UMIN-CTR Clinical Trial

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
Institute	Tohoku University
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044330