UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041371 |
|---|---|
| Receipt number | R000047044 |
| Scientific Title | Impact of peripheral circulation and skeletal muscle function on exercise tolerance in pulmonary hypertension : Cross-sectional study analysis using infrared thermography |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2023/08/17 19:24:10 |
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Basic information
Public title
Impact of peripheral circulation and skeletal muscle function on exercise tolerance in pulmonary hypertension : Cross-sectional study analysis using infrared thermography
Acronym
Exercise tolerance in pulmonary hypertension
Scientific Title
Impact of peripheral circulation and skeletal muscle function on exercise tolerance in pulmonary hypertension : Cross-sectional study analysis using infrared thermography
Scientific Title:Acronym
Impact of peripheral circulation on exercise tolerance in pulmonary hypertension
Region
| Japan |
Condition
Condition
pulmonary hypertension, cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine impact of peripheral circulation before and after exercise in patients with pulmonary hypertension
Basic objectives2
Others
Basic objectives -Others
The association between peripheral circulation and exercise tolerance
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the association between the change of body surface temperature and 6 minites walk distance
Key secondary outcomes
skeletal muscle thickness, hemodynamics
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
pulmonary hypertension, cardiovascular disease
Key exclusion criteria
unavailable of written informed consent,
judged to be inappropriate by physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakayama |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8654
Address
7-3-1, Hongo, Bukyo-ku, Tokyo, Japan
TEL
0338155411
st7089-fki@umin.ac.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Shimbo |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8654
Address
7-3-1, Hongo, Bukyo-ku, Tokyo, Japan
TEL
0338155411
Homepage URL
shimbom-int@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese Association of Cardiac Rehabilitation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University
Address
7-3-1, Hongo, Bukyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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 | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 08 | 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
| 2020 | Year | 08 | Month | 10 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047044
