Mild CognitIve ImpairmentNCT02119546
Effects of Exercise Training in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease
A study testing Aerobic exercise and Stretch exercise in people with Mild CognitIve Impairment and Alzheimer's Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purposes of this study are: 1. To investigate whether a 3-month exercise training program would improve cognitive function, motor performance, integrity of brain fiber tracts and cerebral blood flow; 2. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Mild CognitIve Impairment, Alzheimer's Disease
- What is being tested?
- Aerobic exercise and Stretch exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2010to Dec 2012
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45~85 years old and had independent walking ability
- The MCI is diagnosed basically on Petersen's criteria (Petersen, 2001), CDR score of 0.5 but normal activity of daily living /instrumental activities of daily living, and not demented
- Diagnosis of Alzheimer's disease based on NINCDS-ADRDA criteria for probable Alzheimer disease (McKhann, et al., 1984)
Who cannot join
- The subjects who had any neurological, musculoskeletal, cardio-pulmonary disorder which would cause gait disorder or cognitive dysfunction such as stroke, Parkinson disease, or arthritis were excluded
Trial locations and contacts
1 site in 1 country.
About this study
The purposes of this study are:
- To investigate whether a 3-month exercise training program would improve cognitive function, motor performance, integrity of brain fiber tracts and cerebral blood flow;
- To investigate the possible neuro-anatomical and neurophysiological mechanisms of exercise training on cognitive function, motor performance, integrity of brain fiber tract and cerebral blood flow in patients with mild cognitive impairment and in those with early Alzheimer's disease;
- To investigate the influence of different apolipoprotein E (APOE) genotypes on the above-mentioned exercise effects.
The results of this study will provide medical evidence for the effects of exercise training on mild cognitive impairment and on early Alzheimer's disease; and will provide understanding of the mechanisms mediating these effects. More importantly, the results serve as the basis for future larger-scale exercise clinical trials for these two patient populations.
Read the detailed description
Recent studies have shown that exercise training could decrease the risk of dementia in the elderly population. Exercise training could also slow down the speed of deterioration of memory and other cognitive functions in patients who already have mild cognitive impairment or early Alzheimer's disease. However, the mechanisms of such effects are still unknown. Whether exercise training could improve neural fiber integrity, blood flow, or motor performance of these patients also remain unexplored.
Therefore, the purposes of this study are:
- To investigate whether a 3-month exercise training program would improve cognitive function, motor performance, integrity of brain fiber tracts and cerebral blood flow;
- To investigate the possible neuro-anatomical and neurophysiological mechanisms of exercise training on cognitive function, motor performance, integrity of brain fiber tract and cerebral blood flow in patients with mild cognitive impairment and in those with early Alzheimer's disease;
- To investigate the influence of different APOE genotypes on the above-mentioned exercise effects.
We will conduct a single-blinded, randomized controlled clinical trial. We will recruit 60 patients with mild cognitive impairment or early Alzheimer's disease. The participants will be randomly classified into the exercise training group or control group. The exercise training group will receive health education and exercise training of moderate intensity, 3 times a week, for 12 weeks. The control group will receive health education only. Both groups will receive pre- (week 0), post- (week 12), and follow-up (week 24 after the end of the program) examinations for cognitive function, motor performance, diffusion tensor or diffusion spectrum magnetic resonance imaging, and transcranial duplex. We will compare the group differences on the aforementioned outcome measures brought by 12-week exercise training. We will also perform analysis of the correlations between the changes in these outcome measures to explore the possible neural or physiological mechanisms mediating the training effects. The effects of different APOE genotypes on these outcome measures will also be compared.
The results of this study will provide medical evidence for the effects of exercise training on mild cognitive impairment and on early Alzheimer's disease; and will provide understanding of the mechanisms mediating these effects. More importantly, the results serve as the basis for future larger-scale exercise clinical trials for these two patient populations.
- Conditions
- Mild CognitIve Impairment, Alzheimer's Disease
- Being tested
- Aerobic exercise, Stretch exercise
- Keywords
- Mild CognitIve impairment, Alzheimer's disease, Cognitive function, Exercise training
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Aerobic exercise and dual-task training
Stretch exerciseOther
Stretch exercise \& sitting balance
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | Aerobic exercise and dual-task training Receives: Other: Aerobic exercise |
| Stretch exercise | Active comparator | Stretch exercise \& sitting balance Receives: Other: Stretch exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Color Trails Test at week12 and Week24
To investigate the cognitive executive function
Measured: Baseline, Week12, Week24
Secondary outcomes (1)
Change from baseline in walking speed at week12 and Week24
To investigate walking ability
Measured: baseline, week12 and Week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMay 2010
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild CognitIve ImpairmentStudies 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
- 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, Neurology department, National Taiwan University HospitalYu-Hsiu Chu, PhD, Principal investigator, Department of Physical Therapy, China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119546
- Sponsor's protocol ID
- 200912126R
- Status last verified
- Apr 2014
- First submitted
- 19 Nov 2012
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02119546
- Acronym / sponsor ID
- 200912126R
- Conditions
- Mild CognitIve Impairment, Alzheimer's Disease
- Keywords
- Mild CognitIve impairment, Alzheimer's disease, Cognitive function, Exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Apr 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.
