UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028970
Receipt number R000033148
Scientific Title The effect of physical therapy to the fraility patients with osteoporosis.
Date of disclosure of the study information 2017/09/03
Last modified on 2020/09/04 12:46:35

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Basic information

Public title

The effect of physical therapy to the fraility patients with osteoporosis.

Acronym

The effect of physical therapy to the fraility patients with osteoporosis.

Scientific Title

The effect of physical therapy to the fraility patients with osteoporosis.

Scientific Title:Acronym

The effect of physical therapy to the fraility patients with osteoporosis.

Region

Japan


Condition

Condition

Elderly fraility patients with osteoporosis.

Classification by specialty

Geriatrics Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the efficiency of physical therapy to the elderly fraility patients with osteoporosis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fraility basic check list in Japan

Key secondary outcomes



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

Behavior,custom

Interventions/Control_1

We conduct physical therapy to the fraility patients once at inclusion, and evaluated the improvement of fraility after 6 months and 12 months.

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

30 years-old <

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Fraility patients with osteoporosis without dimentia.

Key exclusion criteria

The patients without assent, and dimentia

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Norio
Middle name
Last name Imai

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Comprehensive Geriatrics in Community,

Zip code

9518510

Address

1-757, Asahimachidori, Niigata Pref., Niigata City, Japan.

TEL

0252272272

Email

imainorio2001@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Norio
Middle name
Last name Imai

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Comprehensive Geriatrics in Community,

Zip code

9518510

Address

1-757, Asahimachidori, Niigata Pref., Niigata City, Japan.

TEL

0252272272

Homepage URL


Email

imainorio2001@med.niigata-u.ac.jp


Sponsor or person

Institute

Division of Comprehensive Geriatrics in Community, Niigata University Graduate School of Medical and Dental Sciences

Institute

Department

Personal name



Funding Source

Organization

Division of Comprehensive Geriatrics in Community, Niigata University Graduate School of Medical and Dental Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Niigata University

Address

1-757, Asahimachidori, Niigata Pref., Niigata City, Japan.

Tel

0252272272

Email

imainorio2001@yahoo.co.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

2017 Year 09 Month 03 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

Preinitiation

Date of protocol fixation

2017 Year 09 Month 03 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 03 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 01 Day

Date trial data considered complete

2020 Year 03 Month 01 Day

Date analysis concluded

2020 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2017 Year 09 Month 02 Day

Last modified on

2020 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033148


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name