Amnestic Mild Cognitive ImpairmentNCT04103463
Interactive Stepping Exercise on Memory
A study testing Interactive stepping exercise and Home exercise in people with Amnestic Mild Cognitive Impairment and Interactive Stepping Exercise, run by National Yang Ming Chiao Tung University.
Trial summary
This is a randomized controlled trail. A total of 28 individuals with aMCI will be randomly assigned to either the ISE group or control group. The ISE intervention conducts three times a week for 16 weeks. Outcomes are measured at baseline and after intervention. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Amnestic Mild Cognitive Impairment, Interactive Stepping Exercise, Memory
- What is being tested?
- Interactive stepping exercise and Home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 31 Jul 2021
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥50 years
- Complained of memory impairment
- Chinese Version Verbal Learning Test 10-minute delays ≤ 6 words
- MMSE score≥24 and CDR score=0.5
- Activities of daily living are intact
- DSM-IV criteria for the diagnosis of dementia is not met
Who cannot join
- Any significant neurologic disease other than suspected incipient Alzheimer's disease
- Psychotic features, contraindication of exercise... which could lead to difficulty complying with the protocol
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Interactive Stepping Exercise on Memory in Adults With Amnestic Mild Cognitive Impairment
This is a randomized controlled trail. A total of 28 individuals with aMCI will be randomly assigned to either the ISE group or control group. The ISE intervention conducts three times a week for 16 weeks. Outcomes are measured at baseline and after intervention. The primary outcomes are the Chinese version verbal learning test (CVVLT), selective reminding test (SRT), and logic memory test (Wechsler Memory Scale). The secondary outcomes are Montreal Cognitive Assessment (MoCA) for cognitive function, and trail making test Part A \& B (TMT-A \& B), Stroop test, and 25-item Executive Interview (C-EXIT 25) for executive function.
- Conditions
- Amnestic Mild Cognitive Impairment, Interactive Stepping Exercise, Memory, Cognitive Function, Executive Function
- Being tested
- Interactive stepping exercise, Home exercise
- Keywords
- square stepping exercise, Amnestic mild cognitive impairment, Interactive stepping exercise, memory, cognitive function, executive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive stepping exerciseOther
An exercise intervention based on the principle of square stepping exercise
Home exerciseOther
Home exercise
| Study group | Role | What they receive |
|---|---|---|
| Interactive stepping exercise group | Experimental | Not described Receives: Other: Interactive stepping exercise |
| Home exercise group | Active comparator | Not described Receives: Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese version verbal learning test
Measured: Change from baseline at 12 week
Selective reminding test
Measured: Change from baseline at 12 week
Wechsler Memory Scale-III
Measured: Change from baseline at 12 week
Logic memory test
Measured: Change from baseline at 12 week
Secondary outcomes (4)
Montreal Cognitive Assessment
Measured: Change from baseline at 12 week
Trail making test
Measured: Change from baseline at 12 week
Stroop test
Measured: Change from baseline at 12 week
Executive Interview
Measured: Change from baseline at 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amnestic Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- 30 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
- NCT04103463
- Sponsor's protocol ID
- YM108072F
- Status last verified
- Sep 2019
- First submitted
- 20 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interactive Stepping Exercise on Memory in Adults With Amnestic Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04103463
- Acronym / sponsor ID
- YM108072F
- Conditions
- Amnestic Mild Cognitive Impairment, Interactive Stepping Exercise, Memory, Cognitive Function, Executive Function
- Keywords
- square stepping exercise, Amnestic mild cognitive impairment, Interactive stepping exercise, memory, cognitive function, executive function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 25 Sep 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 is a randomized controlled trail. A total of 28 individuals with aMCI will be randomly assigned to either the ISE group or control group. The ISE intervention conducts three times a week for 16 weeks. Outcomes are measured at baseline and after intervention. The primary outcomes are the Chinese version verbal learning test (CVVLT), selective reminding test (SRT), and logic memory test (Wechsler Memory Scale). The secondary outcomes are Montreal Cognitive Assessment (MoCA) for cognitive function, and trail making test Part A \& B (TMT-A \& B), Stroop test, and 25-item Executive Interview (C-EXIT 25) for executive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive stepping exercise group | Experimental | Other: Interactive stepping exercise |
| Home exercise group | Active comparator | Other: Home exercise |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age≥50 years
- Complained of memory impairment
- Chinese Version Verbal Learning Test 10-minute delays ≤ 6 words
- MMSE score≥24 and CDR score=0.5
- Activities of daily living are intact
Key exclusion criteria (2 listed)
- Any significant neurologic disease other than suspected incipient Alzheimer's disease
- Psychotic features, contraindication of exercise... which could lead to difficulty complying with the protocol
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 |
|---|---|---|
| Interactive stepping exerciseAn exercise intervention based on the principle of square stepping exercise | Other | Interactive stepping exercise group |
| Home exerciseHome exercise | Other | Home exercise group |
Primary outcome
Chinese version verbal learning test
Time frame: Change from baseline at 12 week
Selective reminding test
Time frame: Change from baseline at 12 week
Wechsler Memory Scale-III
Time frame: Change from baseline at 12 week
Logic memory test
Time frame: Change from baseline at 12 week
4 secondary outcomes
Montreal Cognitive Assessment
Time frame: Change from baseline at 12 week
Trail making test
Time frame: Change from baseline at 12 week
Stroop test
Time frame: Change from baseline at 12 week
Executive Interview
Time frame: Change from baseline at 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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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 Interactive stepping exercise and Home exercise in people with Amnestic Mild Cognitive Impairment and Interactive Stepping Exercise, 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 6 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: status not confirmed, as of the sponsor's last update on 25 Sep 2019. 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 (+886228267279, yryang@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese version verbal learning test (time frame: Change from baseline at 12 week). The study lists 4 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 25 Sep 2019.