Effects of Single and Dual Task Training in Individuals With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Comparison of the Effects of Single and Dual Task Training on Processing Speed, Cognitive Functions, Walking Speed, Dual Task Performance and Balance Functions in Individuals With Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301960
• Other study ID #: 2019/23-11
• Status: Completed
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: June 16, 2021

Study information

• Verified date: June 2021
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the effects of single and dual-task training on processing speed, cognitive functions, walking speed, dual-task performance and balance functions in individuals with mild cognitive impairment.

Description:

Mild Cognitive Impairment (MCI) is a cognitive impairment that usually occurs with the normal cognitive decline with age and does not significantly affect daily function. MCI is diagnosed by the presence of one or more cognitive deficits that occur without meeting the diagnostic criteria of dementia. MCI is regarded as an intermediate stage between normal cognition and dementia. Also known as the early stage of dementia. Although 6 main cognitive domains could potentially be affected (learning and memory, social functioning, language, visuospatial function, complex attention, or executive functioning), the term "mild cognitive impairment" generally refers to a decline in the ability to learn new information or recall stored information. While the current dementia criteria require that cognitive functions be impaired to prevent an individual from continuing his/her daily life independently, MCI is the stage where there is no significant problem in the daily life of the individual before this stage. Risk factors include male sex, presence of the apolipoprotein E allele, family history of cognitive impairment, and the presence of vascular risk factors such as hypertension, hyperlipidemia, coronary artery disease, and stroke.

Training of cognitive functions with physiotherapy can be effective in improving various aspects of objective cognitive functioning (memory performance, executive functioning, processing speed, attention, fluid intelligence, and subjective cognitive performance). It has been reported that there is a slowdown or decrease in cognitive status through training. In the literature, there were no studies comparing single and dual-task training effects in patients with mild cognitive impairment. Therefore, the aim of this study is to compare the effects of single and dual-task training on the processing speed, cognitive functions, walking speed, dual-task performance and balance functions in individuals with mild cognitive impairment.

Participants who are between the ages of 65-85, who has Montreal Cognitive Assessment score between 13-26, the Quick Mild Cognitive Impairment Screen score between 48-67, Instrumental Activities of Daily Living Scale score ≥6/8, who says yes to "Do you have a memory problem?", who can walk independently without using any walking aids and who are likely to be MCI as a result of the tests will be referred to the neurologist and those whose diagnosis is confirmed will be included in this study. Participants who have any musculoskeletal disorders that may cause balance and gait disorders, central or peripheral neurological diseases (eg. stroke, Parkinson's disease or polyneuropathies), using psychiatric drugs that may affect psychiatric disease and / or cognitive performance, daltonism diagnosed and who attending any exercise program will not be included in this study.

All the participants will be measured with Choice Stepping Reaction Time (CSRT) Test, Stroop Test, backward counting, verbal fluency, 10 meters walking test (10MWT), 10MWT with backward counting and verbal fluency for dual tasking, Fullerton Advanced Balance (FAB) Scale and D+R Balance Application. The measurements will be made at the beginning of the treatment (0 week) and at the end of the treatment (8 weeks).

The choice stepping reaction time (CSRT) task has been better to discriminate between fallers and non-fallers than other sensorimotor and balance measures and to predict falls in older people, mediated through physiologic and cognitive pathways.

The single task group includes balance gaining and cognitive training. In the dual-task group includes CSRT Mat training.

The single task group will have 30-40 minutes of single-task training for 3 sessions per week for 8 weeks. The dual-task group will have CSRT Mat training for 30-40 minutes of dual-task training for 3 sessions per week for 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 16, 2021
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Participants who are between 65-85 years of age,

2. Who has the Montreal Cognitive Assessment score between 13-26,

3. Who has the Quick Mild Cognitive Impairment screen score between 48-67,

4. Who has Instrumental Activities of Daily Living Scale score =6/8,

5. Who says yes to "Do you have a memory problem?" question,

6. Who can walk independently without using any walking aids and

7. Who is likely to have mild cognitive impairment as a result of the tests will be referred to the neurologist and those whose diagnosis is confirmed will be included in this study.

