Dual Task Exercises in Elderly PeopleNCT03981692
The Effect of Two Different Dual Task Balance Trainings in Older Adults
A study testing Consecutive dual task and Integrated dual task in people with Dual Task Exercises in Elderly People, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the effect of integrated and consecutive dual-task exercise trainings in elderly people on the balance, fear of falling and gait performance. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dual Task Exercises in Elderly People
- What is being tested?
- Consecutive dual task and Integrated dual task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2019to 24 Jun 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Accepts to start routine exercise programs under the supervision of the medical team,
- Over age 65,
- Does not have orthopedic problems that may prevent him from exercising,
- The MOCA score is 21 or higher,
- Participants who have no other neurological problems that may cause loss of balance will be taken.
Who cannot join
- Having orthopedic problems that prevent him from exercising,
- Being under the MOCA score 21,
- To have any neurological problem that will affect the balance,
- Not wanting to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Darüşşafaka Physical Therapy and Rehabilitation Center
Istanbul, Maltepe, 34848
About this study
Official title: The Effect of Two Different Dual Task Balance Trainings on Balance and Gait in Older Adults
The aim of our study is to investigate the effect of integrated and consecutive dual-task exercise trainings in elderly people on the balance, fear of falling and gait performance.
Read the detailed description
For the purpose, the number of 42 participants reached by the power analysis method was determined as 60 people considering the possible separations. 60 participants will be included in the study. Participants should not have any orthopedic, neurological and cognitive disabilities and the Montreal Cognitive Assessment (MOCA) scale score should be 21 or higher. Participants will be divided into two groups as random consecutive and integrated dual activity groups.
In the study sit-up, stand on one leg (eye open-closed), standing 30 sec stop (eye open closed stop), 10 m walk backward, sitting on top of the ball (eye open-closed), transfer of weight on the top-left, walking in straight line, 30 sec. stop on soft ground (eye open-close), balance training which does not force their efforts will be given in two groups.
For the sequential dual activity group, immediately after these trainings, you should expected to find the letters Z in the mixed letters, search for the five words you read on the previous page, find the similarities between the concepts, find the letter in the given tables, derive the fruit names starting with the letter, count the days of the week etc. Attention, memory and arithmetic training will be given the ability to run. For the integrated dual activity group will be given similar cognitive tasks during simple balance training.
The training program will be prolonged 8 weeks and 2 days per week for both groups.
The assessment tests was performed before and after the program. Primer Outcome Measure: Berg Balance Scale, Timed Up and Go Test (Standart-Cognitive), 10m Walking Speed Test (under single and dual task conditions).
Although there are many studies to increase and measure the balance and physical capacity of elderly people in the literature, there is no study using consecutive exercises and comparing the benefits of consecutive and integrated cognitive dual task training.
A major cause of morbidity and mortality is a fall injury in the elderly. Therefore, preventing falls in elderly people and increasing the ability to balance is an important public health priority.
Our study aims to benefit the public health, the reduction of health expenses of our country, the physiotherapists working with elderly people and the literature.
- Conditions
- Dual Task Exercises in Elderly People
- Being tested
- Consecutive dual task, Integrated dual task
- Keywords
- Elderly, Balance, Gait speed, Cognitive, Dual task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consecutive dual taskOther
8 weeks and 2 days per week, one session 45 min. Consecutive dual task creates the idea that it may provide more workable work without creating stress while doing secondary task during dual task.
