Cognitive ImpairmentNCT06572878
Evaluation of Cognitive and Physical Training on MCI Elders
A study testing Cognitive training, Physical training and Combined cognitive and physical training in people with Cognitive Impairment and Mild Cognitive Impairment, run by Taipei Medical University.
Trial summary
This study examines the impact of combining cognitive and physical training, recognizing that daily living often requires individuals to perform multiple tasks simultaneously. The inability to execute such dual movements can hinder daily functioning. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment, Mild Cognitive Impairment
- What is being tested?
- Cognitive training, Physical training and Combined cognitive and physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be aged 60 years or older and able to communicate in Mandarin or Taiwanese.
- Mild cognitive impairment, assessed using the Mini Mental State Examination (MMSE) with a score of 14≦MMSE≦25.
- Self-reported complaints of cognitive decline.
- In addition to the above criteria, participants must voluntarily agree to participate and sign an informed consent form.
Who cannot join
- Individuals with severe psychiatric disorders or behavioral problems, as assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) with (a) severity score ≥ 6 and caregiver distress score ≥ 7.
- Participants who have undergone other cognitive or activity training within the past six months.
- Individuals with sensory impairments, such as visual, auditory, or communication difficulties.
- People with mobility impairments, such as those who use wheelchairs or mobility aids.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Effect of Cognitive and Physical Training on Mild Cognitive Impairment Elder's Physical and Cognition Domain: A Clinical Trial.
This study examines the impact of combining cognitive and physical training, recognizing that daily living often requires individuals to perform multiple tasks simultaneously. The inability to execute such dual movements can hinder daily functioning.
The primary goal is to enhance the ability of individuals with mild cognitive impairment (MCI) to perform two tasks concurrently, focusing on both cognitive and physical aspects. This research aims to deepen our understanding of how multitasking affects patients' abilities and to develop effective intervention programs.
Read the detailed description
The World Health Organization has recognized cognitive impairment as a significant global health issue, encompassing a spectrum of conditions from mild cognitive impairment to various forms of dementia. These conditions are linked to heightened risks of disability and mortality. In the absence of suitable interventions, cognitive functions typically exhibit a gradual decline over time, driven by factors including aging, neurological disorders, traumatic brain injury, and substance abuse.
A thorough literature review indicates that cognitive and physical training can sustain cognitive or physical functions, contingent upon the specific training protocols implemented. Concurrent cognitive and physical training entails the simultaneous execution of multiple cognitive and motor activities, thereby maintaining dual functional control. This innovative training modality integrates motor and cognitive rehabilitation into a cohesive framework.
This clinical trial adopts a randomized controlled design, stratifying participants into four distinct groups: cognitive training, physical training, combined cognitive and physical training, and passive informational activities. The interventions will be administered with a frequency of three times per week over a 12-week period, incorporating task-specific training to enhance both motor and cognitive functions.
- Conditions
- Cognitive Impairment, Mild Cognitive Impairment
- Being tested
- Cognitive training, Physical training, Combined cognitive and physical training, Passive information activities
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingOther
Cognitive training will follow a group format, with each group consisting of 4-16 participants. Each group will be in a private, independent room for their training sessions and will not interact with participants from other groups. The cognitive training task components will specifically focus on attention, learning and memory, executive function, perceptual-motor skills, and language.
Physical trainingOther
Physical training will follow a group format, with each group consisting of 4-16 participants. Each group will be in a private, independent room for their training sessions and will not interact with participants from other groups. The physical training task components will specifically focus on strength, balance, agility, gait, low-volume aerobic, and flexibility.
Combined cognitive and physical trainingOther
Combined cognitive and physical training will follow a group format, with each group consisting of 4-16 participants. Each group will be in a private, independent room for their training sessions and will not interact with participants from other groups. The combined cognitive and physical training components will specifically focus on a single cognitive task and simultaneously handle a single physical task.
Passive information activitiesOther
In passive informational activities, which include a variety of puzzles, audiobooks, and diverse reading materials such as newspapers or listening to news content.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training | Experimental | Each participant will receive cognitive training for 45 minutes per session, three sessions per week, for 12 weeks. Receives: Other: Cognitive training |
| Physical training | Experimental | Each participant will receive physical training for 45 minutes per session, three sessions per week, for 12 weeks. Receives: Other: Physical training |
| Combined cognitive and physical training | Experimental | Each participant will receive combined cognitive and physical training for 45 minutes per session, three sessions per week, for 12 weeks. Receives: Other: Combined cognitive and physical training |
| Passive information activities | Active comparator | Each participant will engage in passive information activities for 45 minutes per session, three sessions per week, for 12 weeks. Receives: Other: Passive information activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination
The Mini-Mental State Examination (MMSE) is a standardized instrument for assessing overall cognitive function, where higher scores indicate better global cognition, with a total score ranging from 0 to 30. It is crucial to consider both age and education levels when interpreting the results.
