UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038872 |
|---|---|
| Receipt number | R000044330 |
| Scientific Title | A longitudinal study of the relationship between physical activity, arterial stiffness and renal function in patients with stable chronic obstructive pulmonary disease. |
| Date of disclosure of the study information | 2019/12/14 |
| Last modified on | 2022/06/22 20:47:51 |
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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
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
gm.ke0202@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044330
