UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055280 |
|---|---|
| Receipt number | R000045367 |
| Scientific Title | Exploratory study on changes in respiratory and metabolic functions using aerobic exercise (cycle ergometer) and Neuromuscular electrical stimulation in healthy subjects (including athletes) |
| Date of disclosure of the study information | 2024/08/31 |
| Last modified on | 2024/08/19 19:36:46 |
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Basic information
Public title
Exploratory study on changes in respiratory and metabolic functions using aerobic exercise (cycle ergometer) and Neuromuscular electrical stimulation in healthy subjects (including athletes)
Acronym
Exploratory study on changes in respiratory and metabolic functions using aerobic exercise (cycle ergometer) and Neuromuscular electrical stimulation in healthy subjects (including athletes)
Scientific Title
Exploratory study on changes in respiratory and metabolic functions using aerobic exercise (cycle ergometer) and Neuromuscular electrical stimulation in healthy subjects (including athletes)
Scientific Title:Acronym
Exploratory study on changes in respiratory and metabolic functions using aerobic exercise (cycle ergometer) and Neuromuscular electrical stimulation in healthy subjects (including athletes)
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate myokine between exercise style
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
myokine
Key secondary outcomes
immune
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
electrical stimulation
Interventions/Control_2
no electrical stimulation
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy adults
Key exclusion criteria
patients with severe heart failure, renal failure, stroke, other malignant desease.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Sugimoto |
Organization
Kurume University
Division name
Division of Rehabilitation
Zip code
8300011
Address
Kurume-shi
TEL
0942317568
sugimoto_takahiro@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | RYUKI |
| Middle name | |
| Last name | Hashida |
Organization
Kurume University Hospital
Division name
Division of Rehabilitation
Zip code
8300011
Address
67 Asahimachi, Kurume-shi
TEL
0942317568
Homepage URL
hashida_ryuuki@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
none
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
Kurume university
Address
67 Asahi-machi, Kurume-shi
Tel
0942317568
hashida_ryuuki@med.kurume-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 31 | 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
16
Results
Obesity was a significantly independent factor for the delta of BDNF. The delta BDNF in the electrical stimulation group was significantly higher than in the control group in obese subjects whose BMI was greater than 25.
Results date posted
| 2024 | Year | 08 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adult man
Participant flow
Adverse events
None
Outcome measures
brain-derived neurotrophic factor
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 08 | Month | 19 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 19 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045367
