Clinical trial NCT04301960: Effects of Single and Dual Task Training in Individuals With Mild Cognitive Impairment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Single-task
Dual-task
Processing Speed
Cognitive Functions
Walking Speed
Balance Function
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Choice Stepping Reaction Time Test (CSRT)
timeFrame: 8 weeks
Secondary outcomes:
measure: Stroop Test
timeFrame: 8 weeks
measure: Verbal Fluency Test (VFT)
timeFrame: 8 weeks
measure: Serial Subtraction Test (SST)
timeFrame: 8 weeks
measure: 10 Meter Walking Test (10 MWT)
timeFrame: 8 weeks
measure: 10 Meter Walking Test with Verbal Fluency Test (10 MWT-VFT)
timeFrame: 8 weeks
measure: 10 Meter Walking Test with Serial Subtraction Test (10 MWT-SST)
timeFrame: 8 weeks
measure: Fullerton Advanced Balance (FAB) Scale
timeFrame: 8 weeks
measure: D+R Balance Application
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
state: Eyalet/Yerleşke
Study officials:
affiliation: Eastern Mediterranean University
name: Betül Fatma Bilgin, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University
name: Gözde İyigün, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.