Elderly AdultsNCT05537363
Agility Training and Its Relations in Elderly Adults With and Without MCI
A study testing Health education, Multicomponent training and Agility training in people with Elderly Adults and Mild Cognitive Impairment, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The following three-part proposal will focus on the effects of agility training as well as the relationship between agility ability and motor and cognitive function, and risk of falls in elderly adults with or without mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly Adults, Mild Cognitive Impairment, Healthy
- What is being tested?
- Health education, Multicomponent training and Agility training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Sep 2022to 13 Mar 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 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- has a score of ≥ 24 on the Mini-Mental State Examination (MMSE)
- able to walk independently for more than 30 meters without assistive aids
- able to follow orders
- older than 65 years old
- score of Mini-Mental State Examination (MMSE) ≥ 24 and score of Montreal Cognitive Assessment (MoCA) ≤ 26
- able to walk independently for more than 30 meters without assistive aids
Show all 11Show fewer
- able to follow orders
- older than 65 years old
- score of Mini-Mental State Examination (MMSE) ≥ 24
- able to walk independently for more than 30 meters without assistive aids
- able to follow orders
Who cannot join
- poorly-controlled or unstable systematic disease
- has a history of central nervous system disease
- currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain
- subjects with achromatopsia
- Part 2:
- poorly controlled or unstable systematic disease
Show all 16Show fewer
- has a history of central nervous system disease
- currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain
- has other medical conditions for which exercise is contraindicated
- subjects with achromatopsia
- Part 3:
- poorly controlled or unstable systematic disease
- has a history of central nervous system disease
- currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain
- has other medical conditions for which exercise is contraindicated
- subjects with achromatopsia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of an Agility Training and Its Relation to Motor, Cognitive Performance and Fall Risk in Elderly Adults With and Without Mild Cognitive Impairment
The following three-part proposal will focus on the effects of agility training as well as the relationship between agility ability and motor and cognitive function, and risk of falls in elderly adults with or without mild cognitive impairment (MCI).
Part I is a cross-sectional study design that will assess the level of agility in healthy young adults, healthy elderly adults, and elderly adults with MCI to determine the effect of aging and cognition decline on agility and the relations between agility, cognitive, and motor functions. Thirty participants will be screened for eligibility and recruited for each group (90 participants total). After collecting basic data, all participants will undergo cognitive and motor function tests, as well as an agility test. Cognitive function tests include tests of global cognition, working memory, mental set shifting, and selective attention. Motor function tests include tests of single and dual task walking, strength, power, balance, flexibility, and endurance. The agility test contains stop-and-go, change of direction, and spatial orientation components. Functional near-infrared spectroscopy (fNIRS) will be used to evaluate the brain activation during the agility test, cognitive tests, and single and dual task walking. Results from all tests will be used to determine the motor, cognitive, and other predictive factors associated with agility performance, and will be used in the design of the training program in Part II and III.
Part II and III are single-blinded randomized controlled trials that will explore the short and long-term effects of a multicomponent training and an agility training protocol on agility, motor, and cognitive function in elderly adults with and without MCI. Seventy-five elderly adults with MCI (Part II) and seventy-five healthy elderly (Part III) will be recruited. After screening for eligibility and collection of demographic data, participants will undergo a pretest assessment. In addition to the motor, cognitive, and agility tests used in Part I, information on history of falls, falls efficacy, and quality of life will be assessed for each participant. Brain activation will be assessed during the agility test, cognitive tests, and single and dual task walking assessments using fNIRS. Participants will be randomly allocated into one of three groups: the control group, the multicomponent training group, or the agility training group (n=25 in each group). Intervention will be executed at a frequency of 45 minutes per session, 2 times a week for 8 weeks. The control group will receive home-based health education guidelines. The multicomponent training group will engage in 3 to 4 exercises each training session comprising the influencing factors of agility, and the agility training group will engage in integrated task-specific training. A post-test will be conducted after the 8-week intervention, and 1-month, 6-month, and 12-month follow-ups will be conducted for elderly adults with MCI. The healthy elderly adults will be assessed after the intervention and at the 1-month follow-up after training.
- Conditions
- Elderly Adults, Mild Cognitive Impairment, Healthy
- Being tested
- Health education, Multicomponent training, Agility training
- Keywords
- Aging, Agility training, Cognition function, Fall, Mild Cognitive Impairment, Motor function
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationOther
Participants in the control group will receive health educational guidelines. Guideline contents include home-based exercise program, nutrition recommendations, and fall prevention education.
Multicomponent trainingOther
Multicomponent exercises will be designed according to the results of Part I of our study. Results of Part I of this study will determine the contributing factors of agility, such as muscle strength, endurance, and cognitive function. A physical therapist will train the participants 3-4 exercises (3-4 factors) in each session. The physical therapist will adjust the difficulty of each exercise according to the participant's ability and condition.
