UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041808 |
|---|---|
| Receipt number | 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 09:04:40 |
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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
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
ptnaka@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047726
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
