AgingNCT03777111
Effect of Single and Dual Task Training on Gait, Balance and Functional Mobility
A study testing Exercise in people with Aging, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Most of the daily life activities include dual task performance. Unlike conventional physiotherapy approaches, dual task training aims to improve both motor performance and cognitive performance at the same time. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2018to 13 Jan 2021
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least to graduate from primary school or ability to read and write
- Mini mental test score> 24
- Ability to achieve daily living activities independently
- Ability to walk independently in the community (at least 10 meters without walking aids)
Who cannot join
- Presence of acute (fracture, surgery), chronic (Parkinson's diseases, diabetes or stroke) and cognitive (Alzheimer, dementia, etc.) diseases
- Presence of hearing impairment that cannot be resolved by hearing devices and presence visual impairment that cannot be resolved by hearing aids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Single and Double Task Training on Gait, Balance and Functional Mobility in the Elderly: Randomized Controlled Study
Most of the daily life activities include dual task performance. Unlike conventional physiotherapy approaches, dual task training aims to improve both motor performance and cognitive performance at the same time. Geriatric rehabilitation approaches in Turkey; single task training (containing only motor performance) is applied to older adults for walking and balance disorders. Recent studies have shown gait parameters and balance abilities are influenced cognitive function and also dual task training is had to include in rehabilitation programs in order to improve walking and balance skills of the healthy elderly. In Turkey, a similar study is not found. The goal of this study is to evaluate in healthy elderly, effect of dual-task and single-task training on gait performance, and their effect on the balance abilities and functional mobility also to evaluate advantages one to another and to gain a different perspective to geriatric rehabilitation for the elderly in Turkey.
Read the detailed description
Protocol:
In this study, the demographic information (age, gender, body mass index, education level, occupation, etc.) of all participants will be recorded first. In the first evaluation, the participants' gait parameters will be determined by using the 10-meter walking test and the wearable sensors. Balance is evaluated by Functional Reach Test, One Leg Stand Test and Tinetti Balance and Gait Assessment. Cognitive skills will be evaluated by using Mini Mental Test and Stroop Test. After the first evaluations of the participants, the participants will be given single or dual task training for 6 weeks, 2 times a week, not on consecutive days. If participants are absent for any training session, a compensation training session will be organized for them. After completing the single and / or dual task training, the final evaluations will be made. Randomization will be performed according to age, gender and body mass index of participants. After the randomization, participants' training group will be determined. Warm-up and cooling exercises will be carried out between 5-10 minutes before and after each training. Each training will consist of approximately 45-60 minutes including warm-up and cooling exercise periods. Each exercise starts with 5 repetitions and proceeds to 10 repetitions. To reduce the effects of fatigue and to draw attention, a break time that consists of approximately 1-2 minutes will be given.
Statistical Analysis:
The effect size obtained in the reference study was strong (d = 1.16). As a result of the power analysis using the effect size value in the reference study for the study, it was calculated that 80% power could be obtained at 95% confidence level when at least 20 people (10 people per group) were included the study. The data will be analyzed with Statistical Package for the Social Sciences (SPSS) package program. Continuous variables will be given as mean ± standard deviation and categorical variables as number and percentage. In the independent group comparisons, if the parametrical test assumptions are obtained, independent samples t-test will be used if the parametric test assumptions are not obtained Mann Whitney U test will be used. In the dependent group comparisons, when the parametric test assumptions are obtained, paired samples t-test; if not obtained Wilcoxon tests will be used.
- Conditions
- Aging
- Being tested
- Exercise
- Keywords
- Aging, gait, balance, functional mobility, dual task training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Single Task Training: Single task training includes exercises that require only one task or stimulation. For this study the task consists of motor tasks (walking or balance) Dual Task Training: Dual task training includes exercises simultaneous performance of two tasks that can be performed independently, measured separately and with different goals. In the study motor tasks will combine with cognitive tasks.
| Study group | Role | What they receive |
|---|---|---|
| Single Task Training Group | Active comparator | Gait and balance exercises will be applied in single task training group.
* Semi-tandem, tandem stand with eyes open and close
* One leg stance with eyes open and close
* Gait exercises; walking forwards, backwards, sidewards, semi-tandem and tandem walking
* Reaching forward and sidewards with eyes open and close Receives: Other: Exercise |
| Dual Task Training Group | Experimental | The exercises given in the single task training group will be combined with the cognitive tasks.