The purposes of this study are:
- To investigate whether a 3-month exercise training program would improve cognitive function, motor performance, integrity of brain fiber tracts and cerebral blood flow;
- To investigate the possible neuro-anatomical and neurophysiological mechanisms of exercise training on cognitive function, motor performance, integrity of brain fiber tract and cerebral blood flow in patients with mild cognitive impairment and in those with early Alzheimer's disease;
- To investigate the influence of different apolipoprotein E (APOE) genotypes on the above-mentioned exercise effects.
The results of this study will provide medical evidence for the effects of exercise training on mild cognitive impairment and on early Alzheimer's disease; and will provide understanding of the mechanisms mediating these effects. More importantly, the results serve as the basis for future larger-scale exercise clinical trials for these two patient populations.
Detailed description
Recent studies have shown that exercise training could decrease the risk of dementia in the elderly population. Exercise training could also slow down the speed of deterioration of memory and other cognitive functions in patients who already have mild cognitive impairment or early Alzheimer's disease. However, the mechanisms of such effects are still unknown. Whether exercise training could improve neural fiber integrity, blood flow, or motor performance of these patients also remain unexplored.
Therefore, the purposes of this study are:
- To investigate whether a 3-month exercise training program would improve cognitive function, motor performance, integrity of brain fiber tracts and cerebral blood flow;
- To investigate the possible neuro-anatomical and neurophysiological mechanisms of exercise training on cognitive function, motor performance, integrity of brain fiber tract and cerebral blood flow in patients with mild cognitive impairment and in those with early Alzheimer's disease;
- To investigate the influence of different APOE genotypes on the above-mentioned exercise effects.
We will conduct a single-blinded, randomized controlled clinical trial. We will recruit 60 patients with mild cognitive impairment or early Alzheimer's disease. The participants will be randomly classified into the exercise training group or control group. The exercise training group will receive health education and exercise training of moderate intensity, 3 times a week, for 12 weeks. The control group will receive health education only. Both groups will receive pre- (week 0), post- (week 12), and follow-up (week 24 after the end of the program) examinations for cognitive function, motor performance, diffusion tensor or diffusion spectrum magnetic resonance imaging, and transcranial duplex. We will compare the group differences on the aforementioned outcome measures brought by 12-week exercise training. We will also perform analysis of the correlations between the changes in these outcome measures to explore the possible neural or physiological mechanisms mediating the training effects. The effects of different APOE genotypes on these outcome measures will also be compared.
The results of this study will provide medical evidence for the effects of exercise training on mild cognitive impairment and on early Alzheimer's disease; and will provide understanding of the mechanisms mediating these effects. More importantly, the results serve as the basis for future larger-scale exercise clinical trials for these two patient populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Other: Aerobic exerciseAerobic exercise and dual-task training |
| Stretch exercise | Active comparator | Other: Stretch exerciseStretch exercise \& sitting balance |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 45~85 years old and had independent walking ability
- The MCI is diagnosed basically on Petersen's criteria (Petersen, 2001), CDR score of 0.5 but normal activity of daily living /instrumental activities of daily living, and not demented
- Diagnosis of Alzheimer's disease based on NINCDS-ADRDA criteria for probable Alzheimer disease (McKhann, et al., 1984)
Key exclusion criteria (1 listed)
- The subjects who had any neurological, musculoskeletal, cardio-pulmonary disorder which would cause gait disorder or cognitive dysfunction such as stroke, Parkinson disease, or arthritis were excluded
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 exerciseAerobic exercise and dual-task training | Other | Exercise intervention |
| Stretch exerciseStretch exercise \& sitting balance | Other | Stretch exercise |
Primary outcome
Change from baseline in Color Trails Test at week12 and Week24
Time frame: Baseline, Week12, Week24
To investigate the cognitive executive function
1 secondary outcome
Change from baseline in walking speed at week12 and Week24
Time frame: baseline, week12 and Week24
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 21 Apr 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
Neurology department, National Taiwan University Hospital
Yu-Hsiu Chu, PhD principal investigator
Department of Physical Therapy, China Medical 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 Aerobic exercise and Stretch exercise in people with Mild CognitIve Impairment and 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 3 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 21 Apr 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?
Change from baseline in Color Trails Test at week12 and Week24 (time frame: Baseline, Week12, Week24). 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 21 Apr 2014.