An interventional study of Integrated Dual-Task Training and Sequential Dual-Task Training in Mild Cognitive Impairment (MCI) and Moderate Cognitive Impairment, sponsored by Shifa Tameer-e-Millat University. Recruiting at 1 site in Pakistan. Open to participants aged 55 Months to 85 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Shifa Tameer-e-Millat University · Not applicable, Interventional, and Treatment
Mild and Moderate cognitive impairment is a condition characterized by a noticeable decline in cognitive abilities, including memory and thinking skills, which is greater than expected for an individual's age but does not significantly interfere with daily life. Early intervention is essential to prevent further cognitive decline and progression to dementia.
Dual-task training has emerged as an effective rehabilitation approach that combines cognitive and motor tasks to enhance neuroplasticity and improve both physical and cognitive performance. This study is designed to investigate the effectiveness of dual-task training compared to conventional therapy in individuals with mild cognitive impairment.
Participants meeting the inclusion criteria will be recruited and randomly allocated into intervention and control groups. The intervention group will receive structured dual-task training, which may include activities such as walking while performing cognitive tasks (e.g., counting, word recall), balance exercises combined with mental tasks, and functional activities requiring divided attention. The control group will receive standard rehabilitation or single-task training.
The intervention will be conducted over a specified duration (e.g., several weeks), with sessions held multiple times per week. Outcome measures will be assessed at baseline and after completion of the intervention. The primary outcome will be cognitive function measured using the Mini-Mental State Examination (MMSE). Secondary outcomes may include balance, mobility, and functional performance.
Data will be analyzed to determine the effectiveness of dual-task training in improving cognitive and functional outcomes. The results of this study may contribute to evidence-based rehabilitation practices and support the use of dual-task interventions in clinical settings.
The elderly population is rapidly growing as a result of the global increase in life expectancy, and age-related cognitive disorders are becoming more common. Dementia has become a major public health concern that greatly contributes to disability, dependence, and a lower quality of life among older adults worldwide It is commonly acknowledged that mild cognitive impairment (MCI) is a stage that lies between dementia and normal cognitive aging. While independence in the most fundamental aspects of daily life is largely maintained, it is characterized by an apparent decline in cognitive abilities, especially memory and executive functions, early intervention is crucial because people with MCI continue to have an elevated risk of developing Alzheimer's disease Physical decline, such as decreased gait speed, balance issues, muscle weakness, and a high risk of falls, is often associated with cognitive impairment in elderly individuals. Since shared neural pathways support both motor and cognitive functions, these physical impairments are closely associated with cognitive dysfunction Elderly people's functional independence and quality of life are severely compromised when cognitive decline and physical decline coexist Pharmacological treatments for dementia and cognitive impairment provide only slight symptom relief and are ineffective at stopping the progression of the disease, despite advancements in medical management. Because of this restriction, research attention is now more focused on non-pharmacological strategies to improve functional outcomes and postpone cognitive decline Given their ability to address both cognitive and motor deficits at the same time, combined cognitive and physical training approaches have drawn more attention in this context One effective rehabilitation technique is dual-task training, which involves performing cognitive and motor tasks simultaneously or sequentially. This method places significant demands on attentional control and executive functioning and reflects functional demands found in real life, such as walking while completing a cognitive task. Dual-task training increases prefrontal cortical activation, boosts neural efficiency, and encourages neuroplastic adaptations that support cognitive and motor function, according to neurophysiological evidence There are two main ways to deliver motor-cognitive training: sequential (successive) dual-task training and integrated (simultaneous) dual-task training. The simultaneous performance of cognitive and motor tasks is necessary for integrated training, which may improve executive control by increasing cognitive-motor interference. By using different learning mechanisms, sequential training, on the other hand, enables concentrated attention to each task and may promote neural consolidation and task automation Even though both strategies have shown positive results, the research so far has produced inconsistent findings about how effective they are in comparison, especially when it comes to older people with various levels of cognitive impairment. Furthermore, there aren't many carefully planned multi-arm randomized controlled trials that compare integrated and sequential dual-task training in groups of people with mild to moderate cognitive impairment.
Therefore, the current study uses a four-arm randomized controlled trial design to compare the effects of integrated versus sequential dual-task training in senior citizen with mild to moderate cognitive impairment. This study aims to determine the best intervention approach for strengthening cognitive function, increasing mobility, and encouraging functional independence in this expanding and vulnerable population by assessing cognitive, physical, and functional outcomes.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 96 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Shifa Tameer-e-Millat University is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with mild cognitive impairment will receive integrated dual-task training, where motor and cognitive tasks are performed simultaneously. Training will be conducted for 8 weeks, 3 sessions per week, each lasting 45 minutes.
Behavioral: Integrated Dual-Task Training
Participants with moderate cognitive impairment will receive integrated dual-task training combining simultaneous motor and cognitive tasks. The intervention will last 8 weeks, with 3 sessions per week of 45 minutes each.
Behavioral: Integrated Dual-Task Training
Participants with mild cognitive impairment will undergo sequential dual-task training, where motor and cognitive tasks are performed separately. Training will be conducted over 8 weeks, 3 sessions per week, 45 minutes per session.
Behavioral: Sequential Dual-Task Training
Participants with moderate cognitive impairment will receive sequential dual-task training, involving separate motor and cognitive task performance. The program duration is 8 weeks, with 3 weekly sessions of 45 minutes each.
Behavioral: Sequential Dual-Task Training
Participants will perform motor and cognitive tasks simultaneously (integrated dual-task training). The intervention includes balance and gait exercises combined with cognitive activities such as counting, memory, and executive function tasks. Training will be conducted for 8 weeks, 3 sessions per week, with each session lasting 45 minutes.
