UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032292 |
|---|---|
| Receipt number | R000036771 |
| Scientific Title | Examination of the factor in conjunction with a change and the improvement of the lower limbs muscular strength by the different group repititive standing exercise intervention of the stance width in long-term care health facilites for the elderly woman |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2019/01/18 20:36:18 |
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Basic information
Public title
Examination of the factor in conjunction with a change and the improvement of the lower limbs muscular strength by the different group repititive standing exercise intervention of the stance width in long-term care health facilites for the elderly woman
Acronym
Examination of the factor in conjunction with a change and the improvement of the lower limbs muscular strength by the different group repititive standing exercise intervention of the stance width in long-term care health facilites for the elderly woman
Scientific Title
Examination of the factor in conjunction with a change and the improvement of the lower limbs muscular strength by the different group repititive standing exercise intervention of the stance width in long-term care health facilites for the elderly woman
Scientific Title:Acronym
Examination of the factor in conjunction with a change and the improvement of the lower limbs muscular strength by the different group repititive standing exercise intervention of the stance width in long-term care health facilites for the elderly woman
Region
| Japan |
Condition
Condition
orthopedic diseases, neurosurgical diseases, internal disorders, geriatric syndrome
Classification by specialty
| Medicine in general | Surgery in general | Orthopedics |
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study conducted a randomized crossover comparative trial on a user of a female elderly who has been in long-term care for geriatrics and underwent massive closed leg repetitive standing exercise and group open leg repeated erecting movements with different stance widths over 16 weeks each of these isometric lower limb muscular strengths, this time knee extension muscle strength: quadriceps muscle (KE), knee flexion muscle strength: hamstrings (KF), hip external rotation muscle strength : external rotation muscle group (ER), hip internal rotation muscle strength: internal rotation muscle group (IR) will be compared and examined. We aim to examine the physical factors, fundamental movement ability factors, ADL factors of the group with the most improved muscular strength among the two types of intervention methods, and confirm the adaptation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Isometric knee extension muscle force, isometric knee flexion muscle force, isometric hip external rotation muscle force, isometric hip internal rotation muscle force
Key secondary outcomes
age, disease,onset,presence or absence of motor paralysis (BRS), height, weight, BMI, grip strength, standing frequency, Mini-mental state examination (MMSE), basic movement ability (BMS), daily of living activity ability (FIM)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
METHODS: A group open leg repetitive standing exercise
Duration: 16 weeks
Frequency: twice a week
Number of times: 32 times
Interventions/Control_2
METHODS: A group closed leg repetitive standing exercise
Duration: 16 weeks
Frequency: twice a week
Number of times: 32 times
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
| 75 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
1 Possible to hold the end sitting position by handrail
2 Standing motion from the chair is possible
3 Open legs and closed legs can be used during the standing motion
Key exclusion criteria
1 I can not understand verbal instruction2 exercise therapy withdrawal standard falls under
3 There is pain when exercising with arthritis
4 There is severe motor paralysis
5 There is progressive disease
6 There are severe knee extravasation / varus
7 short term intensive rehabilitation is applicable
8 Exercise therapy for this study is easy
9 We can not obtain research cooperation
10 Judge that the research manager is inappropriate as the subject
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Fujii |
Organization
Incorporated Administrative Agency Regional Medical Function Promotion Organization Tokuyama Central Hospital affiliated long-term care geriatric health facility
Division name
Long-Term Care Health Facility Departmen
Zip code
Address
1-1 Kodacyou, Shunan-shi, Yamaguchi Prefecture
TEL
0834-28-8686
tokuvr22@flute.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Fujii |
Organization
Incorporated Administrative Agency Regional Medical Function Promotion Organization Tokuyama Central
Division name
Long-Term Care Health Facility Departmen
Zip code
Address
1-1 Kodacyou, Shunan-shi, Yamaguchi Prefecture
TEL
0834-28-8686
Homepage URL
tokuvr22@flute.ocn.ne.jp
Sponsor or person
Institute
Incorporated Administrative Agency Regional Medical Function Promotion Organization Tokuyama Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Incorporated Administrative Agency Regional Medical Function Promotion Organization Tokuyama Central 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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
K307-20180412
Org. issuing International ID_1
Incorporated Administrative Agency Regional Medical Function Promotion Organization Tokuyama Central Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
独立行政法人地域医療機能推進機構徳山中央病院附属介護老人保健施設
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 17 | Day |
Last modified on
| 2019 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036771
