NCT03189342

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration 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

January 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

June 14, 2017

Last Update Submit

June 15, 2017

Conditions

Keywords

BalanceDual-task interferenceFallsGaitOlder Adults

Outcome Measures

Primary Outcomes (5)

  • 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

  • Gait speed under dual task condition

    The participants walked 10 meter while producing words which started with letter "K"

    4 weeks

  • 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

  • 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

  • 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

Study Arms (3)

Single Task Training

EXPERIMENTAL

Performed balance and gait exercises

Behavioral: Single task training

Dual task training

EXPERIMENTAL

Performed cognitive activity simultaneously with balance and gait exercises

Behavioral: dual task training

Exercise-Cognitive Activity Combined Training

EXPERIMENTAL

Performed cognitive, balance and gait activity training asynchronously at different times during the same day

Behavioral: exercise-cognitive activity combined training

Interventions

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

Single 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

Dual task 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.

Exercise-Cognitive Activity Combined Training

Eligibility Criteria

Age65 Years - 83 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • neurological or musculoskeletal diagnosis such as Parkinson's or Alzheimer's disease,
  • orthopaedic involvement or significant visual and auditory impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol Mega University Hospital

Istanbul, 34214, Turkey (Türkiye)

Location

Related Publications (29)

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

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

    BACKGROUND
  • 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

    BACKGROUND
  • Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. doi: 10.1093/ageing/afl084.

    PMID: 16926202BACKGROUND
  • 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. doi: 10.1111/j.1532-5415.2007.01317.x.

    PMID: 17908062BACKGROUND
  • 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.

    PMID: 20085954BACKGROUND
  • Karlsson MK, Vonschewelov T, Karlsson C, Coster 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.

    PMID: 23554390BACKGROUND
  • 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. doi: 10.1111/j.1532-5415.2007.01413.x. Epub 2007 Oct 3.

    PMID: 17916121BACKGROUND
  • 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. doi: 10.1590/bjpt-rbf.2014.0034. Epub 2014 Sep 12.

    PMID: 25372007BACKGROUND
  • 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. doi: 10.1136/bmj.328.7441.680.

    PMID: 15031239BACKGROUND
  • 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.

    PMID: 25721432BACKGROUND
  • 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.

    PMID: 25377745BACKGROUND
  • Thrane G, Joakimsen RM, Thornquist E. The association between timed up and go test and history of falls: the Tromso study. BMC Geriatr. 2007 Jan 12;7:1. doi: 10.1186/1471-2318-7-1.

    PMID: 17222340BACKGROUND
  • Keskinoğlu 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

    BACKGROUND
  • 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.

    PMID: 16630375BACKGROUND
  • 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.

    PMID: 18194967BACKGROUND
  • 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. doi: 10.1519/00139143-200831010-00006.

    PMID: 18489806BACKGROUND
  • 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.

    PMID: 19254600BACKGROUND
  • 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.

    PMID: 16445340BACKGROUND
  • 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. doi: 10.1093/ptj/77.8.812.

    PMID: 9256869BACKGROUND
  • 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: 10960937BACKGROUND
  • Patil R, Uusi-Rasi K, Kannus P, Karinkanta S, Sievanen 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.

    PMID: 24107382BACKGROUND
  • Halvarsson A, Oddsson L, Olsson E, Faren E, Pettersson A, Stahle 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.

    PMID: 21849377BACKGROUND
  • Halvarsson A, Franzen E, Stahle 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.

    PMID: 25142277BACKGROUND
  • 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. doi: 10.1007/s00426-004-0192-7. Epub 2004 Nov 17.

    PMID: 16703392BACKGROUND
  • 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.

    PMID: 19093923BACKGROUND
  • 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.

    PMID: 25511081BACKGROUND
  • 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. doi: 10.1093/geronb/62.3.p141.

    PMID: 17507581BACKGROUND
  • Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Exercise training The volunteers were assigned to one of three interventions for 4 weeks. Group 1 performed balance and gait exercises. Group 2 performed cognitive activity simultaneously with balance and gait exercises. Group 3 performed cognitive, balance and gait activity training asynchronously at different times during the same day.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 16, 2017

Study Start

January 1, 2015

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

June 16, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

There is no plan to share data for other researches

Locations