UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038872
Receipt number R000044330
Scientific Title A longitudinal study of the relationship between physical activity, arterial stiffness and renal function in patients with stable chronic obstructive pulmonary disease.
Date of disclosure of the study information 2019/12/14
Last modified on 2022/06/22 20:47:51

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Basic information

Public title

A longitudinal study of the relationship between physical activity, arterial stiffness and
renal function in patients with stable chronic obstructive pulmonary disease.

Acronym

Study on the relationship between physical activity, arterial stiffness and renal function
in patients with stable chronic obstructive pulmonary disease.

Scientific Title

A longitudinal study of the relationship between physical activity, arterial stiffness and
renal function in patients with stable chronic obstructive pulmonary disease.

Scientific Title:Acronym

Study on the relationship between physical activity, arterial stiffness and renal function
in patients with stable chronic obstructive pulmonary disease.

Region

Japan


Condition

Condition

chronic obstructive pulmonary disease

Classification by specialty

Pneumology Nephrology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to elucidate the influence of physical activity on arterial stiffness and renal function in patients with stable chronic obstructive pulmonary disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.renal function
2.arterial stiffness

Key secondary outcomes

1.ankle-brachial pressure index
2.blood biochemical examination
3.physical function
4.body composition


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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients diagnosed with chronic obstructive pulmonary disease.
2.Patients followed up at the hospital (Tohoku Medical and Pharmaceutical University Wakabayashi Hospital.) for 1 year.
3.Patients written informed consent in this study.

Key exclusion criteria

1.Patients need home oxygen therapy during the study period.
2.Patients had exacerbation of chronic obstructive pulmonary disease within the follow-up evaluation period at the time of enrollment or within 8 weeks of recovery from exacerbation.
3.Patients dependent in Activities of Daily Living
4.Hemodialysis(HD)patients.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Kohzuki

Organization

Tohoku University

Division name

Graduate School of Medicine

Zip code

980-8574

Address

1-1, Seiryo-cho, Aoba-ku, Sendai

TEL

022-717-7351

Email

kohzuki@med.tohoku.ac.jp


Public contact

Name of contact person

1st name takeshi
Middle name
Last name kobayashi

Organization

Tohoku University

Division name

Graduate School of Medicine

Zip code

980-8574

Address

1-1, Seiryo-cho, Aoba-ku, Sendai

TEL

090-6452-5993

Homepage URL


Email

gm.ke0202@gmail.com


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Not receive funds

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

Tohoku University

Address

1-1, Seiryo-cho, Aoba-ku, Sendai

Tel

022-717-8006

Email

med-kenkyo@grp.tohoku.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

2019 Year 12 Month 14 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

Completed

Date of protocol fixation

2019 Year 11 Month 16 Day

Date of IRB

2019 Year 11 Month 25 Day

Anticipated trial start date

2019 Year 12 Month 01 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is observational prospective study.
We will investigate physical activity and changes of arterial stiffness, renal function and during 12 months in patients with stable chronic obstructive pulmonary disease.
In addition, patient characteristics will be investigated for relevant factors.


Management information

Registered date

2019 Year 12 Month 13 Day

Last modified on

2022 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044330


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name