Mild Cognitive ImpairmentNCT03619577
The Effectiveness of Combining Physical Exercise and Cognitive Training for Individuals With Mild Cognitive Impairment
A study testing Sequential training in people with Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Mild cognitive impairment (MCI) is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The progression rate from MCI to dementia ranges from 10 to 15% each year, resulting in increased family care and medical expenses. Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Sequential training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jan 2018to Jun 2022
- 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 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to follow instruction (MMSE>= 17)
- self- or informant-reported memory or cognitive complaint.
Who cannot join
- recent myocardial infarction,heart failure,recent heart surgery,
- severe asthma, concomitant with other neurological disorders, or joint deformity that might prevents them performing exercise or cognitive training.
Trial locations and contacts
1 site in 1 country.
About this study
Mild cognitive impairment (MCI) is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The progression rate from MCI to dementia ranges from 10 to 15% each year, resulting in increased family care and medical expenses. Therefore, providing effective interventions are necessary. Combining cognitive training and physical exercise training appears to have effects to prevent the progression of MCI to Alzheimer's disease or other severe cognitive impairment. It was proposed that cognitively challenging stimulations can increase the neural network and promote neural plasticity, which are essential for preventing cognitive decline in patients with MCI. The studies also showed that physical exercise induces positive effects on cerebral blood flow and induces brain activation changes of the frontal, parietal, and temporal areas; these cortical areas are especially important for memory and other cognitive functions. However, it is yet not clear the appropriate frequency of the effective intervention for patients with MCI. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency sequential training for patients with MCI.
Read the detailed description
Mild cognitive impairment (MCI) is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The progression rate from MCI to dementia ranges from 10 to 15% each year, resulting in increased family care and medical expenses. Therefore, providing effective interventions are necessary. Combining cognitive training and physical exercise training appears to have effects to prevent the progression of MCI to Alzheimer's disease or other severe cognitive impairment. It was proposed that cognitively challenging stimulations can increase the neural network and promote neural plasticity, which are essential for preventing cognitive decline in patients with MCI. The studies also showed that physical exercise induces positive effects on cerebral blood flow and induces brain activation changes of the frontal, parietal, and temporal areas; these cortical areas are especially important for memory and other cognitive functions. However, it is yet not clear the appropriate frequency of the effective intervention for patients with MCI. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency sequential training for patients with MCI.
Investigators anticipate recruiting a total of 80 participants with MCI. The participants will be assigned into 2 groups: high frequency sequential training (HF) and low frequency sequential training (LF) groups. The participants of HF will receive a total of 36 training sessions, and each session will contain 90-105 minutes of training. The participants of LF will receive a total of 12 training sessions, and each session will contain 90-105 minutes of training. The BrainHQ program, self-made teaching aids and board games will be used to train different cognitive functions of the participants. For physical exercise, Investigators design the programs that involve balance or strength training components in the aerobic exercises. All participants will first perform 45-55 minutes of physical exercise followed by 45-50 minutes of cognitive training. Investigators plan to assess the participants before and after the intervention programs. The primary outcome measures are cognitive functions, including visuospatial processing, attention, memory, and/or executive functions. The secondary outcome measures include physical functions and activities of daily living (ADLs). Investigators expect to use the paired-t test and analysis of covariance (ANCOVA) to analyze differences in baseline characteristics and baseline outcome measures between the groups and determine the intervention effect for the 2 groups.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Sequential training
- Keywords
- Mild Cognitive Impairment, cognitive training, exercise
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential trainingBehavioural
For cognitive training, the BrainHQ program, self-made teaching aids and board games will be used to train different cognitive functions of the participants. For physical exercise, we design the programs that involve balance or strength training components in the aerobic exercises. All participants will first perform 60 minutes of physical exercise followed by 60 minutes of cognitive training.
| Study group | Role | What they receive |
|---|---|---|
| Sequential training-high frequency | Experimental | The participants of HF will receive a total of 36 training sessions, and each session will contain 90-105 minutes of training. The participants in this group will first perform 45-55 minutes of physical exercise followed by 45-50 minutes of cognitive training. The participants in this group participate in multimodel exercise programs including aerobic exercise, balance, and strength training. The entire program will contain 5-10 minutes of warm-up, 35-40 minutes of physical exercise, and 5 minutes of cool-down. Then, the participants will practice tasks that involve the abilities of visuospatial processing, attention, memory, language, and/or executive functions for 45-50 minutes. Receives: Behavioral: Sequential training |
| Sequential training-low frequency | Experimental | The participants of LF will receive a total of 12 training sessions, and each session will contain 90-105 minutes of training. The participants in this group will first perform 45-55 minutes of physical exercise followed by 45-50 minutes of cognitive training. The participants in this group participate in multimodel exercise programs including aerobic exercise, balance, and strength training. The entire program will contain 5-10 minutes of warm-up, 35-40 minutes of physical exercise, and 5 minutes of cool-down. Then, the participants will practice tasks that involve the abilities of visuospatial processing, attention, memory, language, and/or executive functions for 45-50 minutes. Receives: Behavioral: Sequential training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
Measured: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Change scores of the Stroop test
The Stroop test will be used to assess the processing speed, inhibition, set-shifting, and selective attention abilities. The participants will be tested under 2 conditions: congruent and incongruent conditions. In the congruent condition, the color ink of a word is consistent with the written color name; while the color ink differs from the written color name under the incongruent condition.
