UMIN-CTR Clinical Trial

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