UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016300 |
|---|---|
| Receipt number | R000018913 |
| Scientific Title | Impact of comprehensive respiratory care program on physical activity and health related quality of life |
| Date of disclosure of the study information | 2015/01/22 |
| Last modified on | 2019/01/25 14:42:02 |
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Basic information
Public title
Impact of comprehensive respiratory care program on physical activity and health related quality of life
Acronym
Impact of comprehensive respiratory care program on physical activity and health related quality of life
Scientific Title
Impact of comprehensive respiratory care program on physical activity and health related quality of life
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takamasa Kitajima |
Organization
Kitano hospital, the tazuke kofukai medical research institute
Division name
Division of Respiratory Medicine, Respiratory Disease Center
Zip code
Address
2-4-20 Ougi-machi, Kitaku, Osaka, Japan
TEL
06-6312-1221
m-kitajima@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamasa Kitajima |
Organization
Kitano hospital, the tazuke kofukai medical research institute
Division name
Division of Respiratory Medicine, Respiratory Disease Center
Zip code
Address
2-4-20 Ougi-machi, Kitaku, Osaka, Japan
TEL
06-6312-1221
Homepage URL
m-kitajima@kitano-hp.or.jp
Sponsor or person
Institute
Kitano hospital, the tazuke kofukai medical research institute
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2014 | Year | 12 | Month | 22 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018913
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
