UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052010 |
|---|---|
| Receipt number | R000059257 |
| Scientific Title | A Single-Center Prospective Study of the Utility and Safety of the 1-Minute Sit-to-Stand Test Compared to the 6-Minute Walk Test in Patients with Pulmonary Hypertension |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/02/28 09:40:55 |
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Basic information
Public title
Can the 1-minute sit-to-stand test substitute for the 6-minute walk test in patients with pulmonary hypertension?
Acronym
Can the 1-minute sit-to-stand test substitute for the 6-minute walk test in patients with pulmonary hypertension?
Scientific Title
A Single-Center Prospective Study of the Utility and Safety of the 1-Minute Sit-to-Stand Test Compared to the 6-Minute Walk Test in Patients with Pulmonary Hypertension
Scientific Title:Acronym
Study of the 1-Minute Sit-to-Stand Testin Pulmonary Hypertension
Region
| Japan |
Condition
Condition
Pulmonary hypertension
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The results of the 1-minute sit-to-stand test (1STST) and 6-minute walk test (6MWT) will correlate in pulmonary hypertension, and the patient burden expected to be smaller and better tolerated with the 1STST, as reported in chronic obstructive pulmonary disease, interstitial lung disease, and chronic heart failure.In addition, the results of the 6MWT have been used universally to predict prognosis in pulmonary hypertension, and it is expected that the results of the 1STST will be similarly applicable.The purpose of this study is to establish a safer and less patient-intensive testing method in patients with pulmonary hypertension by demonstrating (1) correlation between 6MWT and 1STST results, (2) reduction of adverse events and patient burden, and (3) association between 1STST and prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the number of times standing up in 1STST and walking distance in 6MWT.
Key secondary outcomes
Correlation of results obtained in 1STST with other clinical information. Safety comparison of 1STST and 6MWT.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Perform a 1-minute sit-to-stand testand quadriceps muscle strength assessment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a diagnosis of pulmonary hypertension.
Key exclusion criteria
1) Patients with a history of orthostatic hypotension.
2) Patients with osteoarticular or neuromuscular diseases that have an effect on standing or walking.
3) Patients with inadequately controlled heart failure, cardiac disease, or arrhythmia.
4) Patients with mental illness or dementia that prevents them from performing the examination safely and accurately.
5) Patients who meet any of the following criteria
5-1. pulse rate 40/min or less, or 120/min or more at rest
5-2. systolic blood pressure 70 mmHg or less, or 200 mmHg or more at rest
5-3. diastolic blood pressure 120 mmHg or more at rest
5-4. having palpitations, shortness of breath, or chest pain at rest
5-5. having dizziness, cold sweat, or nausea in a sitting position at rest
5-6. SpO2 90% or less at rest
6) patients who are judged to be ineligible by the physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Takeda |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Chiba
TEL
+81-43-222-7171
k.takeda@chiba-u.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Takeda |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Chiba
TEL
+81-43-222-7171
Homepage URL
k.takeda@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
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
Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba, Chiba
Tel
+81-43-222-7171
k.takeda@chiba-u.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
| 2023 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 08 | Month | 25 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059257
