The Effectiveness of a Dual-task Training Program

NCT06450119 | Not Yet Recruiting

• 1 other identifier: N202304115
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Frailty; Cognitive Decline

Keywords

Cognitive frailty, Cognition, Dual-task training, Frailty

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• Sit-to-stand test

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

  Baseline

• Sit-to-stand test

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

  at 12 weeks after intervention

• 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

• 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 Outcomes (4)

• depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale)

  Baseline

• depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale)

  at 12 weeks after intervention

• quality of life ( Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire)

  Baseline

• quality of life ( Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire)

  at 12 weeks after intervention

Study Arms (4)

dual-task training

EXPERIMENTAL

walking and cognition training

Other: walking training; Other: cognition training

walking training alone

ACTIVE COMPARATOR

walking training

Other: walking training

cognition training alone

ACTIVE COMPARATOR

cognition training

Other: cognition training

waiting list group

NO INTERVENTION

no intervention

Interventions

walking training OTHER

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

dual-task training; walking training alone

cognition training OTHER

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

cognition training alone; dual-task training

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hui-Chuan Huang, PhD

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Chuan Huang, PhD

CONTACT

886-2-27361661; huichuan@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Nursing

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 10, 2024
• Study Start: June 3, 2024
• Primary Completion: June 3, 2024
• Study Completion: December 31, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-06