UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055822 |
|---|---|
| Receipt number | R000063799 |
| Scientific Title | A study on the quantitative evaluation of breathing patterns and gait strategies during the 6-minute walk test in patients with interstitial lung disease. |
| Date of disclosure of the study information | 2024/10/14 |
| Last modified on | 2025/10/14 12:33:37 |
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Basic information
Public title
A study on the quantitative evaluation of breathing patterns and gait strategies during the 6-minute walk test in patients with interstitial lung disease.
Acronym
A study on the quantitative evaluation of breathing patterns and gait strategies during the 6-minute walk test in patients with interstitial lung disease.
Scientific Title
A study on the quantitative evaluation of breathing patterns and gait strategies during the 6-minute walk test in patients with interstitial lung disease.
Scientific Title:Acronym
A study on the quantitative evaluation of breathing patterns and gait strategies during the 6-minute walk test in patients with interstitial lung disease.
Region
| Japan |
Condition
Condition
Interstitial lung disease, chronic obstructive pulmonary disease, bronchial asthma, bronchiectasi
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to conduct a quantitative evaluation of gait during the 6-minute walk test in patients with interstitial lung disease using acceleration data, and to clarify the relationship between changes in breathing patterns and physiological data during the test, as well as the corresponding gait strategies.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of this study is to evaluate the correlation between composite acceleration (integrated from the XYZ axes) and respiratory rate, as well as oxygen saturation (SpO2). Specifically, the study aims to clarify how composite acceleration, which captures the overall magnitude and stability of movement during the 6-minute walk test, relates to respiratory function during exercise.
Key secondary outcomes
The secondary endpoints will involve comparisons with other respiratory diseases, such as COPD. This will allow for the analysis of differences between disease groups in terms of walking ability and respiratory function (average respiratory rate, IE ratio). Specifically, by comparing changes in gait patterns and respiratory parameters associated with each condition, the study aims to quantitatively evaluate disease-specific exercise limitations and respiratory dysfunction. The following items will be assessed:
Walking ability
1. Changes in gyroscope data (XYZ axes) during walking
2. Magnetic field changesector Magnitude Unit (VMU)
3. Step count
4. Average stride length
5. Cadence
Respiratory function during walking
1. IE ratio (Inhalation/Exhalation ratio)
2. Heart rate
3. Number of inhalations and exhalations
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. Male patients aged 20 years or older
2. Patients who provide written consent to participate in this study
3. Inpatients or outpatients of Gunma University Hospital
4. Patients diagnosed with one of the following conditions:
1) Patients diagnosed with interstitial lung disease (ILD)
2) Patients diagnosed with chronic obstructive pulmonary disease (COPD)
3) Patients diagnosed with bronchial asthma
4) Patients diagnosed with bronchiectasis
Key exclusion criteria
1. Those who have experienced acute exacerbation within 4 weeks prior to consent
2. Those with unstable cardiovascular disease
3. Those who require walking aids for ambulation
4. Those with orthopedic or neurological conditions that may affect the evaluation of exercise tolerance
5. Those using home oxygen therapy
6. Those unable to provide consent or understand explanations due to cognitive impairment or psychiatric symptoms
7. Those using a pacemaker or implantable defibrillator
8. Those unable to wear the devices used in the study
Target sample size
60
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
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational comparative study. This study will target COPD and ILD patients who meet the selection criteria from among the respiratory disease patients hospitalized or attending outpatient clinics at Gunma University Hospital. The study period will be from the time of approval by the ethics review committee until March 31, 2029. The measurement items will include step count, stride length, cadence (walking rhythm), and respiratory physiological data (respiratory rate, SpO2, heart rate, and IE ratio) during the 6-minute walk test. Additionally, the study will assess the variability in respiratory rate and walking patterns on a minute-by-minute basis, changes in thoracic angular velocity, and thoracic mobility and respiratory function using the ResMo device. The aim is to analyze the differences in respiratory function and gait patterns between COPD and ILD patients, and to clarify the characteristics of exercise function and respiratory function specific to each disease.
Management information
Registered date
| 2024 | Year | 10 | Month | 13 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063799