* Semi-tandem, tandem stand with recall a sequence of numbers
* One leg stance with writing pre-defined letters or words with other foot
* Semi-tandem or tandem walking with saying previous number (one or two previous) from number that researcher has given before
* Walking sidewards with collecting numbers that researcher has given
* Walking backwards with counting forward by one (then two or three)
* Reaching forward with counting backward one (then two or three)
* Reaching sidewards with saying next number (one or two next) from number that researcher has given before Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meter walk test
This test will perform with wearable gait sensors and will evaluate gait parameters.
Measured: six week
Functional Reach Test
Balance test
Measured: six week
One Leg stand Test
Balance test
Measured: six week
Tinetti balance and gait assessment
For evaluating balance and gait
Measured: six week
Stroop test
cognitive test
Measured: six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start11 Dec 2018
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel TAŞVURAN HORATA, Pamukkale University
- Investigators
- Suat EREL, Study director, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777111
- Sponsor's protocol ID
- 60116787-020/53283
- Status last verified
- Jan 2021
- First submitted
- 12 Dec 2018
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shin SS, An DH. The Effect of Motor Dual-task Balance Training on Balance and Gait of Elderly Women. J Phys Ther Sci. 2014 Mar;26(3):359-61. doi: 10.1589/jpts.26.359. Epub 2014 Mar 25.
PubMed 24707083Brustio PR, Rabaglietti E, Formica S, Liubicich ME. Dual-task training in older adults: The effect of additional motor tasks on mobility performance. Arch Gerontol Geriatr. 2018 Mar-Apr;75:119-124. doi: 10.1016/j.archger.2017.12.003. Epub 2017 Dec 10.
PubMed 29245071Tasvuran Horata E, Cetin SY, Erel S. Effects of individual progressive single- and dual-task training on gait and cognition among older healthy adults: a randomized-controlled comparison study. Eur Geriatr Med. 2021 Apr;12(2):363-370. doi: 10.1007/s41999-020-00429-5. Epub 2020 Nov 23.
PubMed 33226605
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single and Double Task Training on Gait, Balance and Functional Mobility in the Elderly: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03777111
- Acronym / sponsor ID
- 60116787-020/53283
- Conditions
- Aging
- Keywords
- Aging, gait, balance, functional mobility, dual task training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 17 Dec 2018 (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.
Most of the daily life activities include dual task performance. Unlike conventional physiotherapy approaches, dual task training aims to improve both motor performance and cognitive performance at the same time. Geriatric rehabilitation approaches in Turkey; single task training (containing only motor performance) is applied to older adults for walking and balance disorders. Recent studies have shown gait parameters and balance abilities are influenced cognitive function and also dual task training is had to include in rehabilitation programs in order to improve walking and balance skills of the healthy elderly. In Turkey, a similar study is not found. The goal of this study is to evaluate in healthy elderly, effect of dual-task and single-task training on gait performance, and their effect on the balance abilities and functional mobility also to evaluate advantages one to another and to gain a different perspective to geriatric rehabilitation for the elderly in Turkey.
Detailed description
Protocol:
In this study, the demographic information (age, gender, body mass index, education level, occupation, etc.) of all participants will be recorded first. In the first evaluation, the participants' gait parameters will be determined by using the 10-meter walking test and the wearable sensors. Balance is evaluated by Functional Reach Test, One Leg Stand Test and Tinetti Balance and Gait Assessment. Cognitive skills will be evaluated by using Mini Mental Test and Stroop Test. After the first evaluations of the participants, the participants will be given single or dual task training for 6 weeks, 2 times a week, not on consecutive days. If participants are absent for any training session, a compensation training session will be organized for them. After completing the single and / or dual task training, the final evaluations will be made. Randomization will be performed according to age, gender and body mass index of participants. After the randomization, participants' training group will be determined. Warm-up and cooling exercises will be carried out between 5-10 minutes before and after each training. Each training will consist of approximately 45-60 minutes including warm-up and cooling exercise periods. Each exercise starts with 5 repetitions and proceeds to 10 repetitions. To reduce the effects of fatigue and to draw attention, a break time that consists of approximately 1-2 minutes will be given.
