GeriatricsNCT04577092
Dual Task Training for Balance in Older Adults
A study testing Warm-up exercise, Motor-Cognitive exercise and Motor-Motor exercise in people with Geriatrics, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Dual task training (DTT) have been showed that have satisfying effects on older adults. The aim of this study was to compare the effect of motor-cognitive DTT (mCdtt) and motor-motor DTT (mMdtt) on balance, fear of falling, walking functionality and muscle strength in older adults. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Geriatrics
- What is being tested?
- Warm-up exercise, Motor-Cognitive exercise and Motor-Motor exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 18 Mar 2018
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (1) age over 60 years old
- (2) score ≥ 24 on the Mini-Mental State Exam
- (3) category of walking ability ≥ 4 according to the Functional Ambulation Category
- (4) no problem in visual ability and hearing
Who cannot join
- (1) a history of specific balance problems (i.e., diagnosed neurological, musculoskeletal or vestibular disorder)
- (2) history of cerebrovascular occasion
- (3) history of hip-knee surgery
- (4) use of medication(s) such as sedatives and hypnotics, antidepressants and benzodiazepines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Motor-cognitive and Motor-motor Dual Task Training Effect Differently Balance Performance in Older Adults?
Dual task training (DTT) have been showed that have satisfying effects on older adults. The aim of this study was to compare the effect of motor-cognitive DTT (mCdtt) and motor-motor DTT (mMdtt) on balance, fear of falling, walking functionality and muscle strength in older adults. The participants were divided into two groups; who received mCdtt (Group 1) and who received mMdtt (Group 2). The intervention program had lasted for 8 weeks.
Read the detailed description
Dual task training (DTT) have been showed that have satisfying effects on older adults. The aim of this study is comparing the effect of motor-cognitive DTT (mCdtt) and motor-motor DTT (mMdtt) on balance, fear of falling, walking functionality and muscle strength in older adults. A total of 50 participants aged 60 and over (mean age: 67.72±7.33 years), having a score ≥ 24 on the Mini-Mental State Exam (MMSE), being in category of walking ability ≥ 4 according to the Functional Ambulation Category (FAC), having no problem in visual ability and hearing were included for this study. The participants who received mCdtt (Group 1) counted back from the two-digit number and the participants who received mMdtt (Group 2) held half-filled glasses with 90o flexion elbow with both hand while performing exercises. The intervention program had lasted for 8 weeks. To assess balance, fear of falling, walking functionality and muscle strength of participants, Berg Balance Scale (BBS), Falls Efficacy Scale International (FES-I), Timed Up and Go (TUG) and Hand-held dynamometer were used, respectively.
- Conditions
- Geriatrics
- Being tested
- Warm-up exercise, Motor-Cognitive exercise, Motor-Motor exercise, Cool-down exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm-up exerciseOther
In 10-minute warm up period; neck flexion/extension/side flexion/circumflexion (clockwise and counterclockwise), rounding shoulder back and forth, circumflexion of arm back and forth, side flexion of trunk and rising on the fingertips.
Motor-Cognitive exerciseOther
After warm up period; participants had been asked to count back from the two-digit number while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion.
Motor-Motor exerciseOther
participants had been asked to hold with both hand half-filled glasses with 90 degree of flexion elbow and near the trunk while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion.
Cool-down exerciseOther
In 10-minute cool down period, stretching of quadriceps femoris muscle, hamstring muscle, achill tendon and cervical muscles were performed.
| Study group | Role | What they receive |
|---|---|---|
| Motor-Cognitive | Active comparator | In 10-minute warm up period; neck flexion/extension/side flexion/circumflexion (clockwise and counterclockwise), rounding shoulder back and forth, circumflexion of arm back and forth, side flexion of trunk and rising on the fingertips. After warm up period; participants had been asked to count back from the two-digit number while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion.
In 10-minute cool down period, stretching of quadriceps femoris muscle, hamstring muscle, achill tendon and cervical muscles were performed. Receives: Other: Warm-up exercise; Other: Motor-Cognitive exercise; Other: Cool-down exercise |
| Motor-Motor | Active comparator | In 10-minute warm up period; neck flexion/extension/side flexion/circumflexion (clockwise and counterclockwise), rounding shoulder back and forth, circumflexion of arm back and forth, side flexion of trunk and rising on the fingertips. After warm up period; participants had been asked to hold with both hand half-filled glasses with 90 degree of flexion elbow and near the trunk while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion. In cool down period, stretching of quadriceps femoris muscle, hamstring muscle, achill tendon and cervical muscles were performed. Receives: Other: Warm-up exercise; Other: Motor-Motor exercise; Other: Cool-down exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
BBS is a widely used, reliable and valid scale, which was developed to measure balance in older adults with functional postures and movements. It consists of 14 items scoring from 0 (unable/unsafe) to 4 (independent/safe). The highest score was 56 and means the best ability of balance. Score of 0-20, 21-40 and 41-56 mean bad, fair and good ability of balance, respectively
Measured: baseline (first assessment)
Berg Balance Scale (BBS)
BBS is a widely used, reliable and valid scale, which was developed to measure balance in older adults with functional postures and movements. It consists of 14 items scoring from 0 (unable/unsafe) to 4 (independent/safe). The highest score was 56 and means the best ability of balance. Score of 0-20, 21-40 and 41-56 mean bad, fair and good ability of balance, respectively
Measured: End of the training (8 weeks after)
Secondary outcomes (6)
Falls Efficacy Scale International (FES-I)
FES-I evaluates concerns about falling with 16 items consisting of social and physical activities. Each item can be replied as 1=not all concerned, 2=somewhat concerned 3=fairly concerned and 4=very concerned. Total score is in a range between 16 and 64, a higher score means higher concern about falling.
