UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061919 |
|---|---|
| Receipt number | R000070848 |
| Scientific Title | Comparison of exercise limitation factors detected by three field tests including assessment of skeletal muscle function in patients with interstitial lung disease: a comparison of the 6-minute walk test, 1-minute sit-to-stand test, and 6-minute step test |
| Date of disclosure of the study information | 2026/06/16 |
| Last modified on | 2026/06/15 19:05:37 |
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Basic information
Public title
Comparison of exercise limitation factors detected by three field tests including assessment of skeletal muscle function in patients with interstitial lung disease: a comparison of the 6-minute walk test, 1-minute sit-to-stand test, and 6-minute step test
Acronym
Comparison of exercise limitation factors detected by three field tests including assessment of skeletal muscle function in patients with interstitial lung disease: a comparison of the 6-minute walk test, 1-minute sit-to-stand test, and 6-minute step test
Scientific Title
Comparison of exercise limitation factors detected by three field tests including assessment of skeletal muscle function in patients with interstitial lung disease: a comparison of the 6-minute walk test, 1-minute sit-to-stand test, and 6-minute step test
Scientific Title:Acronym
Comparison of exercise limitation factors detected by three field tests including assessment of skeletal muscle function in patients with interstitial lung disease: a comparison of the 6-minute walk test, 1-minute sit-to-stand test, and 6-minute step test
Region
| Japan |
Condition
Condition
Interstitial lung disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to perform the 6-minute walk test, 1-minute sit-to-stand test, and 6-minute step test in the same patients with interstitial lung disease and to clarify the following three points. First, the concurrent validity of the 1-minute sit-to-stand test and the 6-minute step test against the 6-minute walk test will be examined based on the correlations among 6-minute walk distance, the number of repetitions in the 1-minute sit-to-stand test, and the number of steps in the 6-minute step test. Second, the validity of the 1-minute sit-to-stand test and the 6-minute step test for detecting exercise-induced desaturation compared with the 6-minute walk test will be examined. Third, the agreement in exercise limitation factors related to respiratory, circulatory, and skeletal muscle function will be evaluated to determine whether the 1-minute sit-to-stand test and the 6-minute step test can detect exercise limitation factors to a similar extent as the 6-minute walk test.
Basic objectives2
Others
Basic objectives -Others
Validation of assessment methods
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Concurrent validity based on the correlations among the 6-minute walk distance in the 6-minute walk test, the number of repetitions in the 1-minute sit-to-stand test, and the number of steps in the 6-minute step test
2. Validity of the 1-minute sit-to-stand test and the 6-minute step test for detecting exercise-induced desaturation compared with the 6-minute walk test
3. Agreement in exercise limitation factors related to respiratory, circulatory, and skeletal muscle function, namely whether the 1-minute sit-to-stand test and the 6-minute step test can detect exercise limitation factors to a similar extent as the 6-minute walk test
Key secondary outcomes
As exploratory outcomes, the following variables will be collected or assessed:
Patient characteristics: age, sex, height, body weight, body mass index, GAP Index, smoking history, diagnosis, disease history, and medication history.
Blood tests: PaO2, PaCO2, white blood cell count, C-reactive protein, KL-6, and SP-D.
Pulmonary function: VC, %VC, FVC, %FVC, FEV1.0, %FEV1.0, DLco, %DLco, MIP, and MEP.
Dyspnea: modified Medical Research Council dyspnea scale.
Physical function: Short Physical Performance Battery.
Skeletal muscle assessment: grip strength, isometric knee extension strength, skeletal muscle mass, muscle mass, and skeletal muscle index.
Exercise tests: In the 6-minute walk test, 6-minute walk distance, modified Borg Scale scores for dyspnea and lower-limb fatigue, blood pressure, SpO2, respiratory rate, heart rate, tissue oxygen saturation (tissue saturation index: TSI, tissue oxygen saturation: StO2), oxyhemoglobin, deoxyhemoglobin, and total hemoglobin will be assessed. In the 1-minute sit-to-stand test, the number of repetitions, modified Borg Scale scores for dyspnea and lower-limb fatigue, blood pressure, SpO2, respiratory rate, heart rate, tissue oxygen saturation (TSI, StO2), oxyhemoglobin, deoxyhemoglobin, and total hemoglobin will be assessed. In the 6-minute step test, the number of steps, modified Borg Scale scores for dyspnea and lower-limb fatigue, blood pressure, SpO2, respiratory rate, heart rate, tissue oxygen saturation (TSI, StO2), oxyhemoglobin, deoxyhemoglobin, and total hemoglobin will be assessed.
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
Participants will undergo the 6-minute walk test, 1-minute sit-to-stand test, and 6-minute step test. During each test, SpO2 and heart rate will be measured using a pulse oximeter, tissue saturation index (tissue oxygen saturation) of the right vastus lateralis will be assessed using near-infrared spectroscopy, and video recording will be performed to evaluate respiratory rate. Adequate rest will be provided between tests, and the procedures will be performed with priority given to safety while monitoring general condition, respiratory status, SpO2, subjective symptoms, and fatigue. For each participant, measurements will be performed over approximately 1 to 2 days for inpatients and over 2 to 3 days within approximately 1 month for outpatients. The participant's physical condition and clinical schedule will be prioritized, and the assessments may be divided into separate sessions as needed.
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
Patients diagnosed with interstitial lung disease
Patients aged 18 years or older
Patients judged by a physician to be able to participate in the study
Patients with stable interstitial lung disease
Key exclusion criteria
Patients immediately after acute exacerbation of interstitial lung disease
Patients with marked hypoxemia
Patients in whom pulse oximeter measurement is considered unreliable
Patients with orthopedic disease or peripheral neuropathy that prevents performance of the 6-minute walk test, 1-minute sit-to-stand test, or 6-minute step test
Patients in whom bioelectrical impedance body composition assessment may be affected by implanted metal devices, pacemakers, or similar conditions
Patients who do not provide informed consent or who withdraw consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Omura |
Organization
Seirei Christopher University
Division name
Graduate School of Rehabilitation Sciences
Zip code
433-8558
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu, Shizuoka 433-8558, Japan
TEL
053-439-1400
25mr03@g.seirei.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Tawara |
Organization
Seirei Christopher University
Division name
Faculty of Rehabilitation
Zip code
433-8558
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu, Shizuoka 433-8558, Japan
TEL
053-439-1400
Homepage URL
yuichi-t@seirei.ac.jp
Sponsor or person
Institute
Seirei Christopher University
Institute
Department
Personal name
Funding Source
Organization
Seirei Christopher 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
Seirei Christopher University
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu, Shizuoka 433-8558, Japan
Tel
053-439-1400
yuichi-t@seirei.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
26-085
Org. issuing International ID_1
Hamamatsu University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
浜松医科大学医学部附属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2026 | Year | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070848
