DementiaNCT03811314
The Therapeutic Effect of Exercise Training on Patients With Dementia and Mild Cognitive Impairment
A study testing Strength training, Aerobic training and Isokinetic trinaing in people with Dementia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Dementia
- What is being tested?
- Strength training, Aerobic training and Isokinetic trinaing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Apr 2018to 26 Dec 2023
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Dementia
- Being tested
- Strength training, Aerobic training, Isokinetic trinaing, Isotonic training
- Keywords
- Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingDevice
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
Aerobic trainingDevice
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
Isokinetic trinaingDevice
Using Biodex isokinetic dynanometer and set it in isokinetic mode in 60 degree per second
Isotonic trainingDevice
Using Biodex isokinetic dynanometer and set it in isotonic mode at 60% of the maximal peak torque
| Study group | Role | What they receive |
|---|---|---|
| Strength training | Experimental | Muscle strength training programs Receives: Device: Strength training |
| Aerobic training | Experimental | Aerobic training programs Receives: Device: Aerobic training |
| Isokinetic training | Experimental | Isokinetic training Receives: Device: Isokinetic trinaing |
| Isotonic training | Experimental | Isotonic training Receives: Device: Isotonic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel index
To evaluate function of activities of daily living, range from 0-100, higher values represent a better outcome
Measured: 4 weeks
Mini-mental state examination
To evaluate cognitive function, range from 0-30, higher values represent a better outcome
Measured: 4 weeks
Montreal Cognitive Assessment
To evaluate cognitive function, range from 0-30, higher values represent a better outcome
Measured: 4 weeks
Geriatric Depression Scale
To evaluate patient's depression status, range from 0-15, higher values represent a worse outcome
Measured: 4 weeks
Timed up and go test
Measure the time taken by a patient to stand up from a chair, walk three meters, return, and sit back on the chair
Measured: 4 weeks
SF-36
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.
Measured: 4 weeks
Secondary outcomes (3)
Concentration of serum brain derived neurotrophic factor (BDNF)
Increasing BDNF level is related to preventing neurodegeneration.
Measured: 4 weeks
Concentration of plasma insulin-like growth factor-1 (IGF-1)
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.
Measured: 4 weeks
Concentration of plasmamonocyte chemotactic protein-1 (MCP-1)
The elevation of MCP-1 concentration usually means the progression of systemic inflammation.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start9 Apr 2018
- Primary completion26 Dec 2023
- Study completion26 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General 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
- Parallel groups
- Model description
- comparison of therapeutic effect between aerobic and strength training on dementia patient, and comparison of therapeutic effect between isokinetic and isotonic training on patients with mild cognitive impairment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan-Yang Cheng, MDPHD, Principal investigator, Department of rehabilitation of Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811314
- Sponsor's protocol ID
- CF18010B
- Status last verified
- Feb 2024
- First submitted
- 13 Jan 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu IT, Lee WJ, Lin SY, Chang ST, Kao CL, Cheng YY. Therapeutic Effects of Exercise Training on Elderly Patients With Dementia: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 May;101(5):762-769. doi: 10.1016/j.apmr.2020.01.012. Epub 2020 Feb 19.
PubMed 32084347
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Exercise Training on Old Patients With Dementia and Mild Cognitive Impairment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03811314
- Acronym / sponsor ID
- CF18010B
- Conditions
- Dementia
- Keywords
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- 26 Dec 2023 (actual)
- First posted
- 22 Jan 2019 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- comparison of therapeutic effect between aerobic and strength training on dementia patient, and comparison of therapeutic effect between isokinetic and isotonic training on patients with mild cognitive impairment
| Arm | Type | Receives |
|---|---|---|
| Strength training | Experimental | Device: Strength trainingMuscle strength training programs |
| Aerobic training | Experimental | Device: Aerobic trainingAerobic training programs |
| Isokinetic training | Experimental | Device: Isokinetic trinaingIsokinetic training |
| Isotonic training | Experimental | Device: Isotonic trainingIsotonic training |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Strength trainingUsing 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 | Device | Strength training |
| Aerobic trainingUsing 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 | Device | Aerobic training |
| Isokinetic trinaingUsing Biodex isokinetic dynanometer and set it in isokinetic mode in 60 degree per second | Device | Isokinetic training |
| Isotonic trainingUsing Biodex isokinetic dynanometer and set it in isotonic mode at 60% of the maximal peak torque | Device | Isotonic training |
Primary outcome
Barthel index
Time frame: 4 weeks
To evaluate function of activities of daily living, range from 0-100, higher values represent a better outcome
Mini-mental state examination
Time frame: 4 weeks
To evaluate cognitive function, range from 0-30, higher values represent a better outcome
Montreal Cognitive Assessment
Time frame: 4 weeks
To evaluate cognitive function, range from 0-30, higher values represent a better outcome
Geriatric Depression Scale
Time frame: 4 weeks
To evaluate patient's depression status, range from 0-15, higher values represent a worse outcome
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
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.
3 secondary outcomes
Concentration of serum brain derived neurotrophic factor (BDNF)
Time frame: 4 weeks
Concentration of plasma insulin-like growth factor-1 (IGF-1)
Time frame: 4 weeks
Concentration of plasmamonocyte chemotactic protein-1 (MCP-1)
Time frame: 4 weeks
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 2024.
- Derived from this study: PubMed 32084347Liu IT, Lee WJ, Lin SY, Chang ST, Kao CL, Cheng YY. Therapeutic Effects of Exercise Training on Elderly Patients With Dementia: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 May;101(5):762-769. doi: 10.1016/j.apmr.2020.01.012. Epub 2020 Feb 19.
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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.
Yuan-Yang Cheng, MDPHD principal investigator
Department of rehabilitation of Taichung Veterans General 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 Strength training, Aerobic training and Isokinetic trinaing in people with Dementia, run by Taichung Veterans General 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 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?
Barthel index (time frame: 4 weeks). The study lists 6 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 NCT03811314, which also lists 1 linked publication.
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 2024.