Dual-Task Training for People With Mild Cognitive Impairment and Mild Dementia

NCT06348810 | Not Yet Recruiting

• 1 other identifier: DTT2024
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Evidence shows that people with dementia have a higher prevalence of sleep disturbance, cognitive decline, behavioral disturbance, and experience motor dysfunction. These symptoms are interrelated. However, few randomized controlled trial (RCT) studies implement dual-task training for mild cognitive impairment and mild dementia, especially for those who experience sleep problems and behavioral disturbances. Therefore, this study aims to analyze the effect of dual-task training in improving global cognitive function, executive function, working memory, sleep, behavioral disturbances, balance, and flexibility among people with mild cognitive impairment and mild dementia. The main questions it aims to answer are:

1. 1.. Does dual-task training affect primary outcomes (global cognitive function, executive function, and working memory)
2. 2.. Does dual-task training affect secondary outcomes (including sleep quality, behavioral disturbances, balance, and flexibility) for people with mild cognitive impairment and mild dementia?"

Conditions

Dementia; Mild Cognitive Impairment; Older Adult

Keywords

dual-task training; Dementia; Mild Cognitive Impairment; Older adult; Sleep quality; behavioral disturbance; cognition; balance; flexibility

Outcome Measures

Primary Outcomes (3)

• Global cognitive function

  measured using MMSE that consists of five domains including orientation to time (5 points), orientation to place (5 points), registration (3 points), attention and calculation (5 points), recall (3 points), and language (9 points), ranges from 0 to 30. MMSE 0-17 scores indicating severe cognitive impairment, 18-23 mild cognitive impairment, and 24-30 as normal (no cognitive impairment).

  baseline, week 6, week 12, week 16

• Executive function

  measured with the Wisconsin card sort test (WCST). The result of the test is then categorized including: 1). number of completed categories (NCC), 2). total number of errors, 3). perseverative response (PR), 4). perseverative errors, 5). non-perseverative errors (NEs), 6). conceptual level responses (CLRs), 7). failure to maintain set, and 8). trials to complete the first category

  baseline, week 6, week 12, week 16

• Working memory

  measured using a Digit span (DS) test that comprises both digit forward (16 points) and digit backward (14 points). In the DS forward, the participant had to listen to a digit span that kept to the speed of one digit per second and repeat it forward. In contrast, to DS forward, in the DS backward, the participant had to listen and repeat the span backward. Span was taken as the maximum length if performed without error. However, if participants answered wrong 2 times consequently, the task ended and the number of correct answers was calculated as a score

  baseline, week 6, week 12, week 16

Secondary Outcomes (4)

• Sleep Quality

  baseline, week 6, week 12, week 16

• Behavioral disturbance

  baseline, week 6, week 12, week 16

• Balance

  baseline, week 6, week 12, week 16

• Flexibility

  baseline, week 6, week 12, week 16

Study Arms (4)

Dual-task training

EXPERIMENTAL

Participants in the experimental group will receive dual-task training, which consists of cognitive and motor task carried out at the same time. The length of therapy is 12 weeks; sessions are 3 times per week, each session lasts 45 minutes, and total sessions are 36.

Behavioral: Dual-task training

Cognitive training

EXPERIMENTAL

Participants in this group receive cognitive training only. The length of therapy is 12 weeks; sessions are 3 times per week, each session lasts 45 minutes, and total sessions are 36.

Behavioral: Cognitive training

Motor training

EXPERIMENTAL

Participants in this group receive motor training only. The length of therapy is 12 weeks; sessions are 3 times per week, each session lasts 45 minutes, and total sessions are 36.

Behavioral: Motor training

Usual

ACTIVE COMPARATOR

Participants in this group receive usual care provided by the nursing home staff, which typically includes assistance with activities of daily living, medication management, and social activities. They do not receive the structured physical exercise program.

Other: Usual care

Interventions

Dual-task training BEHAVIORAL

The dual-task training is a combination of cognitive tasks and motor tasks which is done simultaneously or at the same time.

