UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044824
Receipt number R000051198
Scientific Title Association of physical activity with longitudinal changes in prognostic factors in patients with chronic obstructive pulmonary disease.
Date of disclosure of the study information 2021/07/15
Last modified on 2021/07/11 09:18:32

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Basic information

Public title

Association of physical activity with longitudinal changes in prognostic factors in patients with chronic obstructive pulmonary disease.

Acronym

Association of physical activity with prognostic factors in patients with chronic obstructive pulmonary disease.

Scientific Title

Association of physical activity with longitudinal changes in prognostic factors in patients with chronic obstructive pulmonary disease.

Scientific Title:Acronym

Association of physical activity with prognostic factors in patients with chronic obstructive pulmonary disease.

Region

Japan


Condition

Condition

chronic obstructive pulmonary disease.

Classification by specialty

Pneumology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Some parameters have been reported as factors contributing to the prognosis of patients with chronic obstructive pulmonary disease, including acute exacerbations, depression, exercise tolerance, airflow limitation, and sarcopenia. In recent years, new prognostic parameters such as phase angle and renal function have also been reported. The purpose of this study is to investigate the relationship between changes in those parameters and changes in physical activity and sedentary behavior , and to identify the factors most relevant to the prognosis of patients with chronic obstructive pulmonary disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To extract prognostic factors for COPD patients.

Key secondary outcomes

Changes in renal function
Changes in phase angle
Changes in arterial stiffness
Changes in ankle-brachial pressure index
Changes in physical function
Relationship between prognosis and physical activity


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

who have been diagnosed with chronic obstructive pulmonary disease by a doctor.

who can be followed up at the hospital (Tohoku Medical and Pharmaceutical University Wakabayashi Hospital.) for 1 year.

Key exclusion criteria

who are activity of daily living is dependent

who are judged by the attending physician to be inappropriate as research subjects.

Target sample size

190


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Kobayashi

Organization

Tohoku Medical and Pharmaceutical University Wakabayashi Hospital

Division name

Rehabilitation

Zip code

9840042

Address

2-29-1 Yamato-machi, Wakabayashi-ku, Sendai City, Miyagi Prefecture

TEL

022-236-5976

Email

gm.ke0202@gmail.com


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Kobayashi

Organization

Tohoku Medical and Pharmaceutical University Wakabayashi Hospital

Division name

Rehabilitation

Zip code

9840042

Address

2-29-1 Yamato-machi, Wakabayashi-ku, Sendai City, Miyagi Prefecture

TEL

022-236-5976

Homepage URL


Email

gm.ke0202@gmail.com


Sponsor or person

Institute

Tohoku Medical and Pharmaceutical University Wakabayashi Hospital

Institute

Department

Personal name



Funding Source

Organization

not

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 Medical and Pharmaceutical University Wakabayashi Hospital

Address

2-29-1 Yamato-machi, Wakabayashi-ku, Sendai City, Miyagi Prefecture

Tel

022-236-5976

Email

gm.ke0202@gmail.com


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 07 Month 15 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

2020 Year 08 Month 13 Day

Date of IRB

2021 Year 05 Month 20 Day

Anticipated trial start date

2020 Year 09 Month 01 Day

Last follow-up date

2027 Year 08 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.
Patients with the stable chronic obstructive pulmonary disease will be followed for 5 years to determine the parameters related to prognosis of life. Physical activity, physical function, renal function, and phase angle will be investigated every 6 months, and respiratory function and vascular function every 12 months. Other relevant factors to be investigated include background factors (age, gender, comorbidities, medication status, etc.), blood and biochemical tests, and urinalysis.


Management information

Registered date

2021 Year 07 Month 11 Day

Last modified on

2021 Year 07 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051198


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name