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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03189342
Other study ID # E.4629
Secondary ID
Status Completed
Phase N/A
First received June 14, 2017
Last updated June 15, 2017
Start date January 2015
Est. completion date November 2016

Study information

Verified date June 2017
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dual task training has been shown to reduce the risk of falls more than single task training. However, there have been no studies which compared the effects of single task training, dual task training and asynchronous cognitive, balance exercise training during same day on the risk of falls among healthy older individuals. Therefore, the aim of this study was to investigate differences among the effects of single task training, dual task training and exercise-cognitive activity combined training on balance and gait performances and fall risk in elderly at risk of fall.


Description:

The term "dual task" refers to the ability of performing 2 tasks simultaneously, for example, a cognitive and a motor task. Previous studies demonstrated that dual task training is more effective than single task training in reducing falls among elderly. These studies demonstrated that the improvements in balance and gait speed resulted in a decrease of fall frequency. Although dual task training has been shown to reduce the risk of falls more than single task training, to date, there have been no studies which compared the effects of single task training, dual task training and asynchronous cognitive, balance exercise training during same day on the risk of falls among healthy older individuals. Therefore, the aim of this study was to investigate differences among the effects of single task training, dual task training and exercise-cognitive activity combined training on balance and gait performances and fall risk in elderly at risk of fall.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date November 2016
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 83 Years
Eligibility Inclusion Criteria:

- Age 65 years or older

- literate

- having a fall incident during the past year

- ability to walk 10 meter without any support

- getting more than 13.5 seconds at Timed up and Go test

- getting less than 24 points at Standardized Mini-Mental State Examination

Exclusion Criteria:

- neurological or musculoskeletal diagnosis such as Parkinson's or Alzheimer's disease,

- orthopaedic involvement or significant visual and auditory impairments

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Single task training
The participants in single task training received 30 minutes single task balance and gait exercises, 3 times a week for 4 weeks. The program included static and dynamic balance exercises. Static balance exercises involved body stability (e.g., standing legs open and closed, standing with eyes closed, tandem standing, standing on foam surface and one leg standing, standing while throwing and catching a ball ), forward and backward weight shifting and keeping standing position while being disturbed by external perturbation. Dynamic balance exercises included tandem walking, walking to different direction (backward, side to side), transfer activities (from 1 chair to another) and sit to stand 5 times
dual task training
The participants practiced 30 minutes balance and gait exercises while simultaneously performing cognitive tasks. The program included static and dynamic balance exercises. Static balance exercises involved body stability, forward and backward weight shifting and keeping standing position while being disturbed by external perturbation. Dynamic balance exercises included tandem walking, walking to different direction, transfer activities and sit to stand 5 times. The participants practiced cognitive tasks while simultaneously performing balance and gait exercises. The cognitive tasks included visual attention, auditory attention, planning, verbal fluency, simple mental math and maze activities. At each week, participants performed different type of activities which were designed to foster the executive functions: (1) Visual and auditory attention, (2) Planning and verbal fluency, (3) Simple math problems (4) Visual and auditory attention, planning, verbal fluency, math problems
exercise-cognitive activity combined training
The participants first practiced 30 min of cognitive activities then performed 30 min of balance and gait exercises after 5 min of resting.The program included static and dynamic balance exercises. Static balance exercises involved body stability, forward and backward weight shifting and keeping standing position while being disturbed by external perturbation. Dynamic balance exercises included tandem walking, walking to different direction, transfer activities and sit to stand 5 times. The cognitive tasks included visual attention, auditory attention, planning, verbal fluency, simple mental math and maze activities. At each week, participants performed different type of activities which were designed to foster the executive functions: (1) Visual and auditory attention, (2) Planning and verbal fluency, (3) Simple math problems (4) Visual and auditory attention, planning, verbal fluency, math problems.

Locations

Country Name City State
Turkey Medipol Mega University Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (28)

Austin N, Devine A, Dick I, Prince R, Bruce D. Fear of falling in older women: a longitudinal study of incidence, persistence, and predictors. J Am Geriatr Soc. 2007 Oct;55(10):1598-603. — View Citation

Chang JT, Morton SC, Rubenstein LZ, Mojica WA, Maglione M, Suttorp MJ, Roth EA, Shekelle PG. Interventions for the prevention of falls in older adults: systematic review and meta-analysis of randomised clinical trials. BMJ. 2004 Mar 20;328(7441):680. Review. — View Citation

Falls, Fact sheet N°344. October 2012. World Health Organization

Guedes RC, Dias RC, Pereira LS, Silva SL, Lustosa LP, Dias JM. Influence of dual task and frailty on gait parameters of older community-dwelling individuals. Braz J Phys Ther. 2014 Sep-Oct;18(5):445-52. Epub 2014 Sep 12. — View Citation

Halvarsson A, Franzén E, Ståhle A. Balance training with multi-task exercises improves fall-related self-efficacy, gait, balance performance and physical function in older adults with osteoporosis: a randomized controlled trial. Clin Rehabil. 2015 Apr;29(4):365-75. doi: 10.1177/0269215514544983. Epub 2014 Aug 20. — View Citation

Halvarsson A, Oddsson L, Olsson E, Farén E, Pettersson A, Ståhle A. Effects of new, individually adjusted, progressive balance group training for elderly people with fear of falling and tend to fall: a randomized controlled trial. Clin Rehabil. 2011 Nov;25(11):1021-31. doi: 10.1177/0269215511411937. Epub 2011 Aug 17. Erratum in: Clin Rehabil. 2012 Nov;26(11):1055. Oddsson, Lars [added]. — View Citation

Hardy SE, Perera S, Roumani YF, Chandler JM, Studenski SA. Improvement in usual gait speed predicts better survival in older adults. J Am Geriatr Soc. 2007 Nov;55(11):1727-34. Epub 2007 Oct 3. — View Citation

