UMIN-CTR Clinical Trial

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