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Clinical Trials/NCT06450119
NCT06450119
Not yet recruiting
Not Applicable

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

Taipei Medical University0 sites196 target enrollmentJune 3, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
Taipei Medical University
Enrollment
196
Primary Endpoint
The FRAIL Scale
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 3, 2024
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Huang, Hui-Chuan

Professor, School of Nursing

Taipei Medical University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • incapable of walking independent;
  • 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.

Outcomes

Primary Outcomes

The FRAIL Scale

Time Frame: at 12 weeks after intervention

The 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)

Sit-to-stand test

Time Frame: at 12 weeks after intervention

The score is the total number of stands within 30 second.

Time up and go test

Time Frame: at 12 weeks after intervention

The 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

cognitive function (Montreal Cognitive Assessment Scale Chinese version)

Time Frame: at 12 weeks after intervention

Montreal 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 Outcomes

  • quality of life ( Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire)(at 12 weeks after intervention)
  • depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale)(at 12 weeks after intervention)

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