Karlsson MK, Vonschewelov T, Karlsson C, Cöster M, Rosengen BE. Prevention of falls in the elderly: a review. Scand J Public Health. 2013 Jul;41(5):442-54. doi: 10.1177/1403494813483215. Epub 2013 Apr 3. Review. — View Citation

Keskinoglu P, Uçku R and Yener G. Pretest Results of the Revised Standardized Mini Mental Examination Test in Community Dwelling Elderly. Journal of Neurological Sciences 2008; 25: 18-24

Patil R, Uusi-Rasi K, Kannus P, Karinkanta S, Sievänen H. Concern about falling in older women with a history of falls: associations with health, functional ability, physical activity and quality of life. Gerontology. 2014;60(1):22-30. doi: 10.1159/000354335. Epub 2013 Oct 8. — View Citation

Plummer P, Zukowski LA, Giuliani C, Hall AM, Zurakowski D. Effects of Physical Exercise Interventions on Gait-Related Dual-Task Interference in Older Adults: A Systematic Review and Meta-Analysis. Gerontology. 2015;62(1):94-117. doi: 10.1159/000371577. Epub 2015 Feb 19. Review. — View Citation

Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. Review. — View Citation

Ruthruff E, Van Selst M, Johnston JC, Remington R. How does practice reduce dual-task interference: integration, automatization, or just stage-shortening? Psychol Res. 2006 Mar;70(2):125-42. Epub 2004 Nov 17. — View Citation

Sahin F, Yilmaz F, Ozmaden A, Kotevolu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Berg Balance Scale. J Geriatr Phys Ther. 2008;31(1):32-7. — View Citation

Scheffer AC, Schuurmans MJ, van Dijk N, van der Hooft T, de Rooij SE. Fear of falling: measurement strategy, prevalence, risk factors and consequences among older persons. Age Ageing. 2008 Jan;37(1):19-24. doi: 10.1093/ageing/afm169. Review. — View Citation

Sherrington C, Whitney JC, Lord SR, Herbert RD, Cumming RG, Close JC. Effective exercise for the prevention of falls: a systematic review and meta-analysis. J Am Geriatr Soc. 2008 Dec;56(12):2234-43. doi: 10.1111/j.1532-5415.2008.02014.x. Review. — View Citation

Shubert TE, Schrodt LA, Mercer VS, Busby-Whitehead J, Giuliani CA. Are scores on balance screening tests associated with mobility in older adults? J Geriatr Phys Ther. 2006;29(1):35-9. — View Citation

Shumway-Cook A, Baldwin M, Polissar NL, Gruber W. Predicting the probability for falls in community-dwelling older adults. Phys Ther. 1997 Aug;77(8):812-9. — 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

Silsupadol P, Shumway-Cook A, Lugade V, van Donkelaar P, Chou LS, Mayr U, Woollacott MH. Effects of single-task versus dual-task training on balance performance in older adults: a double-blind, randomized controlled trial. Arch Phys Med Rehabil. 2009 Mar;90(3):381-7. doi: 10.1016/j.apmr.2008.09.559. — View Citation

Silsupadol P, Siu KC, Shumway-Cook A, Woollacott MH. Training of balance under single- and dual-task conditions in older adults with balance impairment. Phys Ther. 2006 Feb;86(2):269-81. — View Citation

Thrane G, Joakimsen RM, Thornquist E. The association between timed up and go test and history of falls: the Tromsø study. BMC Geriatr. 2007 Jan 12;7:1. — View Citation

Tinetti ME, Kumar C. The patient who falls: "It's always a trade-off". JAMA. 2010 Jan 20;303(3):258-66. doi: 10.1001/jama.2009.2024. — View Citation

van het Reve E, de Bruin ED. Strength-balance supplemented with computerized cognitive training to improve dual task gait and divided attention in older adults: a multicenter randomized-controlled trial. BMC Geriatr. 2014 Dec 15;14:134. doi: 10.1186/1471-2318-14-134. — View Citation

Voelcker-Rehage C, Alberts JL. Effect of motor practice on dual-task performance in older adults. J Gerontol B Psychol Sci Soc Sci. 2007 May;62(3):P141-8. — View Citation

Wang X, Pi Y, Chen P, Liu Y, Wang R, Chan C. Cognitive motor interference for preventing falls in older adults: a systematic review and meta-analysis of randomised controlled trials. Age Ageing. 2015 Mar;44(2):205-12. doi: 10.1093/ageing/afu175. Epub 2014 Nov 5. Review. — View Citation

What are the main risk factors for falls amongst older people and what are the most effective interventions to prevent these falls. 2004. Geneva, Switzerland: World Health Organization

WHO Global Report on Falls Prevention in Older Age. 2007. Geneva, Switzerland: World Health Organization

* Note: There are 28 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Gait speed under single task condition The participants walked 10 meter at their comfortable speed and the time to complete the task was recorded 4 weeks
Primary Gait speed under dual task condition The participants walked 10 meter while producing words which started with letter "K" 4 weeks
Primary Timed Up and Go test Timed Up and Go Test is a simple test used to measure mobility. The time required to stand up from a chair, walk 3 m to the line on the floor at a normal pace, walk back to the chair and sit down is measured (Thrane et al 2007) 4 weeks
Primary Berg Balance Scale The Berg Balance Scale (BBS) consists of 14 simple balance related tasks that measure the static, dynamic, and functional balance skills (Sahin et al 2008) 4 weeks
Primary Falls Efficacy Scale Tinetti's Falls Efficacy Scale (FES), which was used to assess fall-related self-efficacy, is a 10-questions scale (Scheffer et al 2008). 4 weeks
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