UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061605 |
|---|---|
| Receipt number | R000070484 |
| Scientific Title | Establishment of an Evaluation Method for Muscle Oxygen Dynamics during the 2-Minute Walk Test |
| Date of disclosure of the study information | 2026/05/20 |
| Last modified on | 2026/05/17 21:08:03 |
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Basic information
Public title
Establishment of an Evaluation Method for Muscle Oxygen Dynamics during the 2-Minute Walk Test
Acronym
NIRS-2MWT Study
Scientific Title
Establishment of an Evaluation Method for Muscle Oxygen Dynamics during the 2-Minute Walk Test
Scientific Title:Acronym
NIRS-2MWT Study
Region
| Japan |
Condition
Condition
Parkinson's disease, Healthy adults (including frailty and sarcopenia)
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the cardiopulmonary-muscle linkage during the 2-minute walk test from the perspective of oxygen transport, to build exercise physiological baseline data, and to establish a method for evaluating muscle aerobic capacity using near-infrared spectroscopy (NIRS) applicable to patients with neurological diseases such as Parkinson's disease.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in muscle oxygen saturation (SmO2) of the tibialis anterior and gastrocnemius measured by NIRS during the 2-minute walk test
Key secondary outcomes
1.Muscle aerobic capacity by NIRS during maximal isometric ankle dorsiflexion (oxygenated/deoxygenated hemoglobin dynamics) 2.Physical cost index (PCI) 3.Pulmonary function (VC, FEV1, FEV1%) 4.Grip strength (bilateral) 5.Maximum calf circumference (bilateral) 6.SPPB (Short Physical Performance Battery) 7.MMSE (cognitive screening) 8.Assessements For PD patients: H&Y staging, MDS-UPDRS (Parts I-IV), LEDD, Parkinson Fatigue Scale
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Parkinson's disease: Patients with Parkinson's disease currently undergoing physiotherapy at Hyogo Prefectural Rehabilitation Nishi-Harima Hospital; those capable of walking and performing activities of daily living independently or with supervision; those who have provided written consent. Healthy elderly participants: Aged 65 years or older; with normal cognitive function (MMSE score of 24 or higher); independent in activities of daily living; and free from any cardiopulmonary, musculoskeletal, neuromuscular or malignant conditions that would impede a 2-minute walk test. Young healthy adults: Students at Takarazuka Medical University who have consented to participate in the study.
Key exclusion criteria
Individuals with other brain, musculoskeletal, cardiac, or respiratory conditions that affect walking / Individuals who cannot provide informed consent to participate in the study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Marumoto |
Organization
Hyogo Prefectural Rehabilitation Hospital at Nishi-Harima
Division name
Department of Rehabilitation Medicine/ Neurology
Zip code
679-5165
Address
1-7-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL
+81-791-58-1050
k.maru5081@gmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Marumoto |
Organization
Hyogo Prefectural Rehabilitation Hospital at Nishi-Harima
Division name
Department of Rehabilitation Medicine/ Neurology
Zip code
679-5165
Address
1-7-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL
+81-791-58-1050
Homepage URL
k.maru5081@gmail.com
Sponsor or person
Institute
Hyogo Prefectural Rehabilitation Hospital at Nishi-Harima
Institute
Department
Personal name
M K
Funding Source
Organization
KAKENHI Grant-in-Aid for Early-Career Scientists (25K20923)
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
Hyogo Prefectural Rehabilitation Hospital at Nishi-Harima
Address
1-7-1 Kouto, Shingu-cho, Tatsuno, Hyogo
Tel
+81-791-58-1050
k.maru5081@gmail.com
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
| 2026 | Year | 05 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 17 | 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
The 2-minute walk test (2MWT) shows a high correlation with the 6-minute walk test (6MWT) and has been adopted as an exercise tolerance assessment tool in the NIH Toolbox. In this study, we will measure muscle oxygen saturation of the tibialis anterior and gastrocnemius using near-infrared spectroscopy (NIRS) during the 2MWT in three groups (young healthy adults, elderly healthy adults, and Parkinson's disease patients, 30 subjects each, total 90). Physical cost index, pulmonary function (spirometry), grip strength, calf circumference, and SPPB (Short Physical Performance Battery) will also be assessed. NIRS measurement during maximal isometric ankle dorsiflexion will also be performed. The study aims to clarify the relationships among (i) endurance, (ii) muscle aerobic capacity, and (iii) respiratory function, and to establish a new method for skeletal muscle assessment.
Management information
Registered date
| 2026 | Year | 05 | Month | 17 | Day |
Last modified on
| 2026 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070484