Measured: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Change scores of the Dual-task test
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically
Measured: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Change scores of the Timed up and go (TUG) test
The TUG test will be used to assess the mobility and dynamic balance ability. The participants will be required to stand up from a chair, walk 3 meters, turn around, then walk back to the chair, and sit down. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers and frail elderly (Podsiadlo \& Richardson, 1991). The test-retest reliability of TUG on individuals with cognitive impairment was excellent.
Measured: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Change scores of the Wechsler Memory Scale (WMS)
Tests of the Wechsler Memory Scale (WMS) will be used to measure the memory functions of an individual. The WMS have high reliability and validity, and is often used to differentiate individuals with memory deficits and those with intact cognitive functions. In addition, WMS could be used to assess cognitive improvements after an intervention or treatment. There are eight Primary Indexes (Auditory Immediate (was Verbal), Visual Immediate (was Visual), Immediate Memory (new), Auditory Delayed (new), Visual Delayed (new), Auditory Reception Delayed (new), General Memory (only delayed subtest scores), and Working Memory), which constitute Immediate Memory, General (Delayed) Memory, and Working Memory (was Attention/Concentration). Approximately 60 to 90 minutes is required for completion.
Measured: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL)
Assess activities of daily living. There are 8 domains of function measured with the Lawton IADL scale, including ability to use phone,shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications,and ability to handle finances. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent). For each category, circle the item description that most closely resembles the client's highest functional level (either 0 or 1).
Measured: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Change scores of the Wechsler Adult Intelligence Scale (WAIS)
Subtests of the Wechsler Adult Intelligence Scale (WAIS) will be used to measure the cognitive functions of an individual. The WAIS have high reliability and validity, and is often used to differentiate individuals with cognitive deficits and those with intact cognitive functions. In addition, WAIS could be used to assess cognitive improvements after an intervention or treatment.
Measured: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Change scores of Memory complaint questionnaire
The MAC-Q consists of six items. The first five items relate to specific situations that are frequently reported as troublesome for those with declining memory, and the last item broadly measures overall self-perceived memory decline. Respondents must choose one of the 5 options ranging from much better now to much worse now. The total possible score is 30 points.
Measured: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Change scores of Spatial Span Test
The Spatial Span Task is a behavioral measure of working memory capacity, the cognitive ability to store and manage information on a transient basis.
On each trial the squares change from white to a different color in a sequence with variable orders and colors. The task exists with two variants: forward-span and backward-span. In the forward-span variant, at the end of each list participants attempt to recall the squares in the order they changed color by typing keys corresponding to each square via keypress. In the backward-span variant, at the end of each list participants attempt to recall the squares in the reverse order that they changed color. The difficulty level is systematically increased by varying the number of boxes on each trial from two boxes (easiest) to nine boxes (most difficult).
Measured: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Secondary outcomes (3)
Change scores of the short form of the Geriatric Depression Scale (GDS-SF)
The Chinese version of short form GDS will be used. The short-form version comprising 15 items. Answers indicating depression are in bold and italicized; score one point for each one selected. A score of 0 to 5 is normal. A score greater than 5 suggests depression.
Measured: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Change scores of the Community Integration Questionnaire (CIQ)
The CIQ measures items relevant to home integration, social integration, and productive activities.
Measured: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Change scores of the Everyday Cognition scales (ECog)-12 items
To detect cognitive and functional decline. The ECog shows promise as a useful tool for the measurement of general and domain-specific everyday functions in the elderly. There are six domains (Everyday Memory, Language, Visuospatial Abilities, Planning, Organization, and Divided Attention) in ECog. Lower scores represent a higher level of function in daily life.
Measured: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start30 Jan 2018
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-yi Wu, ScD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619577
- Sponsor's protocol ID
- 201711EM006
- Status last verified
- May 2021
- First submitted
- 23 Jul 2018
- Last updated
- 17 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chuang IC, Chen IC, Wu YR, Li KY. Prediction and mediation analysis for treatment responses to combined cognitive and physical training for older adults. Sci Rep. 2024 May 8;14(1):10571. doi: 10.1038/s41598-024-61407-6.
