UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046187
Receipt number R000052703
Scientific Title Effect of exercise aimed to avoid the progression of osteoarthritis of hip
Date of disclosure of the study information 2021/12/31
Last modified on 2023/05/31 13:31:34

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Basic information

Public title

Effect of exercise aimed to avoid the progression of osteoarthritis of hip

Acronym

Effect of exercise aimed to avoid the progression of osteoarthritis of hip

Scientific Title

Effect of exercise aimed to avoid the progression of osteoarthritis of hip

Scientific Title:Acronym

Effect of exercise aimed to avoid the progression of osteoarthritis of hip

Region

Japan


Condition

Condition

Osteoarthritis of the hip

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the exercise effect of physical therapy to the patients with hip osteoarthritis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Synergy index of body joints to the center of mass or hip angle

Key secondary outcomes

Harris hip score
Oxford hip score
Visual analog scale of hip pain
gait speed


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Exercise for joint mobility or muscle strength

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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

The patients with hip osteoarthritis who agree with participate to this study

Key exclusion criteria

1. Those who may not understand the contents of this study because of the dementia, psychiatric disease, and so on.
2. Those who have other complication which affect the gait.
3. Those who need a walking aid during gait.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Takuya
Middle name
Last name Ibara

Organization

Tokyo medical and dental university

Division name

Department of functional joint anatomy

Zip code

113-8519

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5390

Email

ibara.fana@tmd.ac.jp


Public contact

Name of contact person

1st name Takuya
Middle name
Last name Ibara

Organization

Tokyo medical and dental university

Division name

Department of functional joint anatomy

Zip code

113-8519

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5390

Homepage URL


Email

ibara.fana@tmd.ac.jp


Sponsor or person

Institute

Tokyo medical and dental university

Institute

Department

Personal name



Funding Source

Organization

JSPS KAKENHI

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

Tokyo medical and dental university

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

Tel

03-3813-6111

Email

syomu1.adm@tmd.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 12 Month 31 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

Enrolling by invitation

Date of protocol fixation

2021 Year 12 Month 31 Day

Date of IRB

2021 Year 12 Month 21 Day

Anticipated trial start date

2022 Year 01 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 11 Month 26 Day

Last modified on

2023 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052703