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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041039
Receipt No. 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 2020/07/09

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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
Email 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/
Email m-tera@wakayama-med.ac.jp

Sponsor
Institute Japan Science and Technology Agency
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
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
2020 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046860

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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