PubMed 38720025Chuang IC, Chen IC, Su KH, Wu YR, Wu CY. The effects of high versus low frequency of combined physical and cognitive training on cognitive function in older adults with cognitive decline: a quasi-experimental study. BMC Geriatr. 2023 Feb 14;23(1):94. doi: 10.1186/s12877-023-03802-8.
PubMed 36788482
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Combining Physical Exercise and Cognitive Training for Individuals With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03619577
- Acronym / sponsor ID
- 201711EM006
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, cognitive training, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 8 Aug 2018 (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.
Mild cognitive impairment (MCI) is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The progression rate from MCI to dementia ranges from 10 to 15% each year, resulting in increased family care and medical expenses. Therefore, providing effective interventions are necessary. Combining cognitive training and physical exercise training appears to have effects to prevent the progression of MCI to Alzheimer's disease or other severe cognitive impairment. It was proposed that cognitively challenging stimulations can increase the neural network and promote neural plasticity, which are essential for preventing cognitive decline in patients with MCI. The studies also showed that physical exercise induces positive effects on cerebral blood flow and induces brain activation changes of the frontal, parietal, and temporal areas; these cortical areas are especially important for memory and other cognitive functions. However, it is yet not clear the appropriate frequency of the effective intervention for patients with MCI. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency sequential training for patients with MCI.
Detailed description
Mild cognitive impairment (MCI) is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The progression rate from MCI to dementia ranges from 10 to 15% each year, resulting in increased family care and medical expenses. Therefore, providing effective interventions are necessary. Combining cognitive training and physical exercise training appears to have effects to prevent the progression of MCI to Alzheimer's disease or other severe cognitive impairment. It was proposed that cognitively challenging stimulations can increase the neural network and promote neural plasticity, which are essential for preventing cognitive decline in patients with MCI. The studies also showed that physical exercise induces positive effects on cerebral blood flow and induces brain activation changes of the frontal, parietal, and temporal areas; these cortical areas are especially important for memory and other cognitive functions. However, it is yet not clear the appropriate frequency of the effective intervention for patients with MCI. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency sequential training for patients with MCI.
Investigators anticipate recruiting a total of 80 participants with MCI. The participants will be assigned into 2 groups: high frequency sequential training (HF) and low frequency sequential training (LF) groups. The participants of HF will receive a total of 36 training sessions, and each session will contain 90-105 minutes of training. The participants of LF will receive a total of 12 training sessions, and each session will contain 90-105 minutes of training. The BrainHQ program, self-made teaching aids and board games will be used to train different cognitive functions of the participants. For physical exercise, Investigators design the programs that involve balance or strength training components in the aerobic exercises. All participants will first perform 45-55 minutes of physical exercise followed by 45-50 minutes of cognitive training. Investigators plan to assess the participants before and after the intervention programs. The primary outcome measures are cognitive functions, including visuospatial processing, attention, memory, and/or executive functions. The secondary outcome measures include physical functions and activities of daily living (ADLs). Investigators expect to use the paired-t test and analysis of covariance (ANCOVA) to analyze differences in baseline characteristics and baseline outcome measures between the groups and determine the intervention effect for the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential training-high frequency | Experimental | Behavioral: Sequential trainingThe participants of HF will receive a total of 36 training sessions, and each session will contain 90-105 minutes of training. The participants in this group will first perform 45-55 minutes of physical exercise followed by 45-50 minutes of cognitive training. The participants in this group participate in multimodel exercise programs including aerobic exercise, balance, and strength training. The entire program will contain 5-10 minutes of warm-up, 35-40 minutes of physical exercise, and 5 minutes of cool-down. Then, the participants will practice tasks that involve the abilities of visuospatial processing, attention, memory, language, and/or executive functions for 45-50 minutes. |
| Sequential training-low frequency | Experimental | Behavioral: Sequential trainingThe participants of LF will receive a total of 12 training sessions, and each session will contain 90-105 minutes of training. The participants in this group will first perform 45-55 minutes of physical exercise followed by 45-50 minutes of cognitive training. The participants in this group participate in multimodel exercise programs including aerobic exercise, balance, and strength training. The entire program will contain 5-10 minutes of warm-up, 35-40 minutes of physical exercise, and 5 minutes of cool-down. Then, the participants will practice tasks that involve the abilities of visuospatial processing, attention, memory, language, and/or executive functions for 45-50 minutes. |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- able to follow instruction (MMSE>= 17)
- self- or informant-reported memory or cognitive complaint.
Key exclusion criteria (2 listed)
- recent myocardial infarction,heart failure,recent heart surgery,
- severe asthma, concomitant with other neurological disorders, or joint deformity that might prevents them performing exercise or cognitive training.
