Alzheimer's DiseaseNCT02074215
Effect of Exercises Training in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease
A study testing Aerobic exercises and Stretch exercise in people with Alzheimer's Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Recent studies have shown that aerobic exercises and dual-task training are effective in improving overall cognitive function in patients with cognitive impairment or dementia. However, the biological mechanisms are unknown in humans. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Aerobic exercises and Stretch exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to Dec 2013
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild cognitive impairment or mild AD.
Who cannot join
- neurological disorders or psychiatric disorders, or any other systematic diseases that would affect their walking ability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects and Mechanisms of Aerobic Exercises Combined With Dual-task Training in Cognitive Function in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease
Recent studies have shown that aerobic exercises and dual-task training are effective in improving overall cognitive function in patients with cognitive impairment or dementia. However, the biological mechanisms are unknown in humans. It also remains unclear regarding whether carrying APOEε4 genotype or not would influence the effects. Therefore, the three main purposes of this study are: (1) to investigate the effects of a 3-month aerobic exercises combined with dual-task training on memory and executive cognitive functions in patients with mild cognitive impairment (MCI) and in those with early Alzheimer's disease (AD); (2) to compare the differences in training effects between patients who carry APOEε4 genotype and those who do not carry this genotype; and (3) to investigate the biological mechanisms of the exercise training effects on memory and executive cognitive function in these patients. The biological mechanisms of interest will include the blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine, integrity of brain fiber tracts, and cerebral blood flow.
We will conduct a randomized controlled clinical trial. A total of 70 patients with MCI or AD will be recruited. The participants will be randomly assigned to the experimental group or the control group. Both groups will receive three 90-minute exercise sessions per week for 12 weeks. For the experimental group, the exercise program will include moderate intensity aerobic exercises and dual-task training; whereas for the control group, the training program will include gentle stretching exercises. Both groups will receive examinations on outcome variables, including blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine,integrity of brain fiber tracts, cerebral blood flow, cognitive function, and dual task performance at baseline, post-training, and after a 3-month follow-up period. Differences on the aforementioned outcomes brought by the 12-week training programs will be compared between the experimental and control groups. Exercise effects between patients who carry APOEε4 genotype and those who do not will also be examined.
Results of this study will provide relevant clinical evidence for the effects of aerobic exercises combined with dual-task training on patients with MCI and mild AD; and will provide further understanding of the mechanisms mediating these effects.
Read the detailed description
Recent studies have shown that moderate-to-high intensity aerobic exercises are effective in improving overall cognitive function in patients with cognitive impairment or dementia. Dual-task training programs also show positive effects on enhancing executive function in patients with cognitive impairment. However, the biological mechanisms through which these training effects are mediated remain largely unknown in humans. It also remains unclear regarding whether carrying APOEε4 genotype or not would influence the effects of aerobic exercises and dual-task training on cognitive function of these patients. Therefore, the three main purposes of this study are:
- to investigate the effects of a 3-month aerobic exercises combined with dual-task training on memory and executive cognitive functions in patients with mild cognitive impairment (MCI) and in those with early Alzheimer's disease (AD);
- to compare the differences in training effects between patients who carry APOEε4 genotype and those who do not carry this genotype; and
- to investigate the biological mechanisms of the exercise training effects on memory and executive cognitive function in these patients. The biological mechanisms of interest will include the blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine (TNF-α, Interleukin(IL) -Iβ, IL-6, CRP),integrity of brain fiber tracts, and cerebral blood flow.
We will conduct a single-blind (assessor blinded) randomized controlled clinical trial. A total of 70 patients with MCI or AD will be recruited. The participants will be randomly assigned to the experimental group or the control group using stratified randomization by matching patient's diagnosis. Both groups will receive one health education session and three 90-minute exercise sessions per week for 12 weeks. For the experimental group, the exercise program will include moderate intensity aerobic exercises and dual-task training; whereas for the control group, the training program will include gentle stretching exercises and activities in sitting of mild intensity. Both groups will receive examinations on outcome variables, including blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine (TNF-α, IL-Iβ, IL-6, CRP),integrity of brain fiber tracts, cerebral blood flow, cognitive function, and dual task performance at baseline, post-training, and after a 3-month follow-up period. Differences on the aforementioned outcomes brought by the 12-week training programs will be compared between the experimental and control groups using two-way (group x time) repeated measures of ANOVA. Intercorrelations among the changes in these outcomes will be analyzed to explore the possible biological mechanisms mediating the training effects. Exercise effects between patients who carry APOEε4 genotype and those who do not will also be examined.
Results of this study will provide relevant clinical evidence for the effects of aerobic exercises combined with dual-task training on patients with MCI and mild AD; and will provide further understanding of the mechanisms mediating these effects.
- Conditions
- Alzheimer's Disease
- Being tested
- Aerobic exercises, Stretch exercise
- Keywords
- Mild Cognitive Impairment, Alzheimer's disease, Aerobic exercise
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercisesOther
Aerobic exercises + dual task
Stretch exerciseOther
Stretch exercise
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercises | Experimental | 90-minute exercise sessions per week for 12 weeks Receives: Other: Aerobic exercises |
| Stretch exercise | Active comparator | 90-minute exercise sessions per week for 12 weeks Receives: Other: Stretch exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Memory and executive function related neuropsychological test
Measured: Changes from baseline in neuropsychological test at 3 months and 6 months
Secondary outcomes (1)
Changes of muscle strength of upper and lower extremity and walking speed
Measured: Changes from baseline in muscle strength of upper and lower extremity and walking speed at 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Jang Chiu, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074215
- Sponsor's protocol ID
- 201012136RB
- Status last verified
- Feb 2014
- First submitted
- 19 Nov 2012
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Aerobic Exercises Combined With Dual-task Training in Cognitive Function in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02074215
- Acronym / sponsor ID
- 201012136RB
- Conditions
- Alzheimer's Disease
- Keywords
- Mild Cognitive Impairment, Alzheimer's disease, Aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Feb 2014 (estimated)
- 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.