Integrated dual taskOther
8 weeks and 2 days per week, one session 45 min. Integrated dual task is a proven mode of work that has positive effects on geriatrics
| Study group | Role | What they receive |
|---|---|---|
| Consecutive Dual Task Training | Active comparator | Sit-up, stand on one leg (eye open-closed), standing 30 sec stop (eye open closed stop), 10 m walk backward, sitting on top of the ball (eye open-closed), transfer of weight on the top-left, walking in straight line, 30 sec. stop on soft ground (eye open-close), balance training which does not force their efforts will be given to the group. Immediately after these trainings, they should expected to find the letters Z in the mixed letters, search for the five words you read on the previous page, find the similarities between the concepts, find the letter in the given tables, derive the fruit names starting with the letter, count the days of the week etc. Attention, memory and arithmetic training will be given the ability to run. Receives: Other: Consecutive dual task |
| Integrated Dual Task Training | Active comparator | Sit-up, stand on one leg (eye open-closed), standing 30 sec stop (eye open closed stop), 10 m walk backward, sitting on top of the ball (eye open-closed), transfer of weight on the top-left, walking in straight line, 30 sec. stop on soft ground (eye open-close), balance training which does not force their efforts will be given to the group. They will be done similar cognitive activities during with this simple balance trainings. Receives: Other: Integrated dual task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities, named after Katherine Berg, one of the developers. For functional balance tests, the BBS is generally considered to be the gold standard.
The test takes 15-20 minutes and comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot. The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.
Minimum score is 0 while maximum score is 56. The classification; 0-20 scores - wheelchair user, 21-44 scores - walking with assistance 45-56 scores - independent.
The test was performed at baseline and after Intervention (8 weeks)
Measured: 15 minutes
Secondary outcomes (5)
Timed Up and Go test (TUGST)
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. Description of the Instrument. Patients are timed (in seconds) when performing the TUG-3 conditions 1. TUG alone-from sitting in a chair, stand up, walk 3 meters, turn around, walk back, and sit down.. 2. TUG Cognitive-complete the task while counting backwards from a randomly selected number between 20 and 100.
The test was performed at baseline and after Intervention (8 weeks)
Measured: 5 minutes
Timed Up and Go test Cognitive (TUGCOG)
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. Description of the Instrument. Patients are timed (in seconds) when performing the TUG-3 conditions 1. TUG alone-from sitting in a chair, stand up, walk 3 meters, turn around, walk back, and sit down.. 2. TUG Cognitive-complete the task while counting backwards from a randomly selected number between 20 and 100.
When a cognitive task is added while performing the test, it is called Timed Up and Go Cognitive.
The test was performed at baseline and after Intervention (8 weeks)
Measured: 5 minutes
10 Meters Walking Test Under Dual Task Condition (10MWTDT)
The standard 10 m walking test is performed while performing a second activity simultaneously. There are many additional task suggestions that can be given during the walk. One of these suggestions is the "counting backwards" task as a cognitive task.
The test was performed at baseline and after Intervention (8 weeks)
Measured: 5 minutes
10 Meters Walking Test Under Single Task Condition (10MWTST)
Measures the time required to walk 10 meters. Administration time is usually less than 5 minutes. Performed using a "flying start": the patient walks 14 meters and the time is measured for the intermediate 10 meters. The individual walks at their preferred walking speed. It is aimed to measure walking speed.
The test was performed at baseline and after Intervention (8 weeks)
Measured: 5 minutes
Tinetti Falls Efficacy Scale (FES)
A 10-item questionnaire designed confidence in their ability to perform 10 daily tasks without falling as an indicator of how one's fear of falling impacts physical performance. Each item is rated from 1 ("very confident") to 10 ("not confident at all"), and the per item ratings are added to generate a summary.
