UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062295 |
|---|---|
| Receipt number | R000071290 |
| Scientific Title | Elucidating gait changes associated with exertional hypoxemia in chronic respiratory disease and identifying fall risk indicators applicable to home medical care |
| Date of disclosure of the study information | 2026/07/21 |
| Last modified on | 2026/07/21 23:16:52 |
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Basic information
Public title
Elucidating temporal changes in percutaneous arterial oxygen saturation and gait during dyspnea, and exploring fall risk
Acronym
Exploratory study of SpO2 desaturation, gait changes, and fall risk during dyspnea
Scientific Title
Elucidating gait changes associated with exertional hypoxemia in chronic respiratory disease and identifying fall risk indicators applicable to home medical care
Scientific Title:Acronym
Gait-EH Study
Region
| Japan |
Condition
Condition
Chronic respiratory disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To simultaneously measure SpO2 time-series and gait metric time-series during the 6-Minute Walk Test (6MWT), quantify the effect of SpO2 decline on gait changes, and identify the SpO2 threshold that predicts gait deterioration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Nadir SpO2 during the 6-Minute Walk Test (6MWT), and the presence or absence of gait breakdown (defined as stride length coefficient of variation [CoV] > healthy reference mean + 1.5 SD). The association between the two will be evaluated using ROC analysis.
Key secondary outcomes
1. Stride length coefficient of variation (CoV) during the 6-Minute Walk Test (6MWT): comparison between the EH and non-EH groups. 2. Temporal correspondence between the onset of SpO2 decline and the gait change point during the 6MWT. 3. Physical function (Short Physical Performance Battery, SPPB) and psychological status (Falls Efficacy Scale-International, FES-I): comparison between the EH and non-EH groups.
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Disease: Stable chronic respiratory disease (primarily COPD and interstitial lung disease) / Age: 40 years or older / Pulmonary function: Obstructive or restrictive ventilatory impairment confirmed by spirometry / Ambulatory status: Able to walk independently (with or without a walking aid) / Physical condition: Able to perform the 6MWT / Capacity to consent: Able to provide written informed consent
Key exclusion criteria
1. Acute exacerbation: History of acute exacerbation (e.g., airway infection, worsening dyspnea) or hospitalization within 1 month before enrollment. 2. Long-term oxygen therapy (LTOT): Patients for whom adequate oxygenation during the 6MWT cannot be maintained without changing the usual conditions (flow rate, device). 3. Neurological, muscular, or musculoskeletal disease: Any condition affecting gait (e.g., Parkinson's disease, post-stroke sequelae, peripheral neuropathy, osteoarthritis, post-fracture sequelae). 4. Cognitive function: Unable to provide consent due to cognitive impairment. 5. Physician's judgment: Deemed ineligible for participation by the attending physician for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Suyama |
Organization
Reiwa Health Sciences University
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
811-0213
Address
2-1-12 Wajirogaoka, Higashi-ku, Fukuoka
TEL
+81926076701
kazuaki.suyama@rhs-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Suyama |
Organization
Reiwa Health Sciences University
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
811-0213
Address
2-1-12 Wajirogaoka, Higashi-ku, Fukuoka
TEL
+81926076701
Homepage URL
kazuaki.suyama@rhs-u.ac.jp
Sponsor or person
Institute
Reiwa Health Sciences University
Institute
Department
Personal name
Kazuaki Suyama
Funding Source
Organization
Yuumi Memorial Foundation for Home Health Care
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tagami Hospital, Utsunomiya Medical Clinic, Kyusyu University Hospital, Nagasaki University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Reiwa Health Sciences University
Address
2-1-12 Wajirogaoka, Higashi-ku, Fukuoka
Tel
+81926076701
krinri@rhs-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
田上病院、宇都宮内科医院、九州大学病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 21 | 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
| 2026 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | 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
This study is a cross-sectional observational study; no intervention is performed on participants. In 40 patients with stable chronic respiratory disease, percutaneous arterial oxygen saturation (SpO2) and gait metrics are continuously and simultaneously measured during the 6-Minute Walk Test (6MWT) using a pulse oximeter and bilateral foot-worn sensors (ORPHE ANALYTICS MEDICAL). The two time-series datasets are analyzed to compare gait metrics according to the presence or absence of exertional hypoxemia (EH; nadir SpO2 < 88%), and to examine the temporal correspondence between SpO2 decline and gait changes using ROC analysis and changepoint detection. Participants are recruited from three institutions (Tagami Hospital, Utsunomiya Medical Clinic, Kyushu University Hospital).
Management information
Registered date
| 2026 | Year | 07 | Month | 21 | Day |
Last modified on
| 2026 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071290