Statistical Analysis:
The effect size obtained in the reference study was strong (d = 1.16). As a result of the power analysis using the effect size value in the reference study for the study, it was calculated that 80% power could be obtained at 95% confidence level when at least 20 people (10 people per group) were included the study. The data will be analyzed with Statistical Package for the Social Sciences (SPSS) package program. Continuous variables will be given as mean ± standard deviation and categorical variables as number and percentage. In the independent group comparisons, if the parametrical test assumptions are obtained, independent samples t-test will be used if the parametric test assumptions are not obtained Mann Whitney U test will be used. In the dependent group comparisons, when the parametric test assumptions are obtained, paired samples t-test; if not obtained Wilcoxon tests will be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Task Training Group | Active comparator | Other: ExerciseGait and balance exercises will be applied in single task training group. * Semi-tandem, tandem stand with eyes open and close * One leg stance with eyes open and close * Gait exercises; walking forwards, backwards, sidewards, semi-tandem and tandem walking * Reaching forward and sidewards with eyes open and close |
| Dual Task Training Group | Experimental | Other: ExerciseThe exercises given in the single task training group will be combined with the cognitive tasks. * Semi-tandem, tandem stand with recall a sequence of numbers * One leg stance with writing pre-defined letters or words with other foot * Semi-tandem or tandem walking with saying previous number (one or two previous) from number that researcher has given before * Walking sidewards with collecting numbers that researcher has given * Walking backwards with counting forward by one (then two or three) * Reaching forward with counting backward one (then two or three) * Reaching sidewards with saying next number (one or two next) from number that researcher has given before |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least to graduate from primary school or ability to read and write
- Mini mental test score> 24
- Ability to achieve daily living activities independently
- Ability to walk independently in the community (at least 10 meters without walking aids)
Key exclusion criteria (2 listed)
- Presence of acute (fracture, surgery), chronic (Parkinson's diseases, diabetes or stroke) and cognitive (Alzheimer, dementia, etc.) diseases
- Presence of hearing impairment that cannot be resolved by hearing devices and presence visual impairment that cannot be resolved by hearing aids.
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 |
|---|---|---|
| ExerciseSingle Task Training: Single task training includes exercises that require only one task or stimulation. For this study the task consists of motor tasks (walking or balance) Dual Task Training: Dual task training includes exercises simultaneous performance of two tasks that can be performed independently, measured separately and with different goals. In the study motor tasks will combine with cognitive tasks. | Other | Dual Task Training Group, Single Task Training Group |
Primary outcome
10 meter walk test
Time frame: six week
This test will perform with wearable gait sensors and will evaluate gait parameters.
Functional Reach Test
Time frame: six week
Balance test
One Leg stand Test
Time frame: six week
Balance test
Tinetti balance and gait assessment
Time frame: six week
For evaluating balance and gait
Stroop test
Time frame: six week
cognitive test
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 14 Jan 2021.
- Background: PubMed 24707083Shin SS, An DH. The Effect of Motor Dual-task Balance Training on Balance and Gait of Elderly Women. J Phys Ther Sci. 2014 Mar;26(3):359-61. doi: 10.1589/jpts.26.359. Epub 2014 Mar 25.
- Background: PubMed 29245071Brustio PR, Rabaglietti E, Formica S, Liubicich ME. Dual-task training in older adults: The effect of additional motor tasks on mobility performance. Arch Gerontol Geriatr. 2018 Mar-Apr;75:119-124. doi: 10.1016/j.archger.2017.12.003. Epub 2017 Dec 10.
- Derived from this study: PubMed 33226605Tasvuran Horata E, Cetin SY, Erel S. Effects of individual progressive single- and dual-task training on gait and cognition among older healthy adults: a randomized-controlled comparison study. Eur Geriatr Med. 2021 Apr;12(2):363-370. doi: 10.1007/s41999-020-00429-5. Epub 2020 Nov 23.
- Individual participant dataSharing planned: No
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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.
Suat EREL study director
PhD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Aging, run by Pamukkale University 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 4 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 14 Jan 2021. 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?
10 meter walk test (time frame: six week). 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 NCT03777111, which also lists 3 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 14 Jan 2021.