Measured: baseline (first assessment)
Falls Efficacy Scale International (FES-I)
FES-I evaluates concerns about falling with 16 items consisting of social and physical activities. Each item can be replied as 1=not all concerned, 2=somewhat concerned 3=fairly concerned and 4=very concerned. Total score is in a range between 16 and 64, a higher score means higher concern about falling.
Measured: End of the training (8 weeks after)
Timed Up and Go (TUG)
(TUG) test is a common, simple and quick test for the function, balance, gait and risk of fall assessment. The TUG was showed to be the most evidence-supported functional measure to evaluate risk of falls in older adults. To perform the test, the participants were asked to seat armchair with back support which was 46 cm above from the floor. The participants were instructed to stand up, walk a distance of 3 meters away from the seat as fast as possible, turn, walk back to seat and sit down. The time passed during this maneuver was recorded as seconds with a chronometer.
Measured: baseline (first assessment)
Timed Up and Go (TUG)
(TUG) test is a common, simple and quick test for the function, balance, gait and risk of fall assessment. The TUG was showed to be the most evidence-supported functional measure to evaluate risk of falls in older adults. To perform the test, the participants were asked to seat armchair with back support which was 46 cm above from the floor. The participants were instructed to stand up, walk a distance of 3 meters away from the seat as fast as possible, turn, walk back to seat and sit down. The time passed during this maneuver was recorded as seconds with a chronometer.
Measured: End of the training (8 weeks after)
Muscle Testing (MT)
MT was performed with Hand-held dynamometer (Lafeyette Instrument®, Lafeyette, IN) to assess power and ability for stability, in this study. Antigravity muscles (m. gluteus maximus, m. quadriceps femoris, m. gastrocnemius and m. tibialis anterior) were assessed while performing maximal volunteer isometric contraction (MVIC) and values were recorded as kg. N-1.
Measured: baseline (first assessment)
Muscle Testing (MT)
MT was performed with Hand-held dynamometer (Lafeyette Instrument®, Lafeyette, IN) to assess power and ability for stability, in this study. Antigravity muscles (m. gluteus maximus, m. quadriceps femoris, m. gastrocnemius and m. tibialis anterior) were assessed while performing maximal volunteer isometric contraction (MVIC) and values were recorded as kg. N-1.
Measured: End of the training (8 weeks after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start1 Sep 2017
- Primary completion12 Feb 2018
- Study completion18 Mar 2018
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 GeriatricsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybike Senel, Istanbul University - Cerrahpasa
- Investigators
- Hanifegul Taskiran, PT, Prof, Study director, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577092
- Sponsor's protocol ID
- 13
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akin H, Senel A, Taskiran H, Kaya Mutlu E. Do motor-cognitive and motor-motor dual task training effect differently balance performance in older adults? Eur Geriatr Med. 2021 Apr;12(2):371-378. doi: 10.1007/s41999-020-00434-8. Epub 2021 Jan 3.
PubMed 33389715
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Motor-cognitive and Motor-motor Dual Task Training Effect Differently Balance Performance in Older Adults?
- ClinicalTrials.gov ID
- NCT04577092
- Acronym / sponsor ID
- 13
- Conditions
- Geriatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 18 Mar 2018 (actual)
- First posted
- 6 Oct 2020 (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 (DTT) have been showed that have satisfying effects on older adults. The aim of this study was to compare the effect of motor-cognitive DTT (mCdtt) and motor-motor DTT (mMdtt) on balance, fear of falling, walking functionality and muscle strength in older adults. The participants were divided into two groups; who received mCdtt (Group 1) and who received mMdtt (Group 2). The intervention program had lasted for 8 weeks.
