTORS OF RISK OF FALLS IN INSTITUTIONALIZED ELDERLY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541305
• Other study ID #: JVT001
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2023
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Thereafter, 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.

The 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.

The data analysis will perform using the Statistical Package for the Social Sciences (SPSS statistical software), version 19.0 for Windows, Chicago.

To 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Being institutionalized,

• own ability to read and write,

• and access the study voluntarily.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Other:
• propioceptive program
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)
• No propioceptive program
The control group continued to perform their daily activities without changing any habit. Geriatric revitalization program without proprioceptive exercises.

Locations

Country	Name	City	State
Spain	Socio- Health Center Puente Real ( Health Care for Older © ) of Badajoz	Badajoz	Extremadura

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Socio- Health Center Puente Real ( Health Care for Older © ) of Badajoz

Country where clinical trial is conducted

Spain, 

References & Publications (18)

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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. — View 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 — View Citation

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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. — View Citation

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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 — View 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;(11):CD004963. doi: 10.1002/14651858.CD004963.pub3. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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 — View 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. — View 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tinnetti scale	It consists of two subscales, gait and balance, where less than 19 points overall results indicate a high risk of falling	Participants will be followed an expected average of 5 weeks.
Secondary	Questionnaire risk of falls in hospital (Morse)	This questionnaire has 6 items with a total range of 0-125.	Participants will be followed an expected average of 5 weeks.
Secondary	Cooper test	Walking for 12 minutes around cones along the floor.	Participants will be followed an expected average of 5 weeks.
Secondary	Support time monopodal	Postural control is valued.	Participants will be followed an expected average of 5 weeks.