UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050745 |
|---|---|
| Receipt number | R000057821 |
| Scientific Title | The evaluation of physical activity and sedentary behavior and their related factors in patients with COPD. |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/03/14 10:07:40 |
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Basic information
Public title
The evaluation of physical activity and sedentary behavior and their related factors in patients with COPD.
Acronym
The evaluation of physical activity and sedentary behavior and their related factors in patients with COPD.
Scientific Title
The evaluation of physical activity and sedentary behavior and their related factors in patients with COPD.
Scientific Title:Acronym
The evaluation of physical activity and sedentary behavior and their related factors in patients with COPD.
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the differences in the profile of COPD patients classified by physical activity and sedentary time.
Basic objectives2
Others
Basic objectives -Others
1. To Clarify the factors associated with phenotypes classified by physical activity and sedentary behavior in COPD patients.
2. Evaluation of an accelerometer-based measurement method in COPD patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the factors that determine the phenotype of COPD patients classified by physical activity and sedentary behavior.
Key secondary outcomes
Assessment of the validity of an accelerometer-based measurement method for physical activity and sedentary behavior in COPD patients.
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
Outpatients with stable COPD diagnosed with forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) <0.7 after bronchodilator administration.
Key exclusion criteria
1.Clinically relevant bronchial asthma
2.Receiving oxygen therapy
3.A history of lung resection
4.A history of exacerbation within three months
5.Physical activity extremely suppressed by other diseases (including neuromuscular disease, bone and joint disease, active malignant disease, myocardial infarction, etc.)
6.Participation in this study deemed inappropriate by the attending physician.
Target sample size
253
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Murakami |
Organization
National Hospital Organization Wakayama Hospital
Division name
Respiratory Medicine
Zip code
644-0044
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama
TEL
0738-22-3256
murakamiy0606@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Murakami |
Organization
National Hospital Organization Wakayama Hospital
Division name
Respiratory Medicine
Zip code
644-0044
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama
TEL
0738-22-3256
Homepage URL
murakamiy0606@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Wakayama Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Wakayama Hospital
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
National Hospital Organization Wakayama Hospital
Address
1138 Wada, Mihama-cho, Hidaka-gun, Wakayama
Tel
0738-22-3256
inoue.atsuyuki.nx@mail.hosp.go.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
| 2023 | Year | 04 | Month | 01 | 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
| 2023 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On day 0, patient information such as age, gender, smoking history, mMRC, Hospital Anxiety Scale, depression assessment scale (HADS), and medical history are recorded. Additionally, evaluations are done on body mass index (BMI), nutritional status, grip strength, pulmonary function tests after bronchodilator administration, and blood tests. The medical history includes the use of COPD medications, bronchodilators, and the presence of any complications. Nutritional status is evaluated by measuring the arm circumference and subcutaneous fat thickness of the triceps. The blood test includes evaluations of red blood cells, hemoglobin, fasting blood glucose, hemoglobin A1c, albumin, and brain natriuretic peptide. On day 14 (or up to day 28), a six-minute walk test (6MWT) is conducted.
From day 0 to day 14 (or up to day 28), physical activity is measured for 24 hours a day, except during bathing and swimming, using a triaxial accelerometer, Active Style Pro HJA-750C (Omron Healthcare, Kyoto, Japan), and recorded in a diary. Duration of activity at or above 3.0 MET is used as an indicator of physical activity, and duration of activity between 1.0-1.5 MET is used as an indicator of sedentary behavior.
Days affected by rain, special activities, or with an average temperature below 2.5 degrees, which are thought to affect the patient's physical condition, are excluded from analysis on day 15. Data measured by the accelerometer is extracted from 7:00 to 20:00 and days with less than 10 hours of accelerometer wear time are excluded. Finally, data from patients with at least 3 valid days are analyzed. Information regarding weather and special activity days is obtained from the diary. The average temperature is detected from records of the nearest weather observation station to the facility where the patient was recruited.
Management information
Registered date
| 2023 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057821
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