UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046514 |
|---|---|
| Receipt number | R000053067 |
| Scientific Title | Effect of Exertional Dyspnea on the Mobilization Program in Patients with Heart Failure |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2021/12/31 01:25:15 |
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Basic information
Public title
Effect of Exertional Dyspnea on the Mobilization Program in Patients with Heart Failure
Acronym
Effect of Exertional Dyspnea on the Mobilization Program in Patients with Heart Failure
Scientific Title
Effect of Exertional Dyspnea on the Mobilization Program in Patients with Heart Failure
Scientific Title:Acronym
Effect of Exertional Dyspnea on the Mobilization Program in Patients with Heart Failure
Region
| Japan |
Condition
Condition
acute decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the relationship between dyspnea on exertion and the early mobilization program to predict delayed mobilization. We hypothesized that the dyspnea on exertion in the early hospitalization phase could predict a delay in the early mobilization program.
Basic objectives2
Others
Basic objectives -Others
Investigation of predictors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the length of the mobilization program
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We included all consecutive patients who were hemodynamically stabilized after introducing intravenous medication for acute HF and who were able to walk more than 10 m before admission in Shizuoka City Shimizu Hospital.
Key exclusion criteria
We excluded patients who were unable to undergo testing due to cognitive impairment, who died during hospitalization, or who could not obtain consent to participate in the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yota |
| Middle name | |
| Last name | Yamazaki |
Organization
Shizuoka City Shimizu Hospital
Division name
Department of Rehabilitation Technology
Zip code
424-8636
Address
1231 Miyakami, Shimizu-Ku, Shizuoka, Shizuoka, Japan
TEL
0543361111
11rp31@g.seirei.ac.jp
Public contact
Name of contact person
| 1st name | Yota |
| Middle name | |
| Last name | Yamazaki |
Organization
Shizuoka City Shimizu Hospital
Division name
Department of Rehabilitation Technology
Zip code
424-8636
Address
1231 Miyakami, Shimizu-Ku, Shizuoka, Shizuoka, Japan
TEL
0543361111
Homepage URL
11rp31@g.seirei.ac.jp
Sponsor or person
Institute
Shizuoka City Shimizu Hospital Ethics Review Committee
Institute
Department
Personal name
Funding Source
Organization
Shizuoka City Shimizu Hospital
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
Shizuoka City Shimizu Hospital Ethics Review Committee
Address
1231 Miyakami, Shimizu-Ku, Shizuoka, Shizuoka, Japan
Tel
0543361111
smz-hsp-soumu@city.shizuoka.lg.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
| 2021 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
52
Results
The length of the mobilization program was significantly correlated with the start of the mobilization program (r = .41) and VAS on day 3 (r = .60) (P < .05). In multiple regression analyses, the length of the mobilization program showed a significant relationship with VAS measurement on day 3 or the length until the start of the mobilization program (P < .05). The standardized coefficients for VAS on day 3 and the length until the start of the mobilization program were .49 and .33, respectively.
Results date posted
| 2021 | Year | 12 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The New York Heart Association class was Class II 4 (8%), III 25 (48%), and IV 23 (44%). The etiology of HF was ischemic heart disease in 11 patients (22%), valvular heart disease in 11 patients (22%), hypertension in 11 patients (22%), and dilated cardiomyopathy in 4 patients (8%). Medical history included hypertension in 36 patients (69%), diabetes in 13 patients (25%), chronic kidney disease in 9 patients (18%), chronic obstructive pulmonary disease in 8 patients (16%), and atrial fibrillation in 19 patients (36%).
Participant flow
Fifty-four patients, excluding 8 who were unable to be tested and measured due to cognitive decline at the time of admission, participated in the study. Two patients dropped out after hospitalization due to death, and there were 52 patients in the study.
Adverse events
None
Outcome measures
The length of the mobilization program
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Dyspnea on exertion was assessed using the visual analog scale within a mobilization program implemented after the improvement of acute decompensated heart failure.
Management information
Registered date
| 2021 | Year | 12 | Month | 31 | Day |
Last modified on
| 2021 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053067
