- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03189342
Effects of Training on Fall Risk and Balance Performances
June 15, 2017 updated by: leyla atas balci, Istanbul Medipol University Hospital
Effects of Dual-Task Training and Exercise-Cognitive Activity Combined Training on Fall Risk and Balance Performance in Elderly at Risk of Falls: A Randomised Controlled Trial Study
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34214
- Medipol Mega University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 83 years (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single Task Training
Performed balance and gait exercises
|
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
|
EXPERIMENTAL: Dual task training
Performed cognitive activity simultaneously with balance and gait exercises
|
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
|
EXPERIMENTAL: Exercise-Cognitive Activity Combined Training
Performed cognitive, balance and gait activity training asynchronously at different times during the same day
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait speed under single task condition
Time Frame: 4 weeks
|
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
Time Frame: 4 weeks
|
The participants walked 10 meter while producing words which started with letter "K"
|
4 weeks
|
Timed Up and Go test
Time Frame: 4 weeks
|
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
Time Frame: 4 weeks
|
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
Time Frame: 4 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- WHO Global Report on Falls Prevention in Older Age. 2007. Geneva, Switzerland: World Health Organization
- Falls, Fact sheet N°344. October 2012. World Health Organization
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Clin Rehabil. 2012 Nov;26(11):1055. Oddsson, Lars [added].
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2015
Primary Completion (ACTUAL)
October 1, 2016
Study Completion (ACTUAL)
November 1, 2016
Study Registration Dates
First Submitted
June 14, 2017
First Submitted That Met QC Criteria
June 15, 2017
First Posted (ACTUAL)
June 16, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 16, 2017
Last Update Submitted That Met QC Criteria
June 15, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E.4629
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share data for other researches
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Accidental Falls
-
The Hospital District of SatakuntaCompleted
-
University Hospital, Basel, SwitzerlandCompletedAccidental Falls | Underlying Disease of FallsSwitzerland, Germany
-
Shirley HuangJintronixRecruiting
-
Sigma Theta Tau InternationalRecruiting
-
University of Maryland, BaltimoreVA Maryland Health Care SystemRecruitingAccidental FallsUnited States
-
Universidad Miguel Hernandez de ElcheSocio- Health Center Puente Real ( Health Care for Older © ) of BadajozCompleted
-
The Hong Kong Polytechnic UniversityCompletedAccidental FallsHong Kong
-
Montana State UniversityCompletedAccidental FallsUnited States
-
University of PittsburghBoston University; Foundation for Physical Therapy, Inc.; Mt. Ascutney Hospital...CompletedAccidental FallsUnited States
-
Duke UniversityNational Institute of Nursing Research (NINR); The Carolinas Center for Medical...CompletedAccidental FallsUnited States
Clinical Trials on Single task training
-
Eastern Mediterranean UniversityCompletedMild Cognitive ImpairmentCyprus
-
Igdir UniversityNot yet recruiting
-
Gazi UniversityCompleted
-
Tan Tock Seng HospitalNational Neuroscience Institute; Nanyang PolytechnicRecruitingMild Cognitive ImpairmentSingapore
-
The University of Hong KongUnknownFall | Balance | Reinvestment Propensity | Gait RehabilitationHong Kong
-
Ufuk UniversityCompletedBalance Impairment
-
The Queen Elizabeth HospitalThe Hong Kong Polytechnic UniversityUnknown
-
The Hong Kong Polytechnic UniversityResearch Grants Council, Hong KongRecruiting
-
Chang Gung UniversityMackay Memorial HospitalCompleted