The test was performed at baseline and after Intervention (8 weeks)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start8 Apr 2019
- Primary completion3 Jun 2019
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dual Task Exercises in Elderly PeopleStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study; sit-up, stand on one leg (eye open-closed), standing 30 sec stop (eye open closed stop), 10 m walk backward, sitting on top of the ball (eye open-closed), transfer of weight on the top-left, walking in a straight line, 30 sec. stop on soft ground (eye open-close), balance training which does not force their efforts will be given in two groups. Group 1: Integrated Dual Task Training Group performed balance and cognitive tasks simultaneously. Group 2: Consecutive Dual Task Training Group performed balance and cognitive tasks sequentially. The cognitive tasks; They were expected to find the letters Z in the mixed letters, search for the five words you read on the previous page, find the similarities between the concepts, find the letter in the given tables, derive the fruit names starting with the letter, count the days of the week, etc. Attention, memory and arithmetic training will be given the ability to run.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Volkan Yüzlü, PT MSc, Principal investigator, Darüşşafaka Physical Therapy and Rehabilitation CenterSemra Oğuz, PhD, Study director, Marmara UniversityMine Gülden Polat, Prof PhD, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981692
- Sponsor's protocol ID
- 09.2019.181
- Status last verified
- May 2021
- First submitted
- 7 Jun 2019
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuzlu V, Oguz S, Timurtas E, Aykutoglu E, Polat MG. The Effect of 2 Different Dual-Task Balance Training Methods on Balance and Gait in Older Adults: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab298. doi: 10.1093/ptj/pzab298.
PubMed 34972869
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Dual Task Balance Trainings on Balance and Gait in Older Adults
- ClinicalTrials.gov ID
- NCT03981692
- Acronym / sponsor ID
- 09.2019.181
- Conditions
- Dual Task Exercises in Elderly People
- Keywords
- Elderly, Balance, Gait speed, Cognitive, Dual task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 11 Jun 2019 (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.
The aim of our study is to investigate the effect of integrated and consecutive dual-task exercise trainings in elderly people on the balance, fear of falling and gait performance.
Detailed description
For the purpose, the number of 42 participants reached by the power analysis method was determined as 60 people considering the possible separations. 60 participants will be included in the study. Participants should not have any orthopedic, neurological and cognitive disabilities and the Montreal Cognitive Assessment (MOCA) scale score should be 21 or higher. Participants will be divided into two groups as random consecutive and integrated dual activity groups.
In the study sit-up, stand on one leg (eye open-closed), standing 30 sec stop (eye open closed stop), 10 m walk backward, sitting on top of the ball (eye open-closed), transfer of weight on the top-left, walking in straight line, 30 sec. stop on soft ground (eye open-close), balance training which does not force their efforts will be given in two groups.
For the sequential dual activity group, immediately after these trainings, you should expected to find the letters Z in the mixed letters, search for the five words you read on the previous page, find the similarities between the concepts, find the letter in the given tables, derive the fruit names starting with the letter, count the days of the week etc. Attention, memory and arithmetic training will be given the ability to run. For the integrated dual activity group will be given similar cognitive tasks during simple balance training.
The training program will be prolonged 8 weeks and 2 days per week for both groups.
The assessment tests was performed before and after the program. Primer Outcome Measure: Berg Balance Scale, Timed Up and Go Test (Standart-Cognitive), 10m Walking Speed Test (under single and dual task conditions).
Although there are many studies to increase and measure the balance and physical capacity of elderly people in the literature, there is no study using consecutive exercises and comparing the benefits of consecutive and integrated cognitive dual task training.
A major cause of morbidity and mortality is a fall injury in the elderly. Therefore, preventing falls in elderly people and increasing the ability to balance is an important public health priority.
Our study aims to benefit the public health, the reduction of health expenses of our country, the physiotherapists working with elderly people and the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In the study; sit-up, stand on one leg (eye open-closed), standing 30 sec stop (eye open closed stop), 10 m walk backward, sitting on top of the ball (eye open-closed), transfer of weight on the top-left, walking in a straight line, 30 sec. stop on soft ground (eye open-close), balance training which does not force their efforts will be given in two groups. Group 1: Integrated Dual Task Training Group performed balance and cognitive tasks simultaneously. Group 2: Consecutive Dual Task Training Group performed balance and cognitive tasks sequentially. The cognitive tasks; They were expected to find the letters Z in the mixed letters, search for the five words you read on the previous page, find the similarities between the concepts, find the letter in the given tables, derive the fruit names starting with the letter, count the days of the week, etc. Attention, memory and arithmetic training will be given the ability to run.