Also known as: combination of motor and cognitive task

Dual-task training

Cognitive training BEHAVIORAL

Participants only receive cognitive tasks

Cognitive training

Motor training BEHAVIORAL

Participants only receive motor tasks

Motor training

Usual care OTHER

assist participants with activities of daily living, medication management, and social activities (such as singing, watching television).

Also known as: Routine care

Usual

Eligibility Criteria

• Age: 60 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adult \>= 60 years and able to communicate
• CDR score range from 1 to 4
• MMSE score \>= 18
• Complain of conscious cognitive decline.
• Participate voluntarily and sign informed consent.

You may not qualify if:

• Diagnosed with moderate or severe dementia.
• Received cognitive training or motor training within six months.
• Severe sensory function impairment (such as vision, and hearing).
• Have limited mobility, such as those using wheelchairs or four-legged walking aids.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Nursing Home

Malang, East Java, 65216, Indonesia

Location

Related Publications (10)

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  PMID: 12547745 RESULT

• Abbas-Zadeh M, Hossein-Zadeh GA, Vaziri-Pashkam M. Dual-Task Interference in a Simulated Driving Environment: Serial or Parallel Processing? Front Psychol. 2021 Jan 12;11:579876. doi: 10.3389/fpsyg.2020.579876. eCollection 2020.

  PMID: 33584415 RESULT

• Ambrogio F, Martella LA, Odetti P, Monacelli F. Behavioral Disturbances in Dementia and Beyond: Time for a New Conceptual Frame? Int J Mol Sci. 2019 Jul 25;20(15):3647. doi: 10.3390/ijms20153647.

  PMID: 31349706 RESULT

• Bayot M, Dujardin K, Tard C, Defebvre L, Bonnet CT, Allart E, Delval A. The interaction between cognition and motor control: A theoretical framework for dual-task interference effects on posture, gait initiation, gait and turning. Neurophysiol Clin. 2018 Dec;48(6):361-375. doi: 10.1016/j.neucli.2018.10.003. Epub 2018 Oct 26.

  PMID: 30487064 RESULT

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 RESULT

• Chiu HL, Chan PT, Kao CC, Chu H, Chang PC, Hsiao SS, Liu D, Chang WC, Chou KR. Effectiveness of executive function training on mental set shifting, working memory and inhibition in healthy older adults: A double-blind randomized controlled trials. J Adv Nurs. 2018 May;74(5):1099-1113. doi: 10.1111/jan.13519. Epub 2018 Jan 24.

  PMID: 29288507 RESULT

• Kuan YC, Huang LK, Wang YH, Hu CJ, Tseng IJ, Chen HC, Lin LF. Balance and gait performance in older adults with early-stage cognitive impairment. Eur J Phys Rehabil Med. 2021 Aug;57(4):560-567. doi: 10.23736/S1973-9087.20.06550-8. Epub 2020 Dec 1.

  PMID: 33258361 RESULT

• Tzeng RC, Yang YW, Hsu KC, Chang HT, Chiu PY. Sum of boxes of the clinical dementia rating scale highly predicts conversion or reversion in predementia stages. Front Aging Neurosci. 2022 Sep 23;14:1021792. doi: 10.3389/fnagi.2022.1021792. eCollection 2022.

  PMID: 36212036 RESULT

• Yang HL, Chu H, Kao CC, Chiu HL, Tseng IJ, Tseng P, Chou KR. Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. Age Ageing. 2019 Jul 1;48(4):519-525. doi: 10.1093/ageing/afz029.

  PMID: 30989165 RESULT

• Musa G, Henriquez F, Munoz-Neira C, Delgado C, Lillo P, Slachevsky A. Utility of the Neuropsychiatric Inventory Questionnaire (NPI-Q) in the assessment of a sample of patients with Alzheimer's disease in Chile. Dement Neuropsychol. 2017 Apr-Jun;11(2):129-136. doi: 10.1590/1980-57642016dn11-020005.

  PMID: 29213504 RESULT

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders; Mental Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nur Aini, MSc

  School of Nursing, College of Nursing, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nur Aini, MSc

CONTACT

+6285234727354; d432110003@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will be blind, so they didnt know which is intervention group or control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: eksperimental group receive dual-task training, while control group receive usual care and both conduct at the same time

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 5, 2024
• Study Start: July 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

ID (1)