Exclusion Criteria:

1. Participants who have any musculoskeletal disorders that may cause balance and gait disorders,

2. Who have central or peripheral neurological diseases (eg. stroke, Parkinson's disease or polyneuropathies),

3. Who are using psychiatric drugs that may affect psychiatric disease and/or cognitive performance,

4. Who has daltonism and

5. Who attends any exercise program will not be included in this study.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• Single task training
The single task group includes balance gaining and cognitive training. The single task group will have 30-40 minutes of single-task training for 3 sessions per week for 8 weeks.
• Dual task training
The dual-task group includes CSRT Mat training. The dual-task group will have CSRT Mat training for 30-40 minutes of dual-task training for 3 sessions per week for 8 weeks.

Locations

Country	Name	City	State
Cyprus	Eastern Mediterranean University	Famagusta	Eyalet/Yerleske

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

References & Publications (3)

Faria CA, Alves HVD, Charchat-Fichman H. The most frequently used tests for assessing executive functions in aging. Dement Neuropsychol. 2015 Apr-Jun;9(2):149-155. doi: 10.1590/1980-57642015DN92000009. — View Citation

Iyigun G, Kirmizigil B, Angin E, Oksuz S, Can F, Eker L, Rose DJ. The reliability and validity of the Turkish version of Fullerton Advanced Balance (FAB-T) scale. Arch Gerontol Geriatr. 2018 Sep - Oct;78:38-44. doi: 10.1016/j.archger.2018.05.022. Epub 2018 Jun 4. — View Citation

