UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053371 |
|---|---|
| Receipt number | R000060888 |
| Scientific Title | Are orthostatic heart rate increases and severity of orthostatic symptoms associated with symptoms of depression and anxiety in healthy university students? |
| Date of disclosure of the study information | 2024/01/16 |
| Last modified on | 2024/07/17 09:01:53 |
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Basic information
Public title
Are orthostatic heart rate increases and severity of orthostatic symptoms associated with symptoms of depression and anxiety in healthy university students?
Acronym
Are orthostatic heart rate increases and severity of orthostatic symptoms associated with symptoms of depression and anxiety in healthy university students?
Scientific Title
Are orthostatic heart rate increases and severity of orthostatic symptoms associated with symptoms of depression and anxiety in healthy university students?
Scientific Title:Acronym
Are orthostatic heart rate increases and severity of orthostatic symptoms associated with symptoms of depression and anxiety in healthy university students?
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether an orthostatic increase in heart rate and the severity of orthostatic symptoms are associated with the symptoms of depression and anxiety in healthy university students.
Basic objectives2
Others
Basic objectives -Others
This study aims to investigate whether an orthostatic increase in heart rate and the severity of orthostatic symptoms are associated with the symptoms of depression and anxiety in healthy university students.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Hospital Anxiety and Depression Scale
Key secondary outcomes
1. Outcomes of head-up tilt test
Orthostatic changes in heart rate, heart rate variability, systolic and diastolic blood pressure, and symptoms
Heart rate, heart rate variability, systolic and diastolic blood pressure in the supine position
2. Presence of events that cause depressed mood
3. Presence of events that cause anxiety
4. Breslow's Health Practice Index
5. Presence of physical symptoms suggesting orthostatic dysregulation
6. Sex
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Absence of underlying diseases
2. Able to understand the study and give consent
Key exclusion criteria
1. Limited range of motion and/or pain that prevent them to perform a head-up tilt test
2. Pregnant or possibly pregnant
3. Diagnosed with postural orthostatic tachycardia syndrome
4. Taking any medication for depressive symptoms or anxiety
Target sample size
40
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
0263-37-2408
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
0263-37-2408
Homepage URL
k_oyake@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
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
| 2024 | Year | 01 | Month | 16 | 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 | 01 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
We examine whether an orthostatic increase in heart rate and the severity of orthostatic symptoms are associated with the symptoms of depression and anxiety in healthy university students.
Management information
Registered date
| 2024 | Year | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060888