Agility trainingOther
The agility-based task-specific exercises will be conducted in this group and will incorporate stop-and-go, change in direction, change in velocity, acceleration and deceleration training. There are four training configurations with 3 levels of difficulty, which will be manipulated by increasing speed, distance, number of repetitions, number of directions, congruency, and/or complexity of the task, or by decreasing the number and duration of the rest intervals. The physical therapist will adjust the difficulty of each exercise according to the participant's ability and condition.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | No intervention | Year 1: To assess levels of agility and agility performance in relation to the motor and cognitive abilities of healthy young adults, healthy elderly, and elderly with MCI. |
| Healthy elderly and mild cognitive impairment elderly | No intervention | Year 1: To assess levels of agility and agility performance in relation to the motor and cognitive abilities of healthy young adults, healthy elderly, and elderly with MCI. |
| Mild cognitive impairment elderly with health education | Active comparator | Year 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI. Receives: Other: Health education |
| Mild cognitive impairment elderly with multicomponent training | Experimental | Year 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI. Receives: Other: Multicomponent training |
| Mild cognitive impairment elderly with agility training | Experimental | Year 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI. Receives: Other: Agility training |
| Healthy elderly with health education | Active comparator | Year 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults. Receives: Other: Health education |
| Healthy elderly with multicomponent training | Experimental | Year 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults. Receives: Other: Multicomponent training |
| Healthy elderly with agility training | Experimental | Year 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults. Receives: Other: Agility training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agility Challenge for the Elderly (ACE)
An agility course developed for a 9m x 18m volleyball court and includes three segments that each aim to test a specific aspect of agility, including stop-and-go, change of direction, and spatial orientation.
Measured: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Secondary outcomes (8)
Fall history and fear of falls
Fall history will be recorded by the number of fall episodes in the past 6 months and whether it caused injury.
Measured: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Quality of life (QOL)
Quality of life (QOL) will be evaluated by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36).
Measured: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Brain activation
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) will be used to detect the hemodynamics of brain areas associated with the agility test, cognitive tasks, and single and dual task walking test.
Measured: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Montreal Cognitive Assessment (MoCA)
MoCA contains 16 items and 11 categories to assess multiple cognitive domains, is a screening instrument for MCI, and its validity has been established in various clinical groups and countries.
Measured: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Mental set shifting
The Wisconsin Card Sorting Test (WCST) will be used to measure participants' ability to shift their cognitive ability in response to the demands of environment.
Measured: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Working memory
The backward digit span test (DGS) will be used to measure working memory.
Measured: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Selective attention and inhibition
The Stroop Color and Word Test (SCWT) will be used to measure selective attention.
Measured: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Motor Function
Walking performance, normal walking, cognitive dual-task walking, muscle strength of bilateral lower limbs, five times sit to stand test, timed up and go, quiet static standing task, and the 360° turning task, flexibility, 6-minute walk test (6WMT).
Measured: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start28 Sep 2022
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly AdultsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Ci Liu, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537363
- Sponsor's protocol ID
- 202112236RINB
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2022
- Last updated
- 31 Aug 2026
- 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Agility Training and Its Relation to Motor, Cognitive Performance and Fall Risk in Elderly Adults With and Without Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05537363
- Acronym / sponsor ID
- 202112236RINB
- Conditions
- Elderly Adults, Mild Cognitive Impairment, Healthy
- Keywords
- Aging, Agility training, Cognition function, Fall, Mild Cognitive Impairment, Motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 13 Sep 2022 (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 following three-part proposal will focus on the effects of agility training as well as the relationship between agility ability and motor and cognitive function, and risk of falls in elderly adults with or without mild cognitive impairment (MCI).
Part I is a cross-sectional study design that will assess the level of agility in healthy young adults, healthy elderly adults, and elderly adults with MCI to determine the effect of aging and cognition decline on agility and the relations between agility, cognitive, and motor functions. Thirty participants will be screened for eligibility and recruited for each group (90 participants total). After collecting basic data, all participants will undergo cognitive and motor function tests, as well as an agility test. Cognitive function tests include tests of global cognition, working memory, mental set shifting, and selective attention. Motor function tests include tests of single and dual task walking, strength, power, balance, flexibility, and endurance. The agility test contains stop-and-go, change of direction, and spatial orientation components. Functional near-infrared spectroscopy (fNIRS) will be used to evaluate the brain activation during the agility test, cognitive tests, and single and dual task walking. Results from all tests will be used to determine the motor, cognitive, and other predictive factors associated with agility performance, and will be used in the design of the training program in Part II and III.
