UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061225 |
|---|---|
| Receipt number | R000070063 |
| Scientific Title | Effects of Mask-Based Intermittent Hypoxic Training on Improvement of Exercise Tolerance |
| Date of disclosure of the study information | 2026/04/10 |
| Last modified on | 2026/04/10 15:08:34 |
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Basic information
Public title
Effects of Mask-Based Intermittent Hypoxic Training on Improvement of Exercise Tolerance
Acronym
Effects of Mask-Based Intermittent Hypoxic Training on Improvement of Exercise Tolerance
Scientific Title
Effects of Mask-Based Intermittent Hypoxic Training on Improvement of Exercise Tolerance
Scientific Title:Acronym
Effects of Mask-Based Intermittent Hypoxic Training on Improvement of Exercise Tolerance
Region
| Japan |
Condition
Condition
Study 1: Healthy adults (18 to 30 years)
Study 2: Healthy older adults (65 years and above)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As a fundamental study aimed at improving exercise tolerance in older patients with chronic diseases, this study investigates the effects of mask-based hypoxic training on exercise tolerance in healthy adults and healthy older individuals.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
peak oxygen uptake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Intermittent hypoxic training
Interventions/Control_2
Intermittent hypoxic training plus electrical muscle stimulation
Interventions/Control_3
Intermittent hypoxic training plus aerobic exercise
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Study 1: Healthy adults aged 18 to 30 years (undergraduate or graduate students)
Study 2: Healthy older adults aged 65 years and above
Key exclusion criteria
1. Smokers
2. Individuals receiving pharmacological treatment for anemia
3. Individuals belonging to athletic clubs or engaging in regular training
4. Individuals with implanted devices such as pacemakers
5. Individuals for whom cardiopulmonary exercise testing is difficult due to orthopedic, respiratory, or cardiovascular diseases
6. Individuals who have undergone joint replacement surgery
7. Individuals at risk of exacerbation of underlying diseases (e.g., orthopedic, respiratory, cardiovascular diseases, diabetes) due to exercise therapy
8. Individuals who have required hospitalization for any underlying disease within the past 6 months
9. Individuals who are regularly receiving medical care for underlying diseases must have permission from their attending physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Saitoh |
| Middle name | |
| Last name | Masakazu |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
1130033
Address
Hongo, Ochanomizu, Bunkyo, Tokyo
TEL
03-3813-3111
m.saito.tl@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Saitoh |
| Middle name | |
| Last name | Masakazu |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
1130033
Address
Hongo, Ochanomizu, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
t.kobayashi.ns@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Faculty of Health Sciences Research Ethics Committee
Address
Hongo, Ochanomizu, Bunkyo-ku, Tokyo
Tel
03-3813-3111
t.kobayashi.ns@juntendo.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
| 2026 | Year | 04 | Month | 10 | 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 | 10 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 04 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070063
