Mild Cognitive ImpairmentNCT01724151
Effects of Exercise Training in Patients With Mild Cognitive Impairment
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The proposes of this study are 1. To understand the physical activities of patients with cognitive impairment in Taiwan and construct the validity and reliability of the physical activity questionnaire and actigram in this population. 2. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2009to Apr 2012
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic,community sample
Who may be able to join
- Above 45 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 ADL/IADL, and not demented
- Diagnosis of Alzheimer's disease based on NINCDS-ADRDA criteria for probable AD (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 proposes of this study are
- To understand the physical activities of patients with cognitive impairment in Taiwan and construct the validity and reliability of the physical activity questionnaire and actigram in this population.
- To understand the relation between brain structure (brain tractography and resting state functional MRI) and cognitive and physical functions of patients with cognitive impairment, the capability of activity and social engagement (including quality of life).
- To understand the efficacy of exercise on the brain structure (brain tractography and resting state functional MRI), cognitive and physical functions, the capability of activity and social engagement (including quality of life) of the patients with cognitive impairment.
The study aims to establish the data base of physical activity of patients with cognitive impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on physical function, physical activity and social engagements to provide an optimized design of exercise program for patients with cognitive impairment in the future.
Read the detailed description
There is already evidence that exercise training can delay the progression of dementia. But if the same effect could be seen in patients with cognitive impairment remains unknown. There is an increasing importance of how to delay or prevent the turn over of cognitive impairment patients into dementia in recent years. Thus we propose to investigate the following issues.
- To understand the physical activities of patients with cognitive impairment in Taiwan and construct the validity and reliability of the physical activity questionnaire and actigram in this population.
- To understand the relation between brain structure (brain tractography and resting state functional MRI) and cognitive and physical functions of patients with cognitive impairment , the capability of activity and social engagement (including quality of life).
- To understand the efficacy of exercise on the brain structure (brain tractography and resting state functional MRI), cognitive and physical functions, the capability of activity and social engagement (including quality of life) of patients with cognitive impairment.
The study is a cross sectional study. We recruited 40 cognitive impairment patients from the memory clinic at National Taiwan University Hospital and another 20 healthy controls matched for age and gender. We collected the actigram and physical activity from questionnaire for 7 days and performed the analysis for reliability and validity. We will do correlation analysis with the data with resting state functional MRI and tractography, brain connectivity, and plasma Aβ1-40 and Aβ1-42 amyloid protein.
The study aims to establish the data base of physical activity of patients with cognitive impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on physical function, physical activity and social engagements to provide an optimized design of exercise program for patients with cognitive impairment in the future.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Healthy adults, over 45 years old | |
| Mild cognitive impairment | subjects with mild cognitive impairment | |
| Alzheimer's disease | subjects with Alzheimer's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed of participants
Subjects walk through 10m walkway with steady comfortable pace. We record complete duration and calculate walking speed (m/sec)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startApr 2009
- Primary completionOct 2009
- Study completionApr 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Jang Chiu, Study chair, Neurology department, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724151
- Sponsor's protocol ID
- 200812152R
- Status last verified
- Apr 2014
- First submitted
- 25 Feb 2010
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 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
- ClinicalTrials.gov ID
- NCT01724151
- Acronym / sponsor ID
- 200812152R
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Nov 2012 (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 proposes of this study are
- To understand the physical activities of patients with cognitive impairment in Taiwan and construct the validity and reliability of the physical activity questionnaire and actigram in this population.
- To understand the relation between brain structure (brain tractography and resting state functional MRI) and cognitive and physical functions of patients with cognitive impairment, the capability of activity and social engagement (including quality of life).
- To understand the efficacy of exercise on the brain structure (brain tractography and resting state functional MRI), cognitive and physical functions, the capability of activity and social engagement (including quality of life) of the patients with cognitive impairment.
The study aims to establish the data base of physical activity of patients with cognitive impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on physical function, physical activity and social engagements to provide an optimized design of exercise program for patients with cognitive impairment in the future.
Detailed description
There is already evidence that exercise training can delay the progression of dementia. But if the same effect could be seen in patients with cognitive impairment remains unknown. There is an increasing importance of how to delay or prevent the turn over of cognitive impairment patients into dementia in recent years. Thus we propose to investigate the following issues.
- To understand the physical activities of patients with cognitive impairment in Taiwan and construct the validity and reliability of the physical activity questionnaire and actigram in this population.
- To understand the relation between brain structure (brain tractography and resting state functional MRI) and cognitive and physical functions of patients with cognitive impairment , the capability of activity and social engagement (including quality of life).
- To understand the efficacy of exercise on the brain structure (brain tractography and resting state functional MRI), cognitive and physical functions, the capability of activity and social engagement (including quality of life) of patients with cognitive impairment.
The study is a cross sectional study. We recruited 40 cognitive impairment patients from the memory clinic at National Taiwan University Hospital and another 20 healthy controls matched for age and gender. We collected the actigram and physical activity from questionnaire for 7 days and performed the analysis for reliability and validity. We will do correlation analysis with the data with resting state functional MRI and tractography, brain connectivity, and plasma Aβ1-40 and Aβ1-42 amyloid protein.
The study aims to establish the data base of physical activity of patients with cognitive impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on physical function, physical activity and social engagements to provide an optimized design of exercise program for patients with cognitive impairment in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | –Healthy adults, over 45 years old |
| Mild cognitive impairment | – | –subjects with mild cognitive impairment |
| Alzheimer's disease | – | –subjects with Alzheimer's disease |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic,community sample
Key inclusion criteria (3 listed)
- Above 45 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 ADL/IADL, and not demented
- Diagnosis of Alzheimer's disease based on NINCDS-ADRDA criteria for probable AD (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.
Primary outcome
Walking speed of participants
Time frame: 1 hour
Subjects walk through 10m walkway with steady comfortable pace. We record complete duration and calculate walking speed (m/sec)
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 22 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 study chair
Neurology department, 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?
An observational study of 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 22 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?
Walking speed of participants (time frame: 1 hour). 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 22 Apr 2014.