Part II and III are single-blinded randomized controlled trials that will explore the short and long-term effects of a multicomponent training and an agility training protocol on agility, motor, and cognitive function in elderly adults with and without MCI. Seventy-five elderly adults with MCI (Part II) and seventy-five healthy elderly (Part III) will be recruited. After screening for eligibility and collection of demographic data, participants will undergo a pretest assessment. In addition to the motor, cognitive, and agility tests used in Part I, information on history of falls, falls efficacy, and quality of life will be assessed for each participant. Brain activation will be assessed during the agility test, cognitive tests, and single and dual task walking assessments using fNIRS. Participants will be randomly allocated into one of three groups: the control group, the multicomponent training group, or the agility training group (n=25 in each group). Intervention will be executed at a frequency of 45 minutes per session, 2 times a week for 8 weeks. The control group will receive home-based health education guidelines. The multicomponent training group will engage in 3 to 4 exercises each training session comprising the influencing factors of agility, and the agility training group will engage in integrated task-specific training. A post-test will be conducted after the 8-week intervention, and 1-month, 6-month, and 12-month follow-ups will be conducted for elderly adults with MCI. The healthy elderly adults will be assessed after the intervention and at the 1-month follow-up after training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | No intervention | –Year 1: To assess levels of agility and agility performance in relation to the motor and cognitive abilities of healthy young adults, healthy elderly, and elderly with MCI. |
| Healthy elderly and mild cognitive impairment elderly | No intervention | –Year 1: To assess levels of agility and agility performance in relation to the motor and cognitive abilities of healthy young adults, healthy elderly, and elderly with MCI. |
| Mild cognitive impairment elderly with health education | Active comparator | Other: Health educationYear 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI. |
| Mild cognitive impairment elderly with multicomponent training | Experimental | Other: Multicomponent trainingYear 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI. |
| Mild cognitive impairment elderly with agility training | Experimental | Other: Agility trainingYear 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI. |
| Healthy elderly with health education | Active comparator | Other: Health educationYear 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults. |
| Healthy elderly with multicomponent training | Experimental | Other: Multicomponent trainingYear 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults. |
| Healthy elderly with agility training | Experimental | Other: Agility trainingYear 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- has a score of ≥ 24 on the Mini-Mental State Examination (MMSE)
- able to walk independently for more than 30 meters without assistive aids
- able to follow orders
- older than 65 years old
- score of Mini-Mental State Examination (MMSE) ≥ 24 and score of Montreal Cognitive Assessment (MoCA) ≤ 26
Key exclusion criteria (16 listed)
- poorly-controlled or unstable systematic disease
- has a history of central nervous system disease
- currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain
- subjects with achromatopsia
- poorly controlled or unstable systematic disease
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 |
|---|---|---|
| Health educationParticipants in the control group will receive health educational guidelines. Guideline contents include home-based exercise program, nutrition recommendations, and fall prevention education. | Other | Healthy elderly with health education, Mild cognitive impairment elderly with health education |
| Multicomponent trainingMulticomponent exercises will be designed according to the results of Part I of our study. Results of Part I of this study will determine the contributing factors of agility, such as muscle strength, endurance, and cognitive function. A physical therapist will train the participants 3-4 exercises (3-4 factors) in each session. The physical therapist will adjust the difficulty of each exercise according to the participant's ability and condition. | Other | Healthy elderly with multicomponent training, Mild cognitive impairment elderly with multicomponent training |
| Agility trainingThe agility-based task-specific exercises will be conducted in this group and will incorporate stop-and-go, change in direction, change in velocity, acceleration and deceleration training. There are four training configurations with 3 levels of difficulty, which will be manipulated by increasing speed, distance, number of repetitions, number of directions, congruency, and/or complexity of the task, or by decreasing the number and duration of the rest intervals. The physical therapist will adjust the difficulty of each exercise according to the participant's ability and condition. | Other | Healthy elderly with agility training, Mild cognitive impairment elderly with agility training |
Primary outcome
Agility Challenge for the Elderly (ACE)
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
An agility course developed for a 9m x 18m volleyball court and includes three segments that each aim to test a specific aspect of agility, including stop-and-go, change of direction, and spatial orientation.
8 secondary outcomes
Fall history and fear of falls
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Quality of life (QOL)
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Brain activation
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Montreal Cognitive Assessment (MoCA)
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Mental set shifting
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Working memory
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Selective attention and inhibition
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Motor Function
Time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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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.
Yan Ci Liu, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education, Multicomponent training and Agility training in people with Elderly Adults and Mild Cognitive Impairment, run by National Taiwan University Hospital at 1 site in Taiwan.
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 11 inclusion and 16 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: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agility Challenge for the Elderly (ACE) (time frame: Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month). 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 31 Aug 2026.