Schoene D, Delbaere K, Lord SR. Impaired Response Selection During Stepping Predicts Falls in Older People-A Cohort Study. J Am Med Dir Assoc. 2017 Aug 1;18(8):719-725. doi: 10.1016/j.jamda.2017.03.010. Epub 2017 May 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choice Stepping Reaction Time Test (CSRT)	A custom-made Choice Stepping Reaction Time step pad (CSRT-MAT) and a computer unit will be used to evaluate the processing speed. The system is consisted of a CSRT-MAT having pressure-sensitive panels and a display monitor connected to a computer unit. The computer unit recorded the timing of foot lift and landing. The step direction is indicated by one arrow changing its color. The CSRT device included 2 tests: Stepping Reaction Time (SRT) and Stroop Test (ST). In this study, only the SRT test will be done. In the SRT test, the participants are asked to step as quickly as possible onto the corresponding arrow on the CSRT-MAT and then return to the center. The reaction time (RT) measured from stimulus occurrence to movement initiation (lift off), movement time (MT) measured from movement initiation to step finalization (step down) and total response time (RsT) measured as the sum of RT and MT.	8 weeks
Secondary	Stroop Test	The Stroop Color and Word Test (SCWT) will be used to assess selective attention. SCWT is a neuropsychological test extensively used for both experimental and clinical purposes. It assesses the ability to inhibit cognitive interference, which occurs when the processing of a stimulus feature a?ects the simultaneous processing of another attribute of the same stimulus. Named color-word (CW) condition, color-words are printed in an inconsistent color ink (for instance the word "red" is printed in green ink). Thus, in this incongruent condition, participants are required to name the color of the ink instead of reading the word. At the completion of the test, the number of incorrect responses and time of completion scores will be recorded. The test has a total of 50 questions and the application takes approximately 5 minutes.	8 weeks
Secondary	Verbal Fluency Test (VFT)	The Verbal Fluency Test (VFT) will be used to evaluate the verbal fluency ability of the participants. Verbal fluency is the ability to generate an appropriate strategy for word searching. The test consists of giving the person 1 minute to verbally list as many things as possible in a category. The verbal fluency test will be done in two different ways. The first one is semantic subtest, in this test the words are generated according to a category (such as 'animals' or 'fruits'). The other one is the phonological fluency subtest, in this test participants are asked to generate words according to the letter they begin with (such as 'F', 'A' or 'S') and on semantic fluency. The correct number of answers within 1 minute will be determined after the completion of the test by listening to voice recorder recordings.	8 weeks
Secondary	Serial Subtraction Test (SST)	The Serial Subtraction Test (SST) will be used to evaluate the arithmetic performance and mental tracking capacity of the participants. Counting backward is thought to be a simple mental tracking task, which requires the subject to hold information regarding a tracking number in mind while subsequently reversing the order of a set of numbers. The failure to count backward is likely caused by an intrusion of the inappropriate routine schema (e.g. the process of counting forward), as the process of counting forward is more acquired and automatic than that of counting backward. Therefore the investigators preferred to use the counting backward in this study. In this test, the participants will be asked to "subtract 7 from 100" (Serial 7s) and to keep going until they can't go any further".	8 weeks
Secondary	10 Meter Walking Test (10 MWT)	The 10 Meter Walk Test (10 MWT) is a performance measure used to assess walking speed in meters per second over a short distance. In 10 MWT individuals walk (at a normal pace) without assistance for 10 meters and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration. The timing is started when the toes of the leading foot cross the 2-meter mark and stoped at the 8-meter mark. The total time taken to ambulate 6 meters will be recorded and then divided by the total time (in seconds) in m/s.	8 weeks
Secondary	10 Meter Walking Test with Verbal Fluency Test (10 MWT-VFT)	The 10 Meter Walking Test with verbal fluency test (10 MWT-VFT) will be used to evaluate the dual-task (motor and cognitive) skills of the participants. In the 10 MWT-VFT, the participants will be evaluated during both conditions: verbal fluency and 10 MWT. While the patients are walking in they will be counting verbally as many things as possible in a category. The correct number of answers while walking will be determined after the completion of the test by listening to voice recorder recordings.	8 weeks
Secondary	10 Meter Walking Test with Serial Subtraction Test (10 MWT-SST)	The 10 Meter Walking Test with Serial Subtraction Test (10 MWT-SST) will be used to evaluate the dual-task (motor and cognitive) skills of the participants. In the 10 MWT-SST the participants will be evaluated during both conditions: serial subtraction and 10 MWT. While the patients are walking in they will be asked to "subtract 7 from 100" (Serial 7s) and to keep going until they can't go any further". The correct number of answers while walking will be determined after the completion of the test by listening to voice recorder recordings.	8 weeks
Secondary	Fullerton Advanced Balance (FAB) Scale	The Fullerton Advanced Balance (FAB) scale will be used to evaluate the balance performance of the participants. This performance-based scale consists of 10 test items assessing functional balance (static and dynamic) status. The individual test items are feet together, eyes closed (1), reach forward to retrieve an object (2), turn in a full circle (3), step up and over a bench (4), tandem walk (5), stand on one leg (6), stand on foam, eyes closed (7), two-footed jump (8), walk with head turns (9) and reactive postural control (10). Each test item is scored using a 0-4 scale. The highest score is 40 points, and the lowest is zero. Higher scores indicate better balance abilities. The FAB scale is quick to administer (~10-12 min) and can be administered in a relatively small area.	8 weeks
Secondary	D+R Balance Application	The D+R Balance Application of iPhone will be used to evaluate the postural sway of the participants. The iPhone will be inserted into an incase armband and will be strapped to the participant's right upper arm. Each dataset represents an area of an ellipse with two standard deviations in the anteroposterior and lateral planes about a mean point, taken over a period of 30 seconds. The resulting Kanegaonkar "K" value (200000 and - 15000) gives information about postural oscillation. For the experimental procedure, the participants will be asked to stand upright with their arms by their sides. Postural sway will be initially assessed in a normal clinic room in 1 of the 8 standing test conditions (4 different standing conditions: (1) feet shoulder wide apart, (2) feet together, (3) tandem position (4) on foam with shoulder wide apart and 2 different visual conditions: (1) eyes open, (2) eyes closed).	8 weeks