Measured: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Wisconsin Card Sorting Test - Computer Version
The Wisconsin Card Sorting Test (WCST) is a standardized instrument for assessing executive function. Interpreting WCST results includes analyzing the total correct responses and total errors. The total correct responses indicate the number of correct matches made by the participant; a higher number of correct responses suggests better overall cognitive performance and the ability to learn and apply the rules. Conversely, a high number of errors can indicate difficulties in understanding or applying the sorting rules.
Measured: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Digit Span Test
A standardized instrument for assessing working memory.
Measured: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Shor-form Berg balance scale
The Short-Form Berg Balance Scale (SFBBS) is a streamlined assessment tool designed to evaluate an individual's balance and stability. Each item on the SFBBS is scored on a scale from 0 to 4, with 0 indicating the lowest level of function and 4 indicating the highest level of function. The scores for each item are summed to obtain a total score, which provides an overall measure of balance. The maximum possible score varies depending on the number of items included in the short form.
Measured: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Back scratch test
A flexibility test.
Measured: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Chair sit-and-reach test
A flexibility test.
Measured: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Grip and pinch strength
A standardized instrument " PABLO®" for assessing strength.
Measured: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Gait analysis
A standardized instrument " PABLO®" for assessing gait performance.
Measured: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Secondary outcomes (8)
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a standardized instrument for assessing sleep quality and disturbances over a 1-month period. It evaluates seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction during the month preceding the test. The total score ranges from 0 to 21 points, with a total score greater than 5 indicating poor sleep.
Measured: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Insomnia Severity Index
The Insomnia Severity Index (ISI) is a validated tool for assessing the severity of insomnia symptoms and their impact on daily functioning. The scores for each item are summed to obtain a total score, which ranges from 0 to 28, with higher scores indicating worse sleep. A total score greater than 8 suggests the presence of insomnia.
Measured: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Actigraphy sleep efficiency (%)
Sleep parameters were measured using wrist actigraphy (GT9X; Manufacturing Technology, Pensacola, FL, USA) to collect sleep data. Mean sleep efficiency was derived from actigraphy recordings as the ratio of total sleep time to time in bed, multiplied by 100. Restlessness, indicated by a sleep efficiency below 80%, should be carefully considered in elderly individuals.
Measured: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Actigraphy total sleep time (minutes)
Sleep parameters are measured by the wrist actigraphy (GT9X; Manufacturing Technology, Pensacola, FL, USA) to collect sleep data. Mean total sleep time derived from actigraphy recordings.
Measured: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Actigraphy wake duration (minutes)
Sleep parameters are measured by the wrist actigraphy (GT9X; Manufacturing Technology, Pensacola, FL, USA) to collect sleep data. Mean wake after sleep onset derived from actigraphy recordings.
Measured: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Actigraphy sleep onset latency (minutes)
Sleep parameters are measured by the wrist actigraphy (GT9X; Manufacturing Technology, Pensacola, FL, USA) to collect sleep data. Mean sleep onset latency derived from actigraphy recordings. Restlessness, indicated if more than 30-60 minutes, should be carefully considered in elderly individuals.
Measured: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Actigraphy time in bed (minutes)
Sleep parameters are measured by the wrist actigraphy (GT9X; Manufacturing Technology, Pensacola, FL, USA) to collect sleep data. Mean time in bed derived from actigraphy recordings.
Measured: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Actigraphy sleep fragmentation (%)
Sleep parameters are measured by the wrist actigraphy (GT9X; Manufacturing Technology, Pensacola, FL, USA) to collect sleep data. Sleep fragmentation index (sum of limb movement and fragmentation indexes). The restlessness index during sleep, expressed as a percentage, indicates sleep disruption; higher values mean more disrupted sleep.
Measured: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-You, YE, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572878
- Sponsor's protocol ID
- N202404122
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Cognitive and Physical Training on Mild Cognitive Impairment Elder's Physical and Cognition Domain: A Clinical Trial.
- ClinicalTrials.gov ID
- NCT06572878
- Acronym / sponsor ID
- N202404122
- Conditions
- Cognitive Impairment, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Aug 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.
This study examines the impact of combining cognitive and physical training, recognizing that daily living often requires individuals to perform multiple tasks simultaneously. The inability to execute such dual movements can hinder daily functioning.
The primary goal is to enhance the ability of individuals with mild cognitive impairment (MCI) to perform two tasks concurrently, focusing on both cognitive and physical aspects. This research aims to deepen our understanding of how multitasking affects patients' abilities and to develop effective intervention programs.
Detailed description
The World Health Organization has recognized cognitive impairment as a significant global health issue, encompassing a spectrum of conditions from mild cognitive impairment to various forms of dementia. These conditions are linked to heightened risks of disability and mortality. In the absence of suitable interventions, cognitive functions typically exhibit a gradual decline over time, driven by factors including aging, neurological disorders, traumatic brain injury, and substance abuse.
A thorough literature review indicates that cognitive and physical training can sustain cognitive or physical functions, contingent upon the specific training protocols implemented. Concurrent cognitive and physical training entails the simultaneous execution of multiple cognitive and motor activities, thereby maintaining dual functional control. This innovative training modality integrates motor and cognitive rehabilitation into a cohesive framework.
