UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050820 |
|---|---|
| Receipt number | R000057823 |
| Scientific Title | The Effect of Respiratory Rehabilitation on Systemic Inflammation in COPD - Myokine Action and Muscle-Bone Crosstalk - |
| Date of disclosure of the study information | 2023/04/30 |
| Last modified on | 2025/04/14 12:45:02 |
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Basic information
Public title
The Effect of Respiratory Rehabilitation on Systemic Inflammation in COPD - Myokine Action and Muscle-Bone Crosstalk -
Acronym
The Effect of Respiratory Rehabilitation on Systemic Inflammation in COPD - Myokine Action and Muscle-Bone Crosstalk -
Scientific Title
The Effect of Respiratory Rehabilitation on Systemic Inflammation in COPD - Myokine Action and Muscle-Bone Crosstalk -
Scientific Title:Acronym
The Effect of Respiratory Rehabilitation on Systemic Inflammation in COPD - Myokine Action and Muscle-Bone Crosstalk -
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to determine the effect of exercise on systemic inflammation in patients with chronic obstructive pulmonary disease by investigating blood levels of serum myokine including irisin, serum vitamin D, and inflammatory markers, pre and post exercise intervention. This study will also focus on skeletal muscle-bone interactions to determine the role of muscle-bone crosstalk.
Basic objectives2
Others
Basic objectives -Others
Secondary endpoints will include changes in pulmonary functional tests, blood tests, and exercise tolerance (step count and 6-minute walking test).
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
The primary endpoints of this study will be the difference in blood levels of serum Irisin, and serum 25(OH)D levels at 1) pre-exercise intervention, 2) post-short-term exercise intervention, and 3) post-long-term exercise intervention.
Serum Irisin and serum 25(OH)D from the three time periods will be analyzed by two-way ANOVA to confirm the interaction and perform the corresponding multiple comparison tests. A two-sided p-value of 0.05 or less is considered statistically significant in the statistical test.
Key secondary outcomes
The following items will be compared at 1) pre-exercise intervention, 2) post-short-term exercise intervention, and 3) post-long-term exercise intervention.
1. Pulmonary function test
Vital Capacity,Tidal Volume,Expiratory Reverse Volume,Inspiratory Reverse Volume ,Inspiratory Capacity,Forced Vital Capacity (FVC), Forced expiratory volume in 1 second (FEV1),FEV1 as percent of FVC (FEV1/FVC), Maximal Voluntary Ventilation,Peak expiratory flow, FEF25-75%,Maximal expiratory pressure,Maximal expiratory pressure.Pulmonary function test parameters will be expressed as a percentage of actual values and expected values.
2. Blood test data
Hematocrit, hemoglobin, erythrocyte count, mean erythrocyte volume, mean erythrocyte hemoglobin volume, mean erythrocyte hemoglobin concentration, red blood cell distribution width, white blood cell count, white blood cell fraction, neutrophil count, eosinophil count, basophil count, monocyte count, lymphocyte count, platelet count.
3. Biochemical test date
Total protein, total bilirubin, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase, gamma glutamyl transpeptidase, cholinesterase, creatine kinase, amylase, uric acid, urea nitrogen, creatinine sodium, potassium, chlor, calcium, blood glucose, total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, Chyl degree, hemolysis rate, eGFR.
4.Blood Concentration of Serum Myokine
Myostatin, BDNF, SPARC, interleukin (IL)-6, IL-7, IL-15, FGF-21, LIF, IGF-1, Fst, Fstl-1, OSM
5. 6-minute walking distance
6. Number of steps per day
7. Brief-type self-administered diet history questionnaire
8. Sun exposure evaluation score
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
To investigate the effect of exercise intervention in COPD patients, we will compare each item between 1) pre-intervention survey, 2) after short-term exercise intervention, and 3) after long-term exercise intervention.
1) Pre-exercise intervention survey
Pulmonary function tests using a spirometer will be performed prior to the exercise intervention. In addition, blood samples will be collected to evaluate blood test items, biochemical test items, serum Myokine including Irisin, and serum 25(OH)D levels.
