UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of comprehensive respiratory care program on physical activity and health related quality of life
Title of the study (Brief title)	Impact of comprehensive respiratory care program on physical activity and health related quality of life
Region	Japan

Condition
Condition	chronic respiratory failure
Classification by specialty	Pneumology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is evaluation of comprehensive respiratory care program on physical activity and health related quality of life.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Physical activity and health related quality of life are measured with accelerometer and SF-36.
Key secondary outcomes	Secondary outcome measures 6-minite walk test, mMCR, CAT, SGRQ, STAI, HADS, FAB, BNP, and nutritional status.

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	The patient who will newly start long term oxygen therapy or domiciliary noninvasive pressure ventilation therapy.
Key exclusion criteria	1. The patient who has recieved hospitalization within one month before the examination. 2. The patient who has acute exacerbation of chronic respiratory failure whithin one month before the examination. 3. The patient who has change of medicine for chronic respiratory failure within two weeks before the examination. 4. The patient who has rapid progressive fatal diseases. 5. The heart failure patient with NYHA 4. 6. The patient who judged inappropriate by attending doctor.
Target sample size	20

Research contact person
Name of lead principal investigator	Takamasa Kitajima
Organization	Kitano hospital, the tazuke kofukai medical research institute
Division name	Division of Respiratory Medicine, Respiratory Disease Center
Address	2-4-20 Ougi-machi, Kitaku, Osaka, Japan
TEL	06-6312-1221
Email	m-kitajima@kitano-hp.or.jp

Public contact
Name of contact person	Takamasa Kitajima
Organization	Kitano hospital, the tazuke kofukai medical research institute
Division name	Division of Respiratory Medicine, Respiratory Disease Center
Address	2-4-20 Ougi-machi, Kitaku, Osaka, Japan
TEL	06-6312-1221
Homepage URL
Email	m-kitajima@kitano-hp.or.jp

Sponsor
Institute	Kitano hospital, the tazuke kofukai medical research institute
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)

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	田附興風会医学研究所北野病院 (大阪府) (Kitano hospital, the tazuke kofukai medical research institute)

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 22 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 12 Month 22 Day
Anticipated trial start date	2015 Year 01 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Primary outcome measures accelerometer and SF-36. Secondary outcome measures 6-minite walk test, mMCR, CAT, SGRQ, STAI, HADS, FAB, BNP, and nutritional status.

Management information
Registered date	2015 Year 01 Month 21 Day
Last modified on	2019 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018913