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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034671
Receipt No. 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 2019/05/01

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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
Email 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
Email ntnyf092@yahoo.co.jp

Sponsor
Institute Nihon university
Institute
Department

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
Email 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 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
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
2019 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039521

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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