UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053327 |
|---|---|
| Receipt number | R000060835 |
| Scientific Title | Effects of aerobic exercise under lower extremity blood flow restriction on exercise tolerance and its mechanism elucidation |
| Date of disclosure of the study information | 2024/01/11 |
| Last modified on | 2025/04/22 16:06:20 |
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Basic information
Public title
Effects and Mechanisms of Aerobic Exercise under Lower Extremity Blood Flow Restriction on Physical Fitness.
Acronym
Effects and mechanisms of aerobic exercise under blood flow restriction on physical fitness.
Scientific Title
Effects of aerobic exercise under lower extremity blood flow restriction on exercise tolerance and its mechanism elucidation
Scientific Title:Acronym
Effects of aerobic exercise under blood flow restriction on exercise tolerance and its mechanism elucidation.
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of aerobic exercise under lower limb blood flow restriction on exercise tolerance and its mechanism.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise tolerance before and 4 weeks after intervention.
Key secondary outcomes
Oxygen extraction capacity of skeletal muscle before and 4 weeks after intervention.
Microvascular function of skeletal muscle before and 4 weeks after intervention.
Oxidative stress and antioxidant indices before and 4 weeks after intervention.
Muscle mass and strength before and 4 weeks after intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Interval exercise at 40% peak VO2 intensity for 20 minutes x 3 times a week for 4 weeks.
Interventions/Control_2
Interval exercise at an intensity of 40% peak VO2 for 20 minutes x 3 times a week for 6 weeks under restricted blood flow in both lower extremities.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria are adults between the ages of 18 and 30.
Key exclusion criteria
Current smoking habit.
Currently taking medication or dietary supplements.
Have a history of cardiovascular or metabolic disease.
Have regular physical activity.
Other cases in which the principal investigator determines that the subject is inappropriate as a research subject.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Tamiya |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252574723
tamiya@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Tamiya |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252574723
Homepage URL
tamiya@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Ethics Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
0252574455
rinri@nuhw.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 | 01 | Month | 11 | 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
| 2024 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, a preliminary experiment was conducted to examine the immediate effect of aerobic exercise under lower limb blood flow restriction on muscle oxygen extraction.
The preliminary experiment was also approved by the Ethics Review Committee.
The study design and protocol of the preliminary experiment are shown below.
Design
Randomized crossover design
Subjects
Twelve healthy adults subjects with identical inclusion and exclusion criteria.
Inclusion criteria
Aged 18 years or older, 30 years or younger, and no current smoking history.
Exclusion criteria
History of cardio-metabolic or metabolic disease, medications or supplements, regular exercise habits, and other conditions deemed inappropriate by the principal investigator.
Experimental conditions
Condition 1, 20 minutes of aerobic exercise at 40% peak VO2 intensity
Condition 2, 20 minutes of aerobic exercise at 40% peak VO2 intensity under lower extremity blood flow restriction
Primary outcome
Muscle oxygen extraction before and after intervention
Secondary outcomes
blood pressure, heart rate, and lactate before and after
Management information
Registered date
| 2024 | Year | 01 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060835
