DementiaNCT04951258
Multicomponent Exercise in People With Dementia
A study testing Multicomponent exercise and Video home exercise group in people with Dementia, run by National Yang Ming Chiao Tung University.
Trial summary
People with dementia shows a decline in cognition, such as memory, executive function (EF), language, attention, and spatial orientation that is significant enough to interfere with the independence and daily functioning. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Dementia
- What is being tested?
- Multicomponent exercise and Video home exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 60-80 y/o
- Mini-Mental State Examination: 10-26
- Clinical Dementia Rating: 1-2
- Walk at least 6 meters independently (with or without walking aids)
Who cannot join
- Any other diagnosis of neurological diseases or musculoskeletal problems (Except dementia)
- Physical or psychological comorbidities that affect performance during assessment or intervention
- Already participating in other physical training in the last 1 month
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Multicomponent Exercise on Cognitive Function and Activities of Daily Living in People With Dementia
People with dementia shows a decline in cognition, such as memory, executive function (EF), language, attention, and spatial orientation that is significant enough to interfere with the independence and daily functioning. Previous studies reported that multicomponent exercise improved EF in people with mild cognitive impairment and independence of ADL in those with Alzheimer's disease. However, few studies investigated whether multicomponent exercise improved EF, memory, and ADL in people with dementia. Therefore, the purposes of this study are to examine 1) the effect of multicomponent exercise on EF, memory, and ADL in people with mild to moderate dementia; 2) the correlation between change in EF and ADL; 3) the correlation between change in memory and ADL.
- Conditions
- Dementia
- Being tested
- Multicomponent exercise, Video home exercise group
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exerciseOther
The intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Multicomponent exercise included strengthening, balance training, aerobic dance, and stretching
Video home exercise groupOther
The intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Video home exercise included four limbs mobility exercise, stretching, strengthening, and aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent exercise group | Experimental | Not described Receives: Other: Multicomponent exercise |
| Video home exercise group | Active comparator | Not described Receives: Other: Video home exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination
It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Higher scores mean a better outcome.
Measured: Change from baseline at 9 week
Chinese version of Verbal learning test
It is a 9-point measurement to evaluate memory. Higher scores mean a better outcome.
Measured: Change from baseline at 9 week
Chinese version of Stroop color and word test
It is a measurement to evaluate inhibition control.
Measured: Change from baseline at 9 week
Digit span test
It is a measurement to evaluate working memory.
Measured: Change from baseline at 9 week
Trail making test - Chinese version
It is a measurement to evaluate cognitive flexibility.
Measured: Change from baseline at 9 week
Secondary outcomes (7)
Barthel index
It is a 100-point ordinal scale used to measure performance in activities of daily living. Higher scores mean a better outcome.
Measured: Change from baseline at 9 week
Instrumental activities of daily living (IADL) scale
It is a 24-point ordinal scale used to measure performance in instrumental activities of daily living. Higher scores mean a better outcome.
Measured: Change from baseline at 9 week
Chinese version of Quality of Life in Alzheimer Disease Scale
It is a measurement to evaluate quality of life. The scale scores range from 13 to 52, with higher scores indicating greater quality of life.
Measured: Change from baseline at 9 week
Time up and go test
It is a test to evaluate functional mobility.
Measured: Change from baseline at 9 week
30-second chair stand test
It is a test to evaluate muscle strength.
Measured: Change from baseline at 9 week
6-minute walk test
It is a test to evaluate endurance.
Measured: Change from baseline at 9 week
Berg Balance Scale
It is a tool to evaluate balance. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Measured: Change from baseline at 9 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951258
- Sponsor's protocol ID
- YM110062F
- Status last verified
- Aug 2021
- First submitted
- 18 Jun 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multicomponent Exercise on Cognitive Function and Activities of Daily Living in People With Dementia
- ClinicalTrials.gov ID
- NCT04951258
- Acronym / sponsor ID
- YM110062F
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Jul 2021 (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.
People with dementia shows a decline in cognition, such as memory, executive function (EF), language, attention, and spatial orientation that is significant enough to interfere with the independence and daily functioning. Previous studies reported that multicomponent exercise improved EF in people with mild cognitive impairment and independence of ADL in those with Alzheimer's disease. However, few studies investigated whether multicomponent exercise improved EF, memory, and ADL in people with dementia. Therefore, the purposes of this study are to examine 1) the effect of multicomponent exercise on EF, memory, and ADL in people with mild to moderate dementia; 2) the correlation between change in EF and ADL; 3) the correlation between change in memory and ADL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent exercise group | Experimental | Other: Multicomponent exercise |
| Video home exercise group | Active comparator | Other: Video home exercise group |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 60-80 y/o
- Mini-Mental State Examination: 10-26
- Clinical Dementia Rating: 1-2
- Walk at least 6 meters independently (with or without walking aids)
Key exclusion criteria (3 listed)
- Any other diagnosis of neurological diseases or musculoskeletal problems (Except dementia)
- Physical or psychological comorbidities that affect performance during assessment or intervention
- Already participating in other physical training in the last 1 month
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 |
|---|---|---|
| Multicomponent exerciseThe intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Multicomponent exercise included strengthening, balance training, aerobic dance, and stretching | Other | Multicomponent exercise group |
| Video home exercise groupThe intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Video home exercise included four limbs mobility exercise, stretching, strengthening, and aerobic exercise | Other | Video home exercise group |
Primary outcome
Mini-Mental State Examination
Time frame: Change from baseline at 9 week
It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Higher scores mean a better outcome.
Chinese version of Verbal learning test
Time frame: Change from baseline at 9 week
It is a 9-point measurement to evaluate memory. Higher scores mean a better outcome.
Chinese version of Stroop color and word test
Time frame: Change from baseline at 9 week
It is a measurement to evaluate inhibition control.
Digit span test
Time frame: Change from baseline at 9 week
It is a measurement to evaluate working memory.
Trail making test - Chinese version
Time frame: Change from baseline at 9 week
It is a measurement to evaluate cognitive flexibility.
7 secondary outcomes
Barthel index
Time frame: Change from baseline at 9 week
Instrumental activities of daily living (IADL) scale
Time frame: Change from baseline at 9 week
Chinese version of Quality of Life in Alzheimer Disease Scale
Time frame: Change from baseline at 9 week
Time up and go test
Time frame: Change from baseline at 9 week
30-second chair stand test
Time frame: Change from baseline at 9 week
6-minute walk test
Time frame: Change from baseline at 9 week
Berg Balance Scale
Time frame: Change from baseline at 9 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent exercise and Video home exercise group in people with Dementia, run by National Yang Ming Chiao Tung University.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yea-Ru Yang, Professor (+886-2-28267279, yryang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (time frame: Change from baseline at 9 week). The study lists 5 primary outcomes in all. 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 24 Aug 2021.