UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054280 |
|---|---|
| Receipt number | R000061986 |
| Scientific Title | Muscle pump-induced respiratory and cardiovascular regulations |
| Date of disclosure of the study information | 2024/04/29 |
| Last modified on | 2024/04/29 10:46:25 |
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Basic information
Public title
Muscle pump-induced respiratory and cardiovascular regulations
Acronym
Respiratory and cardiovascular regulations via muscle pump during exercise
Scientific Title
Muscle pump-induced respiratory and cardiovascular regulations
Scientific Title:Acronym
Respiratory and cardiovascular regulations via muscle pump during exercise
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to elucidate the muscle pump-induced respiratory and cardiovascular regulations during exercise
Basic objectives2
Others
Basic objectives -Others
The purpose of the present study is to elucidate the muscle pump-induced respiratory and cardiovascular regulations during exercise
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Venous blood flow, heart rate, arterial blood pressure, muscle sympathetic nerve activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Isometric knee extension exercise: 10%MVC 2 sec on, 2 sec off. Respiration: 2 sec inspiration, 2 sec expiration.
Day 1: Explanation of the experiment. Day 2: Measurement of respiratory and cardiovascular parameters
Interventions/Control_2
Dynamic knee extension-flexion exercise: 10%MVC 2 sec on, 2 sec off. Respiration: 2 sec inspiration, 2 sec expiration.
Day 1: Explanation of the experiment. Day 2: Measurement of respiratory and cardiovascular parameters
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants with cardiovascular, respiratory, and orthopedics diseases
Key exclusion criteria
Patients with cardiovascular, respiratory, and orthopedics diseases
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Keisho |
| Middle name | |
| Last name | Katayama |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
Furocho, Chikusaku, Nagoya
TEL
0527895754
katayama@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisho |
| Middle name | |
| Last name | Katayama |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
Furocho, Chikusaku, Nagoya
TEL
0527895754
Homepage URL
katayama@htc.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Nagoya University
Address
Furocho, Chikusaku, Nagoya
Tel
0527893946
htc-rinri@adm.nagoya-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 | 04 | Month | 29 | 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
| 2023 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 25 | 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
Management information
Registered date
| 2024 | Year | 04 | Month | 29 | Day |
Last modified on
| 2024 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061986
