UMIN-CTR Clinical Trial

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
Institute	Tohoku Medical and Pharmaceutical University Wakabayashi Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051198