UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044824 |
|---|---|
| Receipt number | R000051198 |
| Scientific Title | Association of physical activity with longitudinal changes in prognostic factors in patients with chronic obstructive pulmonary disease. |
| Date of disclosure of the study information | 2021/07/15 |
| Last modified on | 2021/07/11 09:18:32 |
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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
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
gm.ke0202@gmail.com
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University Wakabayashi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051198
