UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041808
Receipt No. R000047726
Scientific Title The short-term outcomes of early exercise therapy for patients with oseteoporotic vertebral fractures
Date of disclosure of the study information 2020/09/16
Last modified on 2020/09/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The short-term outcomes of early exercise therapy for patients with oseteoporotic vertebral fractures
Acronym The short-term outcomes of early exercise therapy for patients with oseteoporotic vertebral fractures
Scientific Title The short-term outcomes of early exercise therapy for patients with oseteoporotic vertebral fractures
Scientific Title:Acronym The short-term outcomes of early exercise therapy for patients with oseteoporotic vertebral fractures
Region
Japan

Condition
Condition New Osteoporotic Vertebral Fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects of early mobilization and exercise therapy for patients with osteoporotic vertebral fractures (OVF) on pain relief, improvement of activities of daily living, and influence of fractured vertebral bodies
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Back pain(at admission, 14-day from admission, at discharge)
Key secondary outcomes age
sex
body height
body weight
Body mass index
Level of the fractured vertebral body
Collapse ratio of fractured vertebrae(Quantitative measurement method)(at admission and discharge)
Local kyphotic angle(at admission and discharge)
Bone density
Walking ability (locomotion of Functional Independence Measure)(at pre-injury, admission, and discharge)
Period from injury to hospitalization
Length of hospital stay
Presence of the old vertebral fractures

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with osteoporosis and one or a few new vertebral fractures followinging the 1st thoracic vertebra
Key exclusion criteria Traumatic injury
Having undergone surgical treatment
Fractures that necessitated surgery for neurologic complications or vertebral instability (due to crushed fractures and/or posterior wall injury)
Pathological fractures (due to purulent spondylitis, spinal tumors)
Patients using steroids
Dialysis patients
being bedridden
dementia
Target sample size 109

Research contact person
Name of lead principal investigator
1st name Mamoru
Middle name
Last name Kawakami
Organization Wakayama Medical University Kihoku Hospital
Division name Spine Care Spine
Zip code 649-7113
Address 219 Myoji, Katsuragi-cho, Ito-gun, Wakayama Prefecture
TEL +81736-22-0066
Email kawakami@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Masafumi
Middle name
Last name Nakagawa
Organization Wakayama Medical University Kihoku Hospital
Division name Spine Care Spine
Zip code 649-7113
Address 219 Myoji, Katsuragi-cho, Ito-gun, Wakayama Prefecture
TEL +81736-22-0066
Homepage URL
Email ptnaka@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
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 Wakayama Medical University
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture
Tel +8173-447-2300
Email rinri@wakayama-med.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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 16 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 109
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
2009 Year 12 Month 27 Day
Date of IRB
2019 Year 09 Month 30 Day
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2020 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective study

Management information
Registered date
2020 Year 09 Month 16 Day
Last modified on
2020 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047726

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.