Clinical trial NCT06450119: The Effectiveness of a Dual-task Training Program
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty
Cognitive Decline
Keywords: Cognitive frailty, Cognition, Dual-task training, Frailty
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 196
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The FRAIL Scale
timeFrame: Baseline
measure: The FRAIL Scale
timeFrame: at 12 weeks after intervention
measure: Time up and go test
timeFrame: Baseline
measure: Time up and go test
timeFrame: at 12 weeks after intervention
measure: Sit-to-stand test
timeFrame: Baseline
measure: Sit-to-stand test
timeFrame: at 12 weeks after intervention
measure: cognitive function (Montreal Cognitive Assessment Scale Chinese version)
timeFrame: Baseline
measure: cognitive function (Montreal Cognitive Assessment Scale Chinese version)
timeFrame: at 12 weeks after intervention
Secondary outcomes:
measure: depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale)
timeFrame: Baseline
measure: depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale)
timeFrame: at 12 weeks after intervention
measure: quality of life ( Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire)
timeFrame: Baseline
measure: quality of life ( Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire)
timeFrame: at 12 weeks after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University
name: Hui-Chuan Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: