UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034671 |
|---|---|
| Receipt number | R000039521 |
| Scientific Title | Prospective evaluation of Health-Related Quality of Life(HRQOL)and determinants after rehabilitation in musculoskeletal disease in elderly. |
| Date of disclosure of the study information | 2018/10/28 |
| Last modified on | 2020/05/23 04:54:40 |
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Basic information
Public title
Prospective evaluation of Health-Related Quality of Life(HRQOL)and determinants after rehabilitation in musculoskeletal disease in elderly.
Acronym
Prospective evaluation of Health-Related Quality of Life(HRQOL)and determinants in musculoskeletal disease in elderly.
Scientific Title
Prospective evaluation of Health-Related Quality of Life(HRQOL)and determinants after rehabilitation in musculoskeletal disease in elderly.
Scientific Title:Acronym
Prospective evaluation of Health-Related Quality of Life(HRQOL)and determinants in musculoskeletal disease in elderly.
Region
| Japan |
Condition
Condition
Musculoskeletal disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In rehabilitation treatment in elderly patients with musculoskeletal disease by increase of patients background and the chronic disease than healing and life lengthening maintenance, the increase of the function and improvement of the quality of life of the treatment came to be aimed.
Therefore the medical audit is insufficient, and the rehabilitation intervention that is appropriate by patients standpoint outcome index such as HRQOL(health-related quality of life) is necessary for only traditional outcome index such as the improvement of the vital prognosis.
We conduct an investigation, analysis based on patients standpoint outcome evaluation about basic information (sex, age, history, involved site, working, the social resource use, living condition) of patients with musculoskeletal disease in elderly,HRQOL, IADL(instrumental activities of daily living), a fall sense of fear, an atrabiliary degree, and a purpose of this study is to establish identification and the rehabilitation optimum intervention method of the HRQOL determinants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement rate of HRQOL
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects agree to cooperation to this study among patients with advanced age locomotorium disease that started rehabilitation in this hospital from October 1, 2018 to March 31, 2019 65 years or older and do informed consent with an obtained case.
Key exclusion criteria
1.There is a proposal of the study entry rejection from study patients
2.we judge that a study person in charge should exclude subjects
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University Hospital
Division name
Orthopedic surgery
Zip code
101-8309
Address
1-6, Kandasurugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
ntnyf092@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University Hospital
Division name
Orthopedic surgery
Zip code
101-8309
Address
1-6, Kandasurugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
Homepage URL
ntnyf092@yahoo.co.jp
Sponsor or person
Institute
Nihon university
Institute
Department
Personal name
Funding Source
Organization
Orthopedic surgery, Nihon university school of medicine.
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
Nihon University Hospital
Address
1-6, Kandasurugadai, Chiyoda-ku, Tokyo
Tel
03-3293-1711
suzuki.ikumi@nihon-u.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
日本大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
170
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
Main results already published
Date of protocol fixation
| 2018 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
The subject is the person who agreed to cooperation to this study among patients with advanced age locomotorium disease that underwent rehabilitation in this hospital.
We distribute it directly one month later after one or two, three months and rehabilitation were completed after rehabilitation initiation time and initiation by self-entry-style inventory survey, and the investigation method collects it after a medical examination.The subjects agree to cooperation to this study among patients with advanced age locomotorium disease that started rehabilitation in this hospital from October 1, 2018 to March 31, 2019 65 years or older and do informed consent with an obtained case.
Management information
Registered date
| 2018 | Year | 10 | Month | 28 | Day |
Last modified on
| 2020 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039521
