The Effectiveness of a Dual-task Training Program

NCT ID: NCT06450119

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2025-12-31

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.

Conditions

Frailty; Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

dual-task training

walking and cognition training

Group Type: EXPERIMENTAL

walking training

Intervention Type: OTHER

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

cognition training

Intervention Type: OTHER

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

walking training alone

walking training

Group Type: ACTIVE_COMPARATOR

walking training

Intervention Type: OTHER

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

cognition training alone

cognition training

Group Type: ACTIVE_COMPARATOR

cognition training

Intervention Type: OTHER

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

waiting list group

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

walking training

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

Intervention Type: OTHER

cognition training

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Huang, Hui-Chuan

Professor, School of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui-Chuan Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Central Contacts

Hui-Chuan Huang, PhD

Role: CONTACT

huichuan@tmu.edu.tw

886-2-27361661 ext. 6349

Other Identifiers

N202304115

Identifier Type: -

Identifier Source: org_study_id