UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040153 |
|---|---|
| Receipt number | R000045774 |
| Scientific Title | Autonomic nervous activity during exercise in intellectually disabled people. |
| Date of disclosure of the study information | 2020/04/14 |
| Last modified on | 2023/04/17 10:37:48 |
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Basic information
Public title
Autonomic nervous activity during exercise in intellectually disabled people.
Acronym
Autonomic nervous activity during exercise in intellectually disabled people.
Scientific Title
Autonomic nervous activity during exercise in intellectually disabled people.
Scientific Title:Acronym
Autonomic nervous activity during exercise in intellectually disabled people.
Region
| Japan |
Condition
Condition
Intellectually disabled people.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of moderate exercise and post exercise deep breathing on autonomic nervous activity in intellectually disabled people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability analysis during exercise and recovery.
Key secondary outcomes
Blood pressure; Percutaneous oxygen saturation during recovery.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Incremental exercise on bicycle ergometer (Intensity: 40-60% HRmax; Duration: 8 minutes) without deep breathing during recovery.
Washout(1 month)
Incremental exercise on bicycle ergometer (Intensity: 40-60% HRmax; Duration: 8 minutes) with deep breathing during recovery.
Interventions/Control_2
Incremental exercise on bicycle ergometer (Intensity: 40-60% HRmax; Duration: 8 minutes) with deep breathing during recovery.
Washout(1 month)
Incremental exercise on bicycle ergometer (Intensity: 40-60% HRmax; Duration: 8 minutes) without deep breathing during recovery.
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
Mentally disabled or healthy people.
Key exclusion criteria
Restriction of physical activity.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Chigaya |
| Middle name | |
| Last name | Tadano |
Organization
Toho university
Division name
School of medicine
Zip code
1438540
Address
5-21-16 Ohmori-nishi Ota-ku Tokyo Japan
TEL
03-3762-4151
chy-td@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Chigaya |
| Middle name | |
| Last name | Tadano |
Organization
Toho university
Division name
School of medicine
Zip code
1438540
Address
5-21-16 Ohmori-nishi Ota-ku Tokyo Japan
TEL
03-3762-4151
Homepage URL
chy-td@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japan health promotion and fitness foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Toho University school of medicine
Address
5-21-16 Ohmori-nishi Ohta-ku Tokyo Japan
Tel
03-3762-4151ext2455
med.rinri@ext.toho-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
| 2020 | Year | 04 | Month | 14 | 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
40
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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045774
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