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 |
|---|---|---|
| Sequential trainingFor cognitive training, the BrainHQ program, self-made teaching aids and board games will be used to train different cognitive functions of the participants. For physical exercise, we design the programs that involve balance or strength training components in the aerobic exercises. All participants will first perform 60 minutes of physical exercise followed by 60 minutes of cognitive training. | Behavioural | Sequential training-high frequency, Sequential training-low frequency |
Primary outcome
Change scores of the Montreal Cognitive Assessment (MoCA)
Time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
Change scores of the Stroop test
Time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
The Stroop test will be used to assess the processing speed, inhibition, set-shifting, and selective attention abilities. The participants will be tested under 2 conditions: congruent and incongruent conditions. In the congruent condition, the color ink of a word is consistent with the written color name; while the color ink differs from the written color name under the incongruent condition.
Change scores of the Dual-task test
Time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically
Change scores of the Timed up and go (TUG) test
Time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
The TUG test will be used to assess the mobility and dynamic balance ability. The participants will be required to stand up from a chair, walk 3 meters, turn around, then walk back to the chair, and sit down. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers and frail elderly (Podsiadlo \& Richardson, 1991). The test-retest reliability of TUG on individuals with cognitive impairment was excellent.
Change scores of the Wechsler Memory Scale (WMS)
Time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Tests of the Wechsler Memory Scale (WMS) will be used to measure the memory functions of an individual. The WMS have high reliability and validity, and is often used to differentiate individuals with memory deficits and those with intact cognitive functions. In addition, WMS could be used to assess cognitive improvements after an intervention or treatment. There are eight Primary Indexes (Auditory Immediate (was Verbal), Visual Immediate (was Visual), Immediate Memory (new), Auditory Delayed (new), Visual Delayed (new), Auditory Reception Delayed (new), General Memory (only delayed subtest scores), and Working Memory), which constitute Immediate Memory, General (Delayed) Memory, and Working Memory (was Attention/Concentration). Approximately 60 to 90 minutes is required for completion.
Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL)
Time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Assess activities of daily living. There are 8 domains of function measured with the Lawton IADL scale, including ability to use phone,shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications,and ability to handle finances. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent). For each category, circle the item description that most closely resembles the client's highest functional level (either 0 or 1).
Change scores of the Wechsler Adult Intelligence Scale (WAIS)
Time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Subtests of the Wechsler Adult Intelligence Scale (WAIS) will be used to measure the cognitive functions of an individual. The WAIS have high reliability and validity, and is often used to differentiate individuals with cognitive deficits and those with intact cognitive functions. In addition, WAIS could be used to assess cognitive improvements after an intervention or treatment.
Change scores of Memory complaint questionnaire
Time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
The MAC-Q consists of six items. The first five items relate to specific situations that are frequently reported as troublesome for those with declining memory, and the last item broadly measures overall self-perceived memory decline. Respondents must choose one of the 5 options ranging from much better now to much worse now. The total possible score is 30 points.
Change scores of Spatial Span Test
Time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
The Spatial Span Task is a behavioral measure of working memory capacity, the cognitive ability to store and manage information on a transient basis. On each trial the squares change from white to a different color in a sequence with variable orders and colors. The task exists with two variants: forward-span and backward-span. In the forward-span variant, at the end of each list participants attempt to recall the squares in the order they changed color by typing keys corresponding to each square via keypress. In the backward-span variant, at the end of each list participants attempt to recall the squares in the reverse order that they changed color. The difficulty level is systematically increased by varying the number of boxes on each trial from two boxes (easiest) to nine boxes (most difficult).
3 secondary outcomes
Change scores of the short form of the Geriatric Depression Scale (GDS-SF)
Time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Change scores of the Community Integration Questionnaire (CIQ)
Time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Change scores of the Everyday Cognition scales (ECog)-12 items
Time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Derived from this study: PubMed 38720025Chuang IC, Chen IC, Wu YR, Li KY. Prediction and mediation analysis for treatment responses to combined cognitive and physical training for older adults. Sci Rep. 2024 May 8;14(1):10571. doi: 10.1038/s41598-024-61407-6.
- Derived from this study: PubMed 36788482Chuang IC, Chen IC, Su KH, Wu YR, Wu CY. The effects of high versus low frequency of combined physical and cognitive training on cognitive function in older adults with cognitive decline: a quasi-experimental study. BMC Geriatr. 2023 Feb 14;23(1):94. doi: 10.1186/s12877-023-03802-8.
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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.
Ching-yi Wu, ScD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential training in people with Mild Cognitive Impairment, run by Chang Gung Memorial 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 2 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 17 May 2021. 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?
Results are not available in the source record.
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?
Change scores of the Montreal Cognitive Assessment (MoCA) (time frame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03619577, which also lists 2 linked publications.
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 17 May 2021; AzTrials last refreshed its copy on 5 Nov 2026.