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The Effectiveness of a Dual-task Training Program

The Improvement of Cognition and Physical Function in Middle-aged and Older Adults With Cognitive Frailty: the Effectiveness of a Dual-task Training Program

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06450119
Enrollment
196
Registered
2024-06-10
Start date
2024-06-03
Completion date
2025-12-31
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Cognitive Decline

Keywords

Cognitive frailty, Cognition, Dual-task training, Frailty

Brief summary

The purpose of this study is to explore the effect of a dual-task training intervention on cognitive function,physical function, depression symptoms and quality of life in middle-aged and elderly people with cognitive impairment. A Randomized experimental research design is conduced to recruited 196 middle-aged and elderly people: potentially reversible or reversible cognitive decline to attend this study. All participants are randomly allocated into dual-task training, walking training alone, and cognitive training alone and the waiting list control group. The measurements include: demographic and disease data, frailty symptoms (The FRAIL Scale ,Time up and go test ,Sit-to-stand test), cognitive function (Montreal Cognitive Assessment Scale Chinese version), depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale) and life Quality (Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire). The results of the study will use Generalized Liner Models and Pearson's product difference correlation analysis to confirm the impact of dual task training intervention on physical function, cognitive function, and depressive symptoms in middle-aged and elderly people with cognitive impairment effect on quality of life.

Detailed description

A Randomized experimental research design is conduced to recruited 196 middle-aged and elderly people: potentially reversible or reversible cognitive decline to attend this study. All participants are randomly allocated into dual-task training, walking training alone, and cognitive training alone and the waiting list control group. The dual task training group will receive 12 weeks of walking and cognitive training. The walking training alone group will receive 12 wees of walking training. The cognitive training alone group will receive 12 weeks of cognitive training. Each session is 60 minutes and twice a week. The waiting list control group will not receive intervention activities. Outcomes are measured both before and after the intervention. The measurements include: demographic and disease data, frailty symptoms (The FRAIL Scale ,Time up and go test ,Sit-to-stand test), cognitive function (Montreal Cognitive Assessment Scale Chinese version), depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale) and life Quality (Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire). The results of the study will use Generalized Liner Models and Pearson's product difference correlation analysis to confirm the impact of the dual task training intervention on physical function, cognitive function, and depressive symptoms in middle-aged and elderly people with cognitive impairment effect on quality of life.

Interventions

The walking training alone group would receive walking training for 60 minutes twice weekly for twelve weeks.

The cognition training alone group would receive cognition training for 60 minutes twice weekly for twelve weeks.

Sponsors

Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. age more than 50 years; 2. with physical frailty identified as The FRAIL Scale ≥1 3. subjective cognitive decline(subjective memory complain ≥3); 4. with literacy; 5. without regular exercise habits (\<150 minutes/weekly); 6. without receiving cognitive training

Exclusion criteria

1. incapable of walking independent; 2. with diagnosis of cancer, dementia,neurological diseases (e.g., stroke, head injury, and brain tumor), psychiatric disorders (e.g.,depression, bipolar, and schizophrenia), cardiac infraction,and hemodialysis.

Design outcomes

Primary

MeasureTime frameDescription
The FRAIL ScaleBaselineThe FRAIL scale (short five-questions assessment of fatigue, resistance, aerobic capacity, illnesses and loss of weight) classified the patients into three categories: robust (score=0), pre-frailty (score=1-2), and frailty (score=3-5)
Time up and go testBaselineThe Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls
Sit-to-stand testBaselineThe score is the total number of stands within 30 second.
cognitive function (Montreal Cognitive Assessment Scale Chinese version)BaselineMontreal Cognitive Assessment Scale Chinese version is a 30-point test that assesses nine cognitive domains (executive function, language, orientation, calculation, conceptual thinking, memory, visual perception, naming and attention). MoCA for MCI detection were 19 in the low-level education group (≤6 years), 22 in the mid-level education group (7-12 years) and 24 in the high-level education group (\>12 years), respectively.

Secondary

MeasureTime frameDescription
depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale)BaselineThe Chinese version of Clinical Depression Symptom Assessment Scale contains 18 items assessing all of the DSM-IV inclusion criteria for major depressive disorder as well as psychosocial impairment and quality of life.Total symptom scores on the scale range from 0 to 64. Empirically derived severity score ranges are 0-10 (nondepressed), 11-20 (minimal depression), 21-30 (mild depression), 31-45 (moderate depression), and 46-64 (severe depression).
quality of life ( Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire)BaselineThe Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire is a 28-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environmental health (9 items). Higher scores indicates good quality of life.

Contacts

Primary ContactHui-Chuan Huang, PhD
huichuan@tmu.edu.tw886-2-27361661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026