Detailed description
Dual task training (DTT) have been showed that have satisfying effects on older adults. The aim of this study is comparing the effect of motor-cognitive DTT (mCdtt) and motor-motor DTT (mMdtt) on balance, fear of falling, walking functionality and muscle strength in older adults. A total of 50 participants aged 60 and over (mean age: 67.72±7.33 years), having a score ≥ 24 on the Mini-Mental State Exam (MMSE), being in category of walking ability ≥ 4 according to the Functional Ambulation Category (FAC), having no problem in visual ability and hearing were included for this study. The participants who received mCdtt (Group 1) counted back from the two-digit number and the participants who received mMdtt (Group 2) held half-filled glasses with 90o flexion elbow with both hand while performing exercises. The intervention program had lasted for 8 weeks. To assess balance, fear of falling, walking functionality and muscle strength of participants, Berg Balance Scale (BBS), Falls Efficacy Scale International (FES-I), Timed Up and Go (TUG) and Hand-held dynamometer were used, respectively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Motor-Cognitive | Active comparator | Other: Warm-up exercise, Other: Motor-Cognitive exercise, Other: Cool-down exerciseIn 10-minute warm up period; neck flexion/extension/side flexion/circumflexion (clockwise and counterclockwise), rounding shoulder back and forth, circumflexion of arm back and forth, side flexion of trunk and rising on the fingertips. After warm up period; participants had been asked to count back from the two-digit number while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion. In 10-minute cool down period, stretching of quadriceps femoris muscle, hamstring muscle, achill tendon and cervical muscles were performed. |
| Motor-Motor | Active comparator | Other: Warm-up exercise, Other: Motor-Motor exercise, Other: Cool-down exerciseIn 10-minute warm up period; neck flexion/extension/side flexion/circumflexion (clockwise and counterclockwise), rounding shoulder back and forth, circumflexion of arm back and forth, side flexion of trunk and rising on the fingertips. After warm up period; participants had been asked to hold with both hand half-filled glasses with 90 degree of flexion elbow and near the trunk while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion. In cool down period, stretching of quadriceps femoris muscle, hamstring muscle, achill tendon and cervical muscles were performed. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1) age over 60 years old
- (2) score ≥ 24 on the Mini-Mental State Exam
- (3) category of walking ability ≥ 4 according to the Functional Ambulation Category
- (4) no problem in visual ability and hearing
Key exclusion criteria (4 listed)
- (1) a history of specific balance problems (i.e., diagnosed neurological, musculoskeletal or vestibular disorder)
- (2) history of cerebrovascular occasion
- (3) history of hip-knee surgery
- (4) use of medication(s) such as sedatives and hypnotics, antidepressants and benzodiazepines.
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 |
|---|---|---|
| Warm-up exerciseIn 10-minute warm up period; neck flexion/extension/side flexion/circumflexion (clockwise and counterclockwise), rounding shoulder back and forth, circumflexion of arm back and forth, side flexion of trunk and rising on the fingertips. | Other | Motor-Cognitive, Motor-Motor |
| Motor-Cognitive exerciseAfter warm up period; participants had been asked to count back from the two-digit number while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion. | Other | Motor-Cognitive |
| Motor-Motor exerciseparticipants had been asked to hold with both hand half-filled glasses with 90 degree of flexion elbow and near the trunk while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion. | Other | Motor-Motor |
| Cool-down exerciseIn 10-minute cool down period, stretching of quadriceps femoris muscle, hamstring muscle, achill tendon and cervical muscles were performed. | Other | Motor-Cognitive, Motor-Motor |
Primary outcome
Berg Balance Scale (BBS)
Time frame: baseline (first assessment)
BBS is a widely used, reliable and valid scale, which was developed to measure balance in older adults with functional postures and movements. It consists of 14 items scoring from 0 (unable/unsafe) to 4 (independent/safe). The highest score was 56 and means the best ability of balance. Score of 0-20, 21-40 and 41-56 mean bad, fair and good ability of balance, respectively
Berg Balance Scale (BBS)
Time frame: End of the training (8 weeks after)
BBS is a widely used, reliable and valid scale, which was developed to measure balance in older adults with functional postures and movements. It consists of 14 items scoring from 0 (unable/unsafe) to 4 (independent/safe). The highest score was 56 and means the best ability of balance. Score of 0-20, 21-40 and 41-56 mean bad, fair and good ability of balance, respectively
6 secondary outcomes
Falls Efficacy Scale International (FES-I)
Time frame: baseline (first assessment)
Falls Efficacy Scale International (FES-I)
Time frame: End of the training (8 weeks after)
Timed Up and Go (TUG)
Time frame: baseline (first assessment)
Timed Up and Go (TUG)
Time frame: End of the training (8 weeks after)
Muscle Testing (MT)
Time frame: baseline (first assessment)
Muscle Testing (MT)
Time frame: End of the training (8 weeks after)
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 6 Oct 2020.
- Derived from this study: PubMed 33389715Akin H, Senel A, Taskiran H, Kaya Mutlu E. Do motor-cognitive and motor-motor dual task training effect differently balance performance in older adults? Eur Geriatr Med. 2021 Apr;12(2):371-378. doi: 10.1007/s41999-020-00434-8. Epub 2021 Jan 3.
- 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.
Hanifegul Taskiran, PT, Prof study director
Istanbul Aydın 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 Warm-up exercise, Motor-Cognitive exercise and Motor-Motor exercise in people with Geriatrics, run by Istanbul University - Cerrahpasa 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 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 6 Oct 2020. 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: baseline (first assessment)). The study lists 2 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 NCT04577092, 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 6 Oct 2020.