Recent studies have shown that aerobic exercises and dual-task training are effective in improving overall cognitive function in patients with cognitive impairment or dementia. However, the biological mechanisms are unknown in humans. It also remains unclear regarding whether carrying APOEε4 genotype or not would influence the effects. Therefore, the three main purposes of this study are: (1) to investigate the effects of a 3-month aerobic exercises combined with dual-task training on memory and executive cognitive functions in patients with mild cognitive impairment (MCI) and in those with early Alzheimer's disease (AD); (2) to compare the differences in training effects between patients who carry APOEε4 genotype and those who do not carry this genotype; and (3) to investigate the biological mechanisms of the exercise training effects on memory and executive cognitive function in these patients. The biological mechanisms of interest will include the blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine, integrity of brain fiber tracts, and cerebral blood flow.
We will conduct a randomized controlled clinical trial. A total of 70 patients with MCI or AD will be recruited. The participants will be randomly assigned to the experimental group or the control group. Both groups will receive three 90-minute exercise sessions per week for 12 weeks. For the experimental group, the exercise program will include moderate intensity aerobic exercises and dual-task training; whereas for the control group, the training program will include gentle stretching exercises. Both groups will receive examinations on outcome variables, including blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine,integrity of brain fiber tracts, cerebral blood flow, cognitive function, and dual task performance at baseline, post-training, and after a 3-month follow-up period. Differences on the aforementioned outcomes brought by the 12-week training programs will be compared between the experimental and control groups. Exercise effects between patients who carry APOEε4 genotype and those who do not will also be examined.
Results of this study will provide relevant clinical evidence for the effects of aerobic exercises combined with dual-task training on patients with MCI and mild AD; and will provide further understanding of the mechanisms mediating these effects.
Detailed description
Recent studies have shown that moderate-to-high intensity aerobic exercises are effective in improving overall cognitive function in patients with cognitive impairment or dementia. Dual-task training programs also show positive effects on enhancing executive function in patients with cognitive impairment. However, the biological mechanisms through which these training effects are mediated remain largely unknown in humans. It also remains unclear regarding whether carrying APOEε4 genotype or not would influence the effects of aerobic exercises and dual-task training on cognitive function of these patients. Therefore, the three main purposes of this study are:
- to investigate the effects of a 3-month aerobic exercises combined with dual-task training on memory and executive cognitive functions in patients with mild cognitive impairment (MCI) and in those with early Alzheimer's disease (AD);
- to compare the differences in training effects between patients who carry APOEε4 genotype and those who do not carry this genotype; and
- to investigate the biological mechanisms of the exercise training effects on memory and executive cognitive function in these patients. The biological mechanisms of interest will include the blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine (TNF-α, Interleukin(IL) -Iβ, IL-6, CRP),integrity of brain fiber tracts, and cerebral blood flow.
We will conduct a single-blind (assessor blinded) randomized controlled clinical trial. A total of 70 patients with MCI or AD will be recruited. The participants will be randomly assigned to the experimental group or the control group using stratified randomization by matching patient's diagnosis. Both groups will receive one health education session and three 90-minute exercise sessions per week for 12 weeks. For the experimental group, the exercise program will include moderate intensity aerobic exercises and dual-task training; whereas for the control group, the training program will include gentle stretching exercises and activities in sitting of mild intensity. Both groups will receive examinations on outcome variables, including blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine (TNF-α, IL-Iβ, IL-6, CRP),integrity of brain fiber tracts, cerebral blood flow, cognitive function, and dual task performance at baseline, post-training, and after a 3-month follow-up period. Differences on the aforementioned outcomes brought by the 12-week training programs will be compared between the experimental and control groups using two-way (group x time) repeated measures of ANOVA. Intercorrelations among the changes in these outcomes will be analyzed to explore the possible biological mechanisms mediating the training effects. Exercise effects between patients who carry APOEε4 genotype and those who do not will also be examined.
Results of this study will provide relevant clinical evidence for the effects of aerobic exercises combined with dual-task training on patients with MCI and mild AD; and will provide further understanding of the mechanisms mediating these effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercises | Experimental | Other: Aerobic exercises90-minute exercise sessions per week for 12 weeks |
| Stretch exercise | Active comparator | Other: Stretch exercise90-minute exercise sessions per week for 12 weeks |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mild cognitive impairment or mild AD.
Key exclusion criteria (1 listed)
- neurological disorders or psychiatric disorders, or any other systematic diseases that would affect their walking ability
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 |
|---|---|---|
| Aerobic exercisesAerobic exercises + dual task | Other | Aerobic exercises |
| Stretch exerciseStretch exercise | Other | Stretch exercise |
Primary outcome
Changes of Memory and executive function related neuropsychological test
Time frame: Changes from baseline in neuropsychological test at 3 months and 6 months
1 secondary outcome
Changes of muscle strength of upper and lower extremity and walking speed
Time frame: Changes from baseline in muscle strength of upper and lower extremity and walking speed at 3 months and 6 months
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 28 Feb 2014.
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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.
Ming-Jang Chiu, PhD study chair
National Taiwan University 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 Aerobic exercises and Stretch exercise in people with Alzheimer's Disease, 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 1 inclusion and 1 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 28 Feb 2014. 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?
Changes of Memory and executive function related neuropsychological test (time frame: Changes from baseline in neuropsychological test at 3 months and 6 months). 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 28 Feb 2014.