- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811314
The Therapeutic Effect of Exercise Training on Patients With Dementia and Mild Cognitive Impairment
February 26, 2024 updated by: Taichung Veterans General Hospital
The Therapeutic Effect of Exercise Training on Old Patients With Dementia and Mild Cognitive Impairment: A Randomized Controlled Trial
This study aimed to clarify whether strength training or aerobic training could bring more benefits for patients with dementia, another study is to clarify whether isokinetic or isotonic training could bring more benefits for patients with mild cognitive impairment
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Exercise training has been evidenced to bring various of benefits for patients with dementia in past studies.
However, whether strength training or aerobic training could bring better benefits has not been confirmed in the past.
This study designed to recruit 30 patients with mild dementia in the first year.
Every patient will receive strength training using dumbbells, butterfly machine and vertical leg press machine for four weeks.
Outcome measures including self care ability, cognitive function, MCP-1, BDNF and IGF-1 levels, and the degree of depression will be recorded before and after the training.
In the second year, the investigators also designed to recruit 31 patients with mild dementia.
These participants will instead receive aerobic training using stationary bicycle for four weeks.
The same outcome measures will be tested as in the first year.
The other part of the study recruited 46 patients with mild cognitive impairment, who were randomized into either a four-week isokinetic or isotonic training program.
All cases were evaluated by isokinetic peak torque, 36-item Short Form Survey (SF-36), Mini-Mental State Examination (MMSE), Barthel Index, geriatric depression scale (GDS-15), and Timed Up and Go test (TUG test) before and after each kind of training.
Study Type
Interventional
Enrollment (Actual)
107
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria:
- Patients aged above 65 years old
- Patients with mild dementia with Mini-mental state examination scoring 15 to 26
- Another arm is patients with mild cognitive impairment and Mini-mental state examination scoring 23 to 27
Exclusion criteria:
- Cardiopulmonary diseases or orthopedical conditions that prohibit the patient from receiving exercise training of our programs
- Cognitive problems that impede the patient to understand and answer the content of our questionnaires.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Strength training
Muscle strength training programs
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Using dumbbells, butterfly machine and vertical leg press machine for strength training, 12 repetition maximum weight for 12 repetition, three times a day, five days a week, for a total of four weeks
|
Experimental: Aerobic training
Aerobic training programs
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Using stationary bicycle to perform cardiopulmonary endurance training in 50-70 heart rate reserve for 20 minutes, five days per week, for a total of four weeks
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Experimental: Isokinetic training
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Using Biodex isokinetic dynanometer and set it in isokinetic mode in 60 degree per second
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Experimental: Isotonic training
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Using Biodex isokinetic dynanometer and set it in isotonic mode at 60% of the maximal peak torque
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Barthel index
Time Frame: 4 weeks
|
To evaluate function of activities of daily living, range from 0-100, higher values represent a better outcome
|
4 weeks
|
Mini-mental state examination
Time Frame: 4 weeks
|
To evaluate cognitive function, range from 0-30, higher values represent a better outcome
|
4 weeks
|
Montreal Cognitive Assessment
Time Frame: 4 weeks
|
To evaluate cognitive function, range from 0-30, higher values represent a better outcome
|
4 weeks
|
Geriatric Depression Scale
Time Frame: 4 weeks
|
To evaluate patient's depression status, range from 0-15, higher values represent a worse outcome
|
4 weeks
|
Timed up and go test
Time Frame: 4 weeks
|
Measure the time taken by a patient to stand up from a chair, walk three meters, return, and sit back on the chair
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4 weeks
|
SF-36
Time Frame: 4 weeks
|
consists of 36 questions categorized into 8 subdomains, including physical functioning, role limitations due to physical health, pain, general health condition, vitality, social functioning, role limitations due to emotional problems, and emotional well-being.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of serum brain derived neurotrophic factor (BDNF)
Time Frame: 4 weeks
|
Increasing BDNF level is related to preventing neurodegeneration.
|
4 weeks
|
Concentration of plasma insulin-like growth factor-1 (IGF-1)
Time Frame: 4 weeks
|
Lower plasma level of IGF-1 is associated with an increased risk of developing Alzheimer's dementia, and higher levels of it may protect against neurodegeneration.
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4 weeks
|
Concentration of plasmamonocyte chemotactic protein-1 (MCP-1)
Time Frame: 4 weeks
|
The elevation of MCP-1 concentration usually means the progression of systemic inflammation.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yuan-Yang Cheng, MDPHD, Department of rehabilitation of Taichung Veterans General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2018
Primary Completion (Actual)
December 26, 2023
Study Completion (Actual)
December 26, 2023
Study Registration Dates
First Submitted
January 13, 2019
First Submitted That Met QC Criteria
January 17, 2019
First Posted (Actual)
January 22, 2019
Study Record Updates
Last Update Posted (Estimated)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF18010B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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