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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044199
Receipt No. R000050341
Scientific Title Can exercise therapy prevent new vertebral fracture and kyphosis after kyphoplasty?
Date of disclosure of the study information 2021/05/13
Last modified on 2021/05/13

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Basic information
Public title Can exercise therapy prevent new vertebral fracture and kyphosis after kyphoplasty?
Acronym Effectiveness of exercise therapy after kyphoplasty
Scientific Title Can exercise therapy prevent new vertebral fracture and kyphosis after kyphoplasty?
Scientific Title:Acronym Effectiveness of exercise therapy after kyphoplasty
Region
Japan

Condition
Condition Osteoporotic vertebral fracture
Classification by specialty
Endocrinology and Metabolism Geriatrics Surgery in general
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify whether exercise therapy can prevent new vertebral fracture and kyphosis after kyphoplasty.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Presence and number of new vertebral fractures
Progression of kyphosis
Presence and number of falls
Key secondary outcomes Bone mineral density
Muscle mass
Physical assessments (Gait speed, Timed up and go test, One-leg standing test)
Cognitive assessment (Mini-Mental State Examination)
Patient-reported outcomes (Numerical rating scale, Oswestry disability index, SF-36, EuroQol 5-Dimension 5-Level)

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
60 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Osteoporotic vertebral fracture
Receiving kyphoplasty
Patients who want to receive outpatient physical therapy for 3 months after kyphoplasty
Key exclusion criteria Traumatic vertebral fracture
Nerve injury
Additional fusion surgery
Previous spine surgery
Cognitive impairment
Psychiatric illness
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yukihiro
Middle name
Last name Nakagawa
Organization Wakayama Medical University Kihoku Hospital
Division name Department of Orthopaedic surgery
Zip code 649-7113
Address 219, Myoji, Katsuragi-cho, Ito-gun, Wakayama
TEL 0736220066
Email yukihiro19670916@gmail.com

Public contact
Name of contact person
1st name Masakazu
Middle name
Last name Minetama
Organization Wakayama Medical University Kihoku Hospital
Division name Department of Rehabilitation
Zip code 649-7113
Address 219, Myoji, Katsuragi-cho, Ito-gun, Wakayama
TEL 0736220066
Homepage URL
Email masakazumasakazu910@hotmail.co.jp

Sponsor
Institute Wakayama medical university
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board at Wakayama Medical University
Address 811-1, Kimiidera, Wakayama city, Japan
Tel 0734472300
Email wa-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
2021 Year 05 Month 13 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
2020 Year 12 Month 19 Day
Date of IRB
2021 Year 04 Month 21 Day
Anticipated trial start date
2021 Year 05 Month 13 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Clinical outcomes are compared between patient participated in outpatient physical therapy or not.

Management information
Registered date
2021 Year 05 Month 13 Day
Last modified on
2021 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050341

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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