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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000027894
Receipt No. 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

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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
Email 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
Email ydohi@ngu.ac.jp

Sponsor
Institute Faculty of Rehabilitation Science
Nagoya Gakuin University
Institute
Department

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
Email

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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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