2) Short-term exercise intervention
In this study, the 6-minute walk test will be used as a short-term exercise intervention. After the test, blood samples will be collected to evaluate blood tests, biochemical tests, serum Myokine including irisin, and serum 25(OH)D levels.
3) Long-term exercise intervention
Short-term exercise intervention will be followed by long-term exercise intervention. For the long-term exercise intervention, participants will exercise at 60% intensity, 20 to 30 minutes per session, 2 to 3 times per week for 5 weeks at home. The exercise intervention will not be conducted every day, but a total of 15 exercise sessions will be continued.
For the exercise intensity setting, the walking speed will be calculated using the 6-minute walking test obtained after the short-term exercise intervention. The calculated walking speed is assumed to be the maximum walking speed of the research subjects, and 60% of the walking speed is set as the exercise intensity. The subjects will be given the exercise time (20 to 30 minutes), the walking distance calculated from the walking speed (60%), and the number of steps taken according to their stride length.The stride length of the subject is calculated by [height x 0.45 = stride length].
After the 5-week exercise intervention, a 6-minute walk test will be conducted again, and subsequent blood tests, biochemical tests, serum Myokine including Irisin, and serum 25(OH)D levels will be evaluated.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients 18 years of age or older.
2. Patients who give written consent to participate in this study.
3. Outpatients attending Gunma University Hospital or a collaborating study institution.
4. Patients diagnosed with chronic obstructive pulmonary disease.
Key exclusion criteria
1. Patients who need assistance from others when moving indoors, and who need a walking aid other than a cane or drip stand when walking.
2. Patients who have had a short-term exacerbation within the past 4 weeks of the study entry, according to the GOLD definition.
3. Patients with blood sputum of unknown cause.
4. Patients with angina pectoris, unstable cardiovascular disease, or aortic aneurysm.
5. Patients diagnosed with myocardial infarction or pulmonary embolism
6. Have undergone eye surgery (cataract or glaucoma) within the past 4 weeks from the date of study entry.
7. Underwent thoracic or abdominal surgery within the past 4 weeks from the date of study entry.
8. Those who are unable to give explanation and consent due to cognitive functional aspects or psychiatric symptoms.
9. Those who need anti-inflammatory drugs (oral steroids, NSAIDs, etc.) as treatment.
10. Patients who cannot discontinue active vitamin D3 preparations for the treatment of osteoporosis.
11. Regular use of vitamins, protein drinks, amino acids, or other beverages or supplements in the past month.
12. Patients with chronic kidney disease whose urinalysis shows proteinuria of 0.15 g/gcr or more, or whose eGFR is less than 60 mL/min/1.73 m2, or both have persisted for more than 3 months. Patients with chronic kidney disease or other renal diseases.
13. Patients with a diagnosis of liver dysfunction such as acute hepatitis, chronic hepatitis, fatty liver, cirrhosis, etc.
14. Patients who have regularly exercised for at least 60 minutes every week for at least 3 METs of breathless and sweaty exercise, such as running or water exercise, during the past 3 months.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hisada |
Organization
Gunma University
Division name
Graduate School of Health Sciences / Department of Respiratory Medicine and Allergy
Zip code
371-8511
Address
3-39-22, Showa-machi, Maebashi, Gunma
TEL
027-220-8944
hisadat@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hisada |
Organization
Gunma University
Division name
Graduate School of Health Sciences / Department of Respiratory Medicine and Allergy
Zip code
371-8511
Address
3-39-22, Showa-machi, Maebashi, Gunma
TEL
027-220-8944
Homepage URL
hisadat@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jobu Hospital for Respiratory Disease
Tone Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15, Showa-machi, Maebashi, Gunma
Tel
027-220-8740
gunmaciru-office@umin.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
群馬大学保健学研究科（群馬県）、群馬大学医学部附属病院（群馬県）、上武呼吸器内科病院（群馬県）、利根中央病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 30 | 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
| 2023 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057823
