UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042531 |
|---|---|
| Receipt number | R000048527 |
| Scientific Title | Management of physical therapist exercise interventions on assisted living condominium |
| Date of disclosure of the study information | 2020/11/24 |
| Last modified on | 2020/11/24 13:19:43 |
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Basic information
Public title
Management of physical therapist exercise interventions on assisted living condominium
Acronym
Management of PT exercise interventions on assisted living condominium
Scientific Title
Management of physical therapist exercise interventions on assisted living condominium
Scientific Title:Acronym
Management of PT exercise interventions on assisted living condominium
Region
| Japan |
Condition
Condition
locomotive syndrome, sarcopenia, frailty, dementia
Classification by specialty
| Psychiatry | Orthopedics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In super-aging society of Japan, the maintenance of physical and cognitive functions of the elderly is an urgent issue. The provision and content of effective preventive programs are important for elderly people in serviced housing for the elderly because some of them leave due to physical and cognitive decline. In recent years, knowledge on the effectiveness of exercise therapy in maintaining physical and cognitive function in the elderly has been accumulating, but the effectiveness of exercise therapy in the senior citizen population is still unclear. In addition, although we provide individual exercise programs to those who wish to participate in our "Ayatori" senior citizen residence, the actual effects of the exercise program on individual physical and cognitive function are unknown. The purpose of this study is to clarify the effects of the individualized exercise program on physical and cognitive function in "Ayatori". The significance of this study is threefold: 1) to clarify the effects of the Individualized Exercise Program on physical and cognitive function in the Ayatori, 2) to accumulate basic data to improve the Individualized Exercise Program in Ayatori, and 3) to demonstrate the usefulness of the Individualized Exercise Program in Ayatori, which will be used to improve the physical and cognitive function of the residents s motivation to exercise and differentiate themselves from other senior citizen facilities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Gait assessment
Walk a distance of 5 meters at a speed usually walked at a speed of 5 m and at one's maximum effort
Gait imaging (gait assessment)
Foot-mounted inertial sensors (spatio-temporal evaluation of walking)
Key secondary outcomes
(2) Motor system instability assessment
Time Up & Go Test (TUG): Use foot-mounted sensors as well as gait assessment
(3) Muscle strength assessment
Chair Standing-Sitting Test
Grip strength measurement
4) Cognitive function assessment
Mini-Mental State Examination (MMSE)
Instruction manual of the Japanese version of the Montreal Cognitive Assessment (Moca-J)
(5) Psychological State Assessment
The Center for Epidemiologic Studies Depression Scale (CES-D)
(6) Daily life assessment
Barthel Index (BI)
(7) Obtain basic information on research subjects.
Age, gender, height, weight, foot size, etc.
Use of exercise classes and club activities in Ayatori: participation in exercise classes and various clubs
Use of long-term care insurance services: home rehabilitation, day care, home-visit care, and home-nursing services
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the Individualized Exercise Program, PTs and health exercise instructors propose and instruct individual exercise programs for each resident, and each resident gets about 30 minutes of exercise once or twice a week.
Interventions/Control_2
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who are residents of Ayatori and have agreed to participate in the periodic evaluation
Key exclusion criteria
Those who need assistance (watchful waiting is not included in assistance) to walk
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Homan |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
001-0021
Address
Kita-21 Nishi-11 Kita-Ku Frontier Research Center for Advanced Material and Life Science 3F iwasaki Lab.
TEL
0117069057
k.houman@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuito |
| Middle name | |
| Last name | Odashiro |
Organization
Tokachi Rehabilitation Center
Division name
Department: Rehabilitation Medicine
Zip code
080-0833
Address
7-5 Kisen, Inada-cho, Obihiro-shi, Hokkaido
TEL
0155488000
Homepage URL
one.for.all283283@gmail.com
Sponsor or person
Institute
7-5 Kisen, Inada-cho, Obihiro-shi, Hokkaido
Tokachi Rehabilitation Center
Department: Rehabilitation Medicine
Institute
Department
Personal name
Funding Source
Organization
Hokuto Social Medical Corporation, Hokuto Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokachi Rehabilitation Center
Address
7-5 Kisen, Inada-cho, Obihiro-shi, Hokkaido Tokachi Rehabilitation Center Department: Rehabilitation Medicine
Tel
0155-48-8000
one.for.all283283@gmail.com
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
サービス付き高齢者向け住宅あやとり（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | 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 | 11 | Month | 24 | Day |
Last modified on
| 2020 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048527
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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