The Effectiveness of a Dual-task Training Program

June 6, 2024 updated by: Huang, Hui-Chuan, Taipei Medical University

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

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.

Study Overview

Status

Not yet recruiting

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.

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dual-task training
walking and cognition training
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.
Active Comparator: walking training alone
walking training
The walking training alone group would receive walking training for 60 minutes twice weekly for twelve weeks.
Active Comparator: cognition training alone
cognition training
The cognition training alone group would receive cognition training for 60 minutes twice weekly for twelve weeks.
No Intervention: waiting list group
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The FRAIL Scale
Time Frame: Baseline
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)
Baseline
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)
at 12 weeks after intervention
Time up and go test
Time Frame: Baseline
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
Baseline
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
at 12 weeks after intervention
Sit-to-stand test
Time Frame: Baseline
The score is the total number of stands within 30 second.
Baseline
Sit-to-stand test
Time Frame: at 12 weeks after intervention
The score is the total number of stands within 30 second.
at 12 weeks after intervention
cognitive function (Montreal Cognitive Assessment Scale Chinese version)
Time Frame: Baseline
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.
Baseline
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.
at 12 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale)
Time Frame: Baseline
The 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).
Baseline
depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale)
Time Frame: at 12 weeks after intervention
The 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).
at 12 weeks after intervention
quality of life ( Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire)
Time Frame: Baseline
The 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.
Baseline
quality of life ( Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire)
Time Frame: at 12 weeks after intervention
TheTaiwan'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.
at 12 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hui-Chuan Huang, PhD, Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 3, 2024

Primary Completion (Estimated)

June 3, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 2, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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