FrailtyNCT06450119
The Effectiveness of a Dual-task Training Program
A study testing walking training and cognition training in people with Frailty and Cognitive Decline, run by Taipei Medical University.
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Frailty, Cognitive Decline
- What is being tested?
- walking training and cognition training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- walking training, cognition training
- Keywords
- Cognitive frailty, Cognition, Dual-task training, Frailty
- Medical subject headings
- Frailty, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking trainingOther
The walking training alone group would receive walking training for 60 minutes twice weekly for twelve weeks.
cognition trainingOther
The cognition training alone group would receive cognition training for 60 minutes twice weekly for twelve weeks.
| Study group | Role | What they receive |
|---|---|---|
| dual-task training | Experimental | walking and cognition training Receives: Other: walking training; Other: cognition training |
| walking training alone | Active comparator | walking training Receives: Other: walking training |
| cognition training alone | Active comparator | cognition training Receives: Other: cognition training |
| waiting list group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: at 12 weeks after intervention
Sit-to-stand test
The score is the total number of stands within 30 second.
Measured: Baseline
Sit-to-stand test
The score is the total number of stands within 30 second.
Measured: 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.
Measured: 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.
Measured: at 12 weeks after intervention
Secondary outcomes (4)
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).
Measured: Baseline
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).
Measured: at 12 weeks after intervention
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.
Measured: Baseline
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.
Measured: at 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start3 Jun 2024 (estimated)
- Primary completion3 Jun 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang, Hui-Chuan, Taipei Medical University
- Investigators
- Hui-Chuan Huang, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450119
- Sponsor's protocol ID
- N202304115
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06450119
- Acronym / sponsor ID
- N202304115
- Conditions
- Frailty, Cognitive Decline
- Keywords
- Cognitive frailty, Cognition, Dual-task training, Frailty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 3 Jun 2024 (estimated)
- Primary completion
- 3 Jun 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| dual-task training | Experimental | Other: walking training, Other: cognition trainingwalking and cognition training |
| walking training alone | Active comparator | Other: walking trainingwalking training |
| cognition training alone | Active comparator | Other: cognition trainingcognition training |
| waiting list group | No intervention | –no intervention |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking trainingThe walking training alone group would receive walking training for 60 minutes twice weekly for twelve weeks. | Other | dual-task training, walking training alone |
| cognition trainingThe cognition training alone group would receive cognition training for 60 minutes twice weekly for twelve weeks. | Other | cognition training alone, dual-task training |
Primary outcome
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)
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)
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
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
Sit-to-stand test
Time frame: Baseline
The score is the total number of stands within 30 second.
Sit-to-stand test
Time frame: at 12 weeks after intervention
The score is the total number of stands within 30 second.
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.
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.
4 secondary outcomes
depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale)
Time frame: Baseline
depressive symptoms (Chinese version of Clinical Depression Symptom Assessment Scale)
Time frame: at 12 weeks after intervention
quality of life ( Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire)
Time frame: Baseline
quality of life ( Taiwan's simplified version of the World Health Organization Quality of Life Questionnaire)
Time frame: at 12 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
Related trials for Frailty
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Recruiting
The VICTORY Trial: Virtual, Innovative, Postsurgical Care To Optimize Return Home for Older People With frailtY
Surgery, Frailty
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Chuan Huang, PhD principal investigator
Taipei Medical University
Questions about this trial
What is this clinical trial studying?
A study testing walking training and cognition training in people with Frailty and Cognitive Decline, run by Taipei Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Chuan Huang, PhD (886-2-27361661 ext. 6349, huichuan@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The FRAIL Scale (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.