Participants will perform motor and cognitive tasks separately (sequential dual-task training). Motor exercises (balance, gait training) and cognitive tasks (memory, attention, executive function) will be administered in sequence. The intervention will last 8 weeks, with 3 sessions per week, each session lasting 45 minutes.
Functional Mobility (Timed Up and Go Test) Change from Baseline in Timed Up and Go (TUG) Test Time at 8 Weeks
Functional mobility will be evaluated using the Timed Up and Go (TUG) test. It measures the time (in seconds) taken by a participant to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Lower times indicate better mobility. Functional mobility and balance will be assessed using the Timed Up and Go (TUG) test, a simple and widely used clinical measure of mobility and fall risk. In this test, participants are required to stand up from a standard chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down. The total time taken to complete the task is recorded in seconds. Shorter completion times indicate better functional mobility and balance, while longer times indicate impaired mobility and increased risk of falls. A time of less than 10 seconds is considered normal for healthy adults, 10-19 seconds indicates good mobility, 20-29 seconds suggests variable mobility, and 30 seconds or more indicates impaired mobility and a higher risk of falls
Time frame: Baseline and after 8 weeks of intervention
Executive Function (Trail Making Test) Change from Baseline in Trail Making Test (Part A and Part B) Completion Time at 8 Weeks
Executive function will be assessed using the Trail Making Test (TMT Parts A and B), which evaluates cognitive flexibility, processing speed, and task-switching ability. Performance is measured by completion time in seconds. Cognitive function, specifically attention, processing speed, and executive function, will be assessed using the Trail Making Test (TMT). The test consists of two parts: Part A and Part B. In Part A, participants are required to connect numbered dots in sequential order as quickly as possible, assessing visual scanning and processing speed. In Part B, participants alternate between numbers and letters in sequence (e.g., 1-A-2-B), assessing executive function and task-switching ability. The outcome is measured as the time (in seconds) taken to complete each part. Longer completion times indicate poorer cognitive performance, while shorter times indicate better cognitive performance. The Trail Making Test will be administered at baseline and after completion of the
Time frame: Baseline and after 8 weeks of intervention
Global Cognitive Function (Montreal Cognitive Assessment) Change from Baseline in Montreal Cognitive Assessment (MoCA) Score at 8 Weeks
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). It evaluates multiple cognitive domains including attention, memory, language, visuospatial ability, and executive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a standardized screening tool designed to detect mild cognitive impairment. The MoCA evaluates multiple cognitive domains including attention, executive function, memory, language, visuospatial skills, abstraction, calculation, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance and lower scores indicating greater cognitive impairment. A score of 26 or above is generally considered normal cognitive function. The MoCA will be administered at baseline and after completion of the intervention period to assess changes in cognitive function.
Time frame: Baseline and after 8 weeks of intervention
Balance Performance (Berg Balance Scale) Change from Baseline in Berg Balance Scale (BBS) Score at 8 Weeks
Balance will be assessed using the Berg Balance Scale (BBS), a 14-item objective measure designed to assess static and dynamic balance abilities in older adults. Scores range from 0 to 56, with higher scores indicating better balance performance. Balance will be assessed using the Berg Balance Scale (BBS), a standardized clinical tool used to evaluate static and dynamic balance abilities. The BBS consists of 14 functional tasks, including sitting, standing, transferring, reaching, turning, and single-leg stance. Each item is scored on a 5-point scale ranging from 0 to 4, with a maximum total score of 56. Higher scores indicate better balance performance, while lower scores indicate greater balance impairment and increased risk of falls. A score of 41-56 indicates low fall risk, 21-40 indicates medium fall risk, and 0-20 indicates high fall risk. The BBS will be administered at baseline and after completion of the intervention period to assess changes in balance performance.
Time frame: Baseline and after 8 weeks of intervention
Cognitive Function (Mini-Mental State Examination) Change from Baseline in Mini-Mental State Examination (MMSE) Score at 8 Weeks
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE), a widely used screening tool for cognitive impairment. The MMSE evaluates domains including orientation, registration, attention and calculation, recall, and language. Scores range from 0 to 30, with higher scores indicating better cognitive function. Cognitive function will be assessed using the Mini-Mental State Examination (MMSE), a widely used standardized tool for evaluating cognitive impairment. The MMSE assesses domains including orientation, registration, attention and calculation, recall, language, and visuospatial ability. The total score ranges from 0 to 30, with higher scores indicating better cognitive function and lower scores indicating greater cognitive impairment. A score of 24-30 is generally considered normal cognition, 18-23 indicates mild cognitive impairment, and 0-17 indicates severe cognitive impairment. MMSE will be administered at baseline and after completion
Time frame: Baseline and after 8 weeks of intervention
Quality of Life Change from Baseline in WHO Quality of Life-BREF (WHOQOL-BREF) Score at 6 Weeks
Quality of life will be measured using the WHOQOL-BREF questionnaire, which assesses physical health, psychological health, social relationships, and environmental domains. Higher scores indicate better quality of life. Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire, a standardized instrument that evaluates individuals' perception of their position in life in the context of culture and value systems. The WHOQOL-BREF consists of 26 items covering four domains: physical health, psychological health, social relationships, and environmental well-being. Each item is scored on a 5-point Likert scale, and domain scores are transformed to a scale of 0 to 100, with higher scores indicating better quality of life. The WHOQOL-BREF will be administered at baseline and after completion of the intervention period to assess changes in quality of life.
Time frame: Baseline and after 8 weeks of intervention
Plan to share: No — Individual participant data will not be shared due to privacy and confidentiality concerns, as well as limited resources for data management and sharing.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Aug 2026, 2 months after the start.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 2 months is below that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
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Shifa Tameer-e-Millat University