| Arm | Type | Receives |
|---|---|---|
| Consecutive Dual Task Training | Active comparator | Other: Consecutive dual taskSit-up, stand on one leg (eye open-closed), standing 30 sec stop (eye open closed stop), 10 m walk backward, sitting on top of the ball (eye open-closed), transfer of weight on the top-left, walking in straight line, 30 sec. stop on soft ground (eye open-close), balance training which does not force their efforts will be given to the group. Immediately after these trainings, they should expected to find the letters Z in the mixed letters, search for the five words you read on the previous page, find the similarities between the concepts, find the letter in the given tables, derive the fruit names starting with the letter, count the days of the week etc. Attention, memory and arithmetic training will be given the ability to run. |
| Integrated Dual Task Training | Active comparator | Other: Integrated dual taskSit-up, stand on one leg (eye open-closed), standing 30 sec stop (eye open closed stop), 10 m walk backward, sitting on top of the ball (eye open-closed), transfer of weight on the top-left, walking in straight line, 30 sec. stop on soft ground (eye open-close), balance training which does not force their efforts will be given to the group. They will be done similar cognitive activities during with this simple balance trainings. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Accepts to start routine exercise programs under the supervision of the medical team,
- Over age 65,
- Does not have orthopedic problems that may prevent him from exercising,
- The MOCA score is 21 or higher,
- Participants who have no other neurological problems that may cause loss of balance will be taken.
Key exclusion criteria (4 listed)
- Having orthopedic problems that prevent him from exercising,
- Being under the MOCA score 21,
- To have any neurological problem that will affect the balance,
- Not wanting to participate in the study.
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 |
|---|---|---|
| Consecutive dual task8 weeks and 2 days per week, one session 45 min. Consecutive dual task creates the idea that it may provide more workable work without creating stress while doing secondary task during dual task. | Other | Consecutive Dual Task Training |
| Integrated dual task8 weeks and 2 days per week, one session 45 min. Integrated dual task is a proven mode of work that has positive effects on geriatrics | Other | Integrated Dual Task Training |
Primary outcome
Berg Balance Scale (BBS)
Time frame: 15 minutes
The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities, named after Katherine Berg, one of the developers. For functional balance tests, the BBS is generally considered to be the gold standard. The test takes 15-20 minutes and comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot. The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores. Minimum score is 0 while maximum score is 56. The classification; 0-20 scores - wheelchair user, 21-44 scores - walking with assistance 45-56 scores - independent. The test was performed at baseline and after Intervention (8 weeks)
5 secondary outcomes
Timed Up and Go test (TUGST)
Time frame: 5 minutes
Timed Up and Go test Cognitive (TUGCOG)
Time frame: 5 minutes
10 Meters Walking Test Under Dual Task Condition (10MWTDT)
Time frame: 5 minutes
10 Meters Walking Test Under Single Task Condition (10MWTST)
Time frame: 5 minutes
Tinetti Falls Efficacy Scale (FES)
Time frame: 5 minutes
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 2021.
- Derived from this study: PubMed 34972869Yuzlu V, Oguz S, Timurtas E, Aykutoglu E, Polat MG. The Effect of 2 Different Dual-Task Balance Training Methods on Balance and Gait in Older Adults: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab298. doi: 10.1093/ptj/pzab298.
- 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.
Volkan Yüzlü, PT MSc principal investigator
Darüşşafaka Physical Therapy and Rehabilitation Center
Semra Oğuz, PhD study director
Marmara University
Mine Gülden Polat, Prof PhD study chair
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consecutive dual task and Integrated dual task in people with Dual Task Exercises in Elderly People, run by Marmara 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 5 inclusion and 4 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 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?
Berg Balance Scale (BBS) (time frame: 15 minutes). 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 NCT03981692, which also lists 1 linked publication.
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 2021.