UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044199
Receipt number 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 2023/11/14 15:24:58

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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 or person

Institute

Wakayama medical university

Institute

Department

Personal name



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

2025 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

2023 Year 11 Month 14 Day



Link to view the page

Value
https://center6.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