UMIN-CTR Clinical Trial

Basic information
Public title	Actual state of constipation and its factors in patients with chronic respiratory failure
Acronym	Chronic respiratory failure and constipation
Scientific Title	Actual state of constipation and its factors in patients with chronic respiratory failure
Scientific Title:Acronym	Chronic respiratory failure and constipation
Region	Japan

Condition
Condition	Chronic respitory failure
Classification by specialty	Medicine in general Pneumology Geriatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the frequency and severity of constipation in patients with chronic respiratory failure, and the relationship between activity and respiratory status and constipation.
Basic objectives2	Others
Basic objectives -Others	It may be possible to clarify the need for interventions such as defecation control by investigating the occurrence of constipation and subjective symptoms associated with constipation.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Current bowel pattern and properties (Bristol scale) Severity of constipation (Constipation Scoring System) Effect of constipation on quality of life (JPAC-QOL) The time when became aware of constipation
Key secondary outcomes	Existence of shortness of breath during excretion Difficulty breathing, comfort, and security when bowel movements are good or bad (constipation) (Borg scale and VAS) Health-related quality of life (SRI) for patients with chronic respiratory failure Current activity Anxiety and depression assessment (HAD) Questionnaires such as sleep quality (PSQI) Basic diseases, age, sex, height, weight, oxygen flow rate, presence or absence of NPPV use, spirometry, 6-minute walking test, various blood test data including blood gas, constipation medication Frequency and type of medication, dosage details other than constipation medication

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic respiratory failure. Underling disease do not matter (COPD, Interstitial pneumoniae, Nontuberculous mycobacteriosis, Bronchiectasis, etc.) Previous treatment do not matter. There is no limitation with laboratory data.
Key exclusion criteria	Clinically Unstable
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hisae Middle name Last name Sano
Organization	National Hospital Organization Minami Kyoto Hospital
Division name	Nursing department
Zip code	610-0113
Address	Naka Ashihara 11, Joyo city, Kyoto, Japan
TEL	0774-52-0065
Email	kensukesumi@gmail.com

Public contact
Name of contact person	1st name Kensuke Middle name Last name Sumi
Organization	National Hospital Organization Minami Kyoto Hospital
Division name	Department of Respiratory Medicine
Zip code	610-0113
Address	Naka Ashihara 11, Joyo city, Kyoto, Japan
TEL	0774-52-0065
Homepage URL
Email	kensukesumi@gmail.com

Sponsor
Institute	Department of Respiratory Medicine, National Hospital Organization Minami-Kyoto Hospital
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine, National Hospital Organization Minami-Kyoto Hospital
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	National Hospital Organization Minami Kyoto Hospital
Address	Naka Ashihara 11, Joyo city, Kyoto, Japan
Tel	0774-52-0065
Email	kensukesumi@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	2020 Year 05 Month 04 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	No longer recruiting
Date of protocol fixation	2020 Year 04 Month 27 Day
Date of IRB	2020 Year 04 Month 27 Day
Anticipated trial start date	2020 Year 04 Month 27 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Conduct a simple questionnaire survey that is an extension of daily clinical practice. Collect patient information from electronic medical records.

Management information
Registered date	2020 Year 05 Month 04 Day
Last modified on	2020 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045986

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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