UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027894 |
|---|---|
| Receipt number | R000031958 |
| Scientific Title | Effects of physical therapy on blood pressure |
| Date of disclosure of the study information | 2017/06/23 |
| Last modified on | 2020/12/25 09:18:23 |
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Basic information
Public title
Effects of physical therapy on blood pressure
Acronym
PTBP
Scientific Title
Effects of physical therapy on blood pressure
Scientific Title:Acronym
PTBP
Region
| Japan |
Condition
Condition
Stroke, joint operation, bone fracture operation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigaate changes in systolic or diastolic blood pressure after physical therapy
Basic objectives2
Others
Basic objectives -Others
Blood pressure usually respond to various physical stimuli, resulting in a transient increase or decrease in blood pressure. Although physical therapy can affect blood pressure, changes in systolic or diastolic blood pressure after physical therapy have not been intensively studied and, thus, the amplitude of abnormal as well as standard responses of blood pressure to physical therapy are not understood. The present study is conducted to investigate how physical therapy affect blood pressure.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood pressure and heart rate from the baseline level to 0, 2, and 5 mimutes after physical therapy
Key secondary outcomes
(1) Effects of continuing physical therapy on responses of blood pressure and heart rate to physical therapy
(2) Factors affecting changes in blood pressure and heart rate after physical therapy
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Inpatients with stroke attack and those who have a joint operation or an operation for bone fracture in our hospitals, or
(2) Outpatients with stroke or those who had a joint operation or an operation for bone fracture undergoing physical therapy
Key exclusion criteria
Subjects whose blood pressure cannot be accurately measured due to arrhythmia
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YASUAKI DOHI |
Organization
Nagoya Gakuin University
Division name
Faculty of Rehabilitation Science
Zip code
Address
1350 Kamishinano-cho, Seto 480-1298, Japan
TEL
0561-42-0350
ydohi@ngu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YASUAKI DOHI |
Organization
Nagoya Gakuin University
Division name
Faculty of Rehabilitation Science
Zip code
Address
1350 Kamishinano-cho, Seto 480-1298, Japan
TEL
0561-42-0350
Homepage URL
ydohi@ngu.ac.jp
Sponsor or person
Institute
Faculty of Rehabilitation Science
Nagoya Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Nagoya Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fujieda Heisei Memorial Hospital
Nagoya City West Medical Center
Akaiwa Hospital
Municipal Ena Hospital
Kashiwazaki General Hospital and Medical Center
Mukoyama Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 06 | Month | 23 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study and there is no intervention. The following endpoints will be analyzed.
(1) Changes in blood pressure and heart rate from the baseline level to 0, 2, and 5 mimutes after physical therapy
(2) Effects of continuing physical therapy on responses of blood pressure and heart rate to physical therapy
(3) Factors affecting changes in blood pressure and heart rate after physical therapy
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2020 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031958
| 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 |
