UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052704 |
|---|---|
| Receipt number | R000060129 |
| Scientific Title | The study of association between skeletal muscle and gut microbiota in patients with COPD |
| Date of disclosure of the study information | 2023/11/06 |
| Last modified on | 2025/05/08 09:17:21 |
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Basic information
Public title
The study of association between skeletal muscle and gut microbiota in patients with COPD
Acronym
COPD-Savior: Saga physical activity and gut environmental project
Scientific Title
The study of association between skeletal muscle and gut microbiota in patients with COPD
Scientific Title:Acronym
COPD-Savior: Saga physical activity and gut environmental project
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the relationship between gut microbiota and skeletal muscle in patients with COPD; to analyze the effects of rehabilitation-induced skeletal muscle exercise on COPD patients and the changes in short-chain fatty acids and gut microbiota in this process.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the amount of change in body composition (upper limb muscle mass, lower limb muscle mass, trunk muscle mass, and phase angle) and the diversity of the gut microbiota between baseline and 12 weeks later
Key secondary outcomes
(1) Baseline and 12-week change in the following
Percentage of achievement of individually defined target number of steps per day after 12 weeks
Change in 6-minute walk distance(6MWD)
Percentage of patients achieving a minimum clinical effective improvement of 30 m in 6-minute walk distance(6MWD).
Change in number of steps per day
Change in physical activity (1.0-1.5 METs, 2.0 METs or more, 3.0 METs or more activity time)
Change in body composition (upper limb muscle mass, lower limb muscle mass, trunk muscle mass, phase angle)
Changes in myokines (IL-6, myostatin, BDNF, irisin)
Changes in blood short-chain fatty acids
Changes in diversity of intestinal microflora (Chao 1 index, Shannon index, Simpson index) and bacterial species
(2) Examination of factors related to the following items, relationships among items, and relationships with other factors when divided into two counties by median values
Whether or not the goal of the number of daily walks was achieved.
Change in the number of daily walks
Change in physical activity (1.0-1.5 METs, 2.0 METs or more, 3.0 METs or more activity time)
Changes in body composition (upper limb muscle mass, lower limb muscle mass, trunk muscle mass, phase angle)
Changes in myokines (IL-6, myostatin, BDNF, irisin)
Changes in blood short-chain fatty acids
Changes in diversity of intestinal microflora (Chao 1 index, Shannon index, Simpson index)
Changes in species of intestinal microflora
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
Inclusion Criteria:
1. patients with COPD over 40 years of age.
2. male and female
3. smoking history
4. FEV1 less than 0.7 after bronchodilator administration.
5. No history of COPD exacerbation requiring hospitalization in the past 12 months.
6. has received COPD treatment with inhaled long-acting anticholinergics (LAMA), inhaled long-acting beta2-stimulants (LABA), inhaled steroids (ICS), xanthine, expectorants, or other medications.
Key exclusion criteria
Exclusion criteria:
1. Patients who have undergone inpatient or outpatient induction or maintenance respiratory rehabilitation in the past 12 months.
2. Women of childbearing potential, pregnant or lactating during the study period, or planning to become pregnant.
3. Patients who are unable to undergo pulmonary function tests.
4. Patients who have experienced an acute respiratory infection (e.g., pneumonia) or moderate/severe COPD exacerbation within 4 weeks prior to screening
5. Patients with other serious comorbidities.
6. patients with malignant tumors requiring treatment.
7. Patients with other chronic respiratory diseases (bronchiectasis, interstitial pneumonia or pneumoconiosis).
8. Patients who have been identified as inappropriate subjects for this study (e.g., dementia, psychiatric disorders, cerebrovascular disease with paralysis, etc.). Consent will be obtained based on the patient's own consent, and consent by other guardians or proxies will not be accepted.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Takahashi |
Organization
Saga university hospital
Division name
Division of Respiratory medicine
Zip code
8498501
Address
5-1-1, Nabeshima, Saga
TEL
0952342360
takahak@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Clinical research center |
| Middle name | |
| Last name | Saga university hospital |
Organization
Saga university hospital
Division name
Clinical research center
Zip code
8498501
Address
5-1-1, Nabeshima, Saga
TEL
0952343400
Homepage URL
kenkyu-shinsei@ml.cc.saga-u.ac.jp
Sponsor or person
Institute
Saga university hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga university hospital
Address
5-1-1, Nabeshima, Saga
Tel
0952343400
kenkyu-shinsei@ml.cc.saga-u.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
| 2023 | Year | 11 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060129
