- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04577092
Dual Task Training for Balance in Older Adults
Do Motor-cognitive and Motor-motor Dual Task Training Effect Differently Balance Performance in Older Adults?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34160
- Istanbul Aydin University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- (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
Exclusion Criteria:
- (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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Motor-Cognitive
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. |
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.
|
Active Comparator: Motor-Motor
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.
|
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.
In 10-minute cool down period, stretching of quadriceps femoris muscle, hamstring muscle, achill tendon and cervical muscles were performed.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline (first assessment)
|
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
|
End of the training (8 weeks after)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Falls Efficacy Scale International (FES-I)
Time Frame: baseline (first assessment)
|
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.
|
baseline (first assessment)
|
Falls Efficacy Scale International (FES-I)
Time Frame: End of the training (8 weeks after)
|
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.
|
End of the training (8 weeks after)
|
Timed Up and Go (TUG)
Time Frame: baseline (first assessment)
|
(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.
|
baseline (first assessment)
|
Timed Up and Go (TUG)
Time Frame: End of the training (8 weeks after)
|
(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.
|
End of the training (8 weeks after)
|
Muscle Testing (MT)
Time Frame: baseline (first assessment)
|
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.
|
baseline (first assessment)
|
Muscle Testing (MT)
Time Frame: End of the training (8 weeks after)
|
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.
|
End of the training (8 weeks after)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Charlson Comorbidity Index (CCI)
Time Frame: baseline (first assessment)
|
CCI was used to measure the comorbidity status of participants.
It investigates existence of 17 comorbidities.
The final score indicates disease burden and is a good estimator of mortality.
|
baseline (first assessment)
|
Collaborators and Investigators
Investigators
- Study Director: Hanifegul Taskiran, PT, Prof, İstanbul Aydın University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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