Accidental FallsNCT03189342
Effects of Training on Fall Risk and Balance Performances
A study testing Single task training, dual task training and exercise-cognitive activity combined training in people with Accidental Falls, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 65 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Single task training, dual task training and exercise-cognitive activity combined training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 83 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- neurological or musculoskeletal diagnosis such as Parkinson's or Alzheimer's disease,
- orthopaedic involvement or significant visual and auditory impairments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol Mega University Hospital
Istanbul, 34214
About this study
Official title: 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.
Read the 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.
- Conditions
- Accidental Falls
- Being tested
- Single task training, dual task training, exercise-cognitive activity combined training
- Keywords
- Balance, Dual-task interference, Falls, Gait, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single task trainingBehavioural
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 trainingBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Task Training | Experimental | Performed balance and gait exercises Receives: Behavioral: Single task training |
| Dual task training | Experimental | Performed cognitive activity simultaneously with balance and gait exercises Receives: 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 Receives: Behavioral: exercise-cognitive activity combined training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed under single task condition
The participants walked 10 meter at their comfortable speed and the time to complete the task was recorded
Measured: 4 weeks
Gait speed under dual task condition
The participants walked 10 meter while producing words which started with letter "K"
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study startJan 2015
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, leyla atas balci, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189342
- Sponsor's protocol ID
- E.4629
- Status last verified
- Jun 2017
- First submitted
- 14 Jun 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share data for other researches
Publications
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.
PubMed 16926202Austin 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.
PubMed 17908062Tinetti 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.
PubMed 20085954Karlsson 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.
PubMed 23554390Hardy 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.
PubMed 17916121Guedes 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.
PubMed 25372007Chang 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.
PubMed 15031239Plummer 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.
PubMed 25721432Wang 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.
PubMed 25377745Thrane 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.
PubMed 17222340Keskinoğlu 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.
PubMed 16630375
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03189342
- Acronym / sponsor ID
- E.4629
- Conditions
- Accidental Falls
- Keywords
- Balance, Dual-task interference, Falls, Gait, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Task Training | Experimental | Behavioral: Single task trainingPerformed balance and gait exercises |
| Dual task training | Experimental | Behavioral: dual task trainingPerformed cognitive activity simultaneously with balance and gait exercises |
| Exercise-Cognitive Activity Combined Training | Experimental | Behavioral: exercise-cognitive activity combined trainingPerformed cognitive, balance and gait activity training asynchronously at different times during the same day |
Who may qualify
- Ages
- 65 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- neurological or musculoskeletal diagnosis such as Parkinson's or Alzheimer's disease,
- orthopaedic involvement or significant visual and auditory impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single task trainingThe 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 | Behavioural | Single Task Training |
| dual task trainingThe 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 | Behavioural | Dual task training |
| exercise-cognitive activity combined trainingThe 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. | Behavioural | Exercise-Cognitive Activity Combined Training |
Primary outcome
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
Gait speed under dual task condition
Time frame: 4 weeks
The participants walked 10 meter while producing words which started with letter "K"
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)
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)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- BackgroundWHO Global Report on Falls Prevention in Older Age. 2007. Geneva, Switzerland: World Health Organization
- BackgroundFalls, Fact sheet N°344. October 2012. World Health Organization
- BackgroundWhat 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: PubMed 16926202Rubenstein 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.
- Background: PubMed 17908062Austin 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.
- Background: PubMed 20085954Tinetti 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.
- Background: PubMed 23554390Karlsson 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.
- Background: PubMed 17916121Hardy 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.
- Background: PubMed 25372007Guedes 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.
- Background: PubMed 15031239Chang 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.
- Background: PubMed 25721432Plummer 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.
- Background: PubMed 25377745Wang 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.
- Individual participant dataSharing planned: No. There is no plan to share data for other researches
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single task training, dual task training and exercise-cognitive activity combined training in people with Accidental Falls, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed under single task condition (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03189342, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.