This clinical trial adopts a randomized controlled design, stratifying participants into four distinct groups: cognitive training, physical training, combined cognitive and physical training, and passive informational activities. The interventions will be administered with a frequency of three times per week over a 12-week period, incorporating task-specific training to enhance both motor and cognitive functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive training | Experimental | Other: Cognitive trainingEach participant will receive cognitive training for 45 minutes per session, three sessions per week, for 12 weeks. |
| Physical training | Experimental | Other: Physical trainingEach participant will receive physical training for 45 minutes per session, three sessions per week, for 12 weeks. |
| Combined cognitive and physical training | Experimental | Other: Combined cognitive and physical trainingEach participant will receive combined cognitive and physical training for 45 minutes per session, three sessions per week, for 12 weeks. |
| Passive information activities | Active comparator | Other: Passive information activitiesEach participant will engage in passive information activities for 45 minutes per session, three sessions per week, for 12 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be aged 60 years or older and able to communicate in Mandarin or Taiwanese.
- Mild cognitive impairment, assessed using the Mini Mental State Examination (MMSE) with a score of 14≦MMSE≦25.
- Self-reported complaints of cognitive decline.
- In addition to the above criteria, participants must voluntarily agree to participate and sign an informed consent form.
Key exclusion criteria (4 listed)
- Individuals with severe psychiatric disorders or behavioral problems, as assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) with (a) severity score ≥ 6 and caregiver distress score ≥ 7.
- Participants who have undergone other cognitive or activity training within the past six months.
- Individuals with sensory impairments, such as visual, auditory, or communication difficulties.
- People with mobility impairments, such as those who use wheelchairs or mobility aids.
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 |
|---|---|---|
| Cognitive trainingCognitive training will follow a group format, with each group consisting of 4-16 participants. Each group will be in a private, independent room for their training sessions and will not interact with participants from other groups. The cognitive training task components will specifically focus on attention, learning and memory, executive function, perceptual-motor skills, and language. | Other | Cognitive training |
| Physical trainingPhysical training will follow a group format, with each group consisting of 4-16 participants. Each group will be in a private, independent room for their training sessions and will not interact with participants from other groups. The physical training task components will specifically focus on strength, balance, agility, gait, low-volume aerobic, and flexibility. | Other | Physical training |
| Combined cognitive and physical trainingCombined cognitive and physical training will follow a group format, with each group consisting of 4-16 participants. Each group will be in a private, independent room for their training sessions and will not interact with participants from other groups. The combined cognitive and physical training components will specifically focus on a single cognitive task and simultaneously handle a single physical task. | Other | Combined cognitive and physical training |
| Passive information activitiesIn passive informational activities, which include a variety of puzzles, audiobooks, and diverse reading materials such as newspapers or listening to news content. | Other | Passive information activities |
Primary outcome
Mini-Mental State Examination
Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
The Mini-Mental State Examination (MMSE) is a standardized instrument for assessing overall cognitive function, where higher scores indicate better global cognition, with a total score ranging from 0 to 30. It is crucial to consider both age and education levels when interpreting the results.
Wisconsin Card Sorting Test - Computer Version
Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
The Wisconsin Card Sorting Test (WCST) is a standardized instrument for assessing executive function. Interpreting WCST results includes analyzing the total correct responses and total errors. The total correct responses indicate the number of correct matches made by the participant; a higher number of correct responses suggests better overall cognitive performance and the ability to learn and apply the rules. Conversely, a high number of errors can indicate difficulties in understanding or applying the sorting rules.
Digit Span Test
Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
A standardized instrument for assessing working memory.
Shor-form Berg balance scale
Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
The Short-Form Berg Balance Scale (SFBBS) is a streamlined assessment tool designed to evaluate an individual's balance and stability. Each item on the SFBBS is scored on a scale from 0 to 4, with 0 indicating the lowest level of function and 4 indicating the highest level of function. The scores for each item are summed to obtain a total score, which provides an overall measure of balance. The maximum possible score varies depending on the number of items included in the short form.
Back scratch test
Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
A flexibility test.
Chair sit-and-reach test
Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
A flexibility test.
Grip and pinch strength
Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
A standardized instrument " PABLO®" for assessing strength.
Gait analysis
Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
A standardized instrument " PABLO®" for assessing gait performance.
8 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Insomnia Severity Index
Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Actigraphy sleep efficiency (%)
Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Actigraphy total sleep time (minutes)
Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Actigraphy wake duration (minutes)
Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Actigraphy sleep onset latency (minutes)
Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Actigraphy time in bed (minutes)
Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Actigraphy sleep fragmentation (%)
Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No. The investigators do not plan to make individual participant data (IPD) available to other researchers.
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training, Physical training and Combined cognitive and physical training in people with Cognitive Impairment and Mild Cognitive Impairment, 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia-You Ye, MSN (+886-9-03254198, tddey1224@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention). 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 27 Aug 2024.