The Effectiveness of a Dual-task Training Program

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450119
• Other study ID #: N202304115
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Taipei Medical University
• Contact: Hui-Chuan Huang, PhD
• Phone: 886-2-27361661
• Email: huichuan[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 196
• Est. completion date: December 31, 2025
• Est. primary completion date: June 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Frailty

Intervention

Other:
• walking training
The walking training alone group would receive walking training for 60 minutes twice weekly for twelve weeks.
• cognition training
The cognition training alone group would receive cognition training for 60 minutes twice weekly for twelve weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The FRAIL Scale	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
Primary	The FRAIL Scale	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
Primary	Time up and go test	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
Primary	Time up and go test	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
Primary	Sit-to-stand test	The score is the total number of stands within 30 second.	Baseline
Primary	Sit-to-stand test	The score is the total number of stands within 30 second.	at 12 weeks after intervention
Primary	cognitive function (Montreal Cognitive Assessment Scale Chinese version)	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
Primary	cognitive function (Montreal Cognitive Assessment Scale Chinese version)	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	depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale)	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
Secondary	depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale)	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
Secondary	quality of life ( Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire)	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
Secondary	quality of life ( Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire)	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