UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041039 |
|---|---|
| Receipt number | R000046860 |
| Scientific Title | Elucidation of effective exercise therapy for patients with mild cognitive impairment |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2025/07/14 09:38:10 |
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Basic information
Public title
Elucidation of effective exercise therapy for patients with mild cognitive impairment
Acronym
Elucidation of effective exercise therapy for patients with mild cognitive impairment
Scientific Title
Elucidation of effective exercise therapy for patients with mild cognitive impairment
Scientific Title:Acronym
Elucidation of effective exercise therapy for patients with mild cognitive impairment
Region
| Japan |
Condition
Condition
cognitive impairment
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Motor function and cognitive function are highly interconnected, and it is essential that orthopedics and internal medicine (especially neurology) cooperate to intervene when cognitive impairment is mild. For orthopedics, we believe that the early intervention of locomo in the elderly is important for the treatment of cognitive impairment. Most patients with cognitive impairment have locomotive syndrome, and we propose that a thorough physical intervention by a physical therapist has a positive effect on cognitive function.
However, in the conventional studies on cognitive impairment and locomotive syndrome, there are many epidemiological surveys using cross-sectional studies in Japan and abroad, and it is necessary to make a full-scale study on how rehabilitation intervention improves motor function and cognitive impairment associated with locomotive syndrome. There are not many long-term intervention surveys. Furthermore, it is not known what kind of exercise therapy is most appropriate. The purpose of this study is to clarify the more appropriate method of motor organ rehabilitation using a randomized controlled trial in patients with mild cognitive impairment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changing score in cognitive function (MMSE score/MoCA-J)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Locomotion group: Hand over a pamphlet of locomotion training ((single leg standing, squat, heel raise, front lunge) and check the training once a week by a physiotherapist. Locomotion training taught at home except on the day of hospital visit Do it yourself.
Interventions/Control_2
Exercise intervention group by a therapist: resistance + balance (yoga, etc.) + exercises tailored to aerobics while performing individualized exercises as a multitasking outpatient visit once a week to confirm training by a physical therapist To do. Except for outpatient visits, each individual exercises a personal menu instructed at home.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who visited the outpatient clinic of the Dementia Medical Center, were diagnosed with mild cognitive impairment, and were confirmed to have locomotive levels 1 and 2 and confirmed their willingness to participate in the study and obtained consent
Key exclusion criteria
Spinal disorders with neurological symptoms such as cervical myelopathy and lumbar spinal canal stenosis
Patients with pacemakers
History of implant surgery for artificial joints
Those who have long-term care insurance
Those who cannot answer the questionnaire
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Nakagawa |
Organization
Department of Orthopaedic Surgery Spine Care Center
Division name
Wakayama medical university Kihoku hospital
Zip code
649-7113
Address
Myogi 219, Ito gun
TEL
0736-22-0066
m-tera@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Teraguchi |
Organization
Wakayama medical university Kihoku hospital
Division name
Department of Orthopaedic Surgery Spine Care Center
Zip code
649-7113
Address
Myogi 219, Ito gun
TEL
0736-22-0066
Homepage URL
https://www.wakayama-med.ac.jp/med/bun-in/
m-tera@wakayama-med.ac.jp
Sponsor or person
Institute
Japan Science and Technology Agency
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama medical university
Address
Kimiidera 811-1, Wakayama city
Tel
0734472300
wa-rinri@wakayama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/chubu/66/3/66_445/_pdf
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.11359/chubu.2023.445
Number of participants that the trial has enrolled
10
Results
The subjects consisted of 4 males and 6 females, with a mean age of 73.2 years. Due to the small sample size, no statistically significant differences were observed; however, MMSE scores and the severity and extent of hippocampal atrophy around the hippocampus using VSRAD showed improvement trends. Furthermore, EQ-5D-5L, Locomo-25, 2-step test, and Timed Up & Go test each showed improvement trends. Locomotive syndrome degree improved in 4 cases, with no deterioration observed.
Results date posted
| 2025 | Year | 07 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This is a prospective observational study of patients diagnosed with MCI who visited the outpatient clinic at the Dementia Medical Center, Kihoku Branch of Wakayama Medical University Hospital. MCI patients were defined as those with Mini-Mental State Examination (MMSE) scores between 21 and 27 points, or those diagnosed by dementia specialists. The survey items included changes in cognitive function (MMSE scores), changes in the degree and extent of hippocampal atrophy using the Voxel-based Specific Regional Analysis System for Alzheimer's Disease (VSRAD), and motor assessment items including changes in locomotive syndrome test scores, Locomo-25 scores, 2-step test and Timed Up & Go test results, as well as evaluation of changes in health-related quality of life using EQ-5D-5L. The intervention involved using CogniBike (CB01, manufactured by InterReha) for approximately 20 minutes of dual-task (DT) training combining cognitive tasks (consisting of 6 types: 1.number picking, 2.rock-paper-scissors, 3.number memory, 4.color matching, 5.animal matching, and 6.calculation) with pedaling ergometer exercise, conducted once weekly in the rehabilitation room. Additionally, home-based exercise therapy was prescribed, with implementation managed through diary records.
Participant flow
During health screenings, subjects with MMSE scores of 27 points or below were recruited and encouraged to participate in the study.
Adverse events
None in particular.
Outcome measures
Changes in MMSE scores, changes in the degree and extent of hippocampal atrophy using VSRAD, locomotive syndrome test, changes in Locomo-25 scores, 2-step test, changes in Timed Up & Go test, and changes in EQ-5D-5L.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046860
