UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048879 |
|---|---|
| Receipt number | R000055699 |
| Scientific Title | Effect of supine exercise on heart rate variability during head-up tilt testing in healthy adults |
| Date of disclosure of the study information | 2022/09/15 |
| Last modified on | 2025/09/09 09:11:50 |
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Basic information
Public title
Effect of supine exercise on autonomic nerve activity during head-up tilt testing in healthy adults
Acronym
Effect of supine exercise on autonomic nerve activity during head-up tilt testing in healthy adults
Scientific Title
Effect of supine exercise on heart rate variability during head-up tilt testing in healthy adults
Scientific Title:Acronym
Effect of supine exercise on heart rate variability during head-up tilt testing in healthy adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Cardiology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effect of arm or leg exercise performed in the supine position on heart rate variability during head-up tilt testing in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability during 5-min 70 degrees head-up tilt
Key secondary outcomes
Blood pressure, heart rate, and subjective symptoms during 5-min 70 degrees head-up tilt
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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants rest in the supine position during a 1-min intervention period.
Interventions/Control_2
Upper extremity exercise condition: In the supine position, participants perform 30 repetitive 90 degrees of both shoulders flexion while holding the elbow in extension during a 1-min intervention period.
Interventions/Control_3
Lower extremity exercise condition: In the supine position, participants perform 30 repetitive hip flexion as much as possible while holding the knee in extension alternatively left and right during a 1-min intervention period.
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age between 18 and 40 years old
2. Not a habitual smoker
3. Able to understand the study and give consent
Key exclusion criteria
1. Limited range of motion and/or pain that can affect a head-up tilt test and exercise tasks with upper or lower extremities
2. Severe orthostatic hypotension that can affect a head-up tilt test
3. Trauma to the upper arm that prevents the participant from wearing a blood pressure cuff
4. Cardiac or peripheral circulatory diseases
5. Neurological disorders
6. Use of autonomic drugs, such as antihypertensive medications and bronchodilators
7. Receiving metal implant treatment
8. Individuals deemed inappropriate by the principal investigator
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Oyake |
Organization
Shinshu University
Division name
Department of Physical Therapy
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2413
k_oyake@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Oyake |
Organization
Shinshu University
Division name
Department of Physical Therapy
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2413
Homepage URL
k_oyake@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
A grant from the Funds for Grant-in-Aid for Young Scientist
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Shinshu University
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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
信州大学（長野県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
32
Results
There was no significant effect of pre-standing exercise on orthostatic changes in heart rate variability. However, a smaller orthostatic decrease in systolic blood pressure and a greater orthostatic increase in diastolic blood pressure were observed in the pre-standing exercise condition. Therefore, pre-standing lower limb exercise may prevent the decrease in systolic blood pressure by enhancing sympathetic nervous activity toward peripheral blood vessels.
Results date posted
| 2025 | Year | 09 | Month | 09 | Day |
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 09 | Month | 07 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055699
