UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045032 |
|---|---|
| Receipt number | R000046180 |
| Scientific Title | Effects of structured mobility program to promote earlier and enhanced rehabilitation on clinical outcomes in acute heart failure patients |
| Date of disclosure of the study information | 2021/08/02 |
| Last modified on | 2023/05/07 12:13:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of structured mobility program to promote earlier and enhanced rehabilitation on clinical outcomes in acute heart failure patients
Acronym
Effects of structured mobility program to promote earlier and enhanced rehabilitation on clinical outcomes in acute heart failure patients
Scientific Title
Effects of structured mobility program to promote earlier and enhanced rehabilitation on clinical outcomes in acute heart failure patients
Scientific Title:Acronym
Effects of structured mobility program to promote earlier and enhanced rehabilitation on clinical outcomes in acute heart failure patients
Region
| Japan |
Condition
Condition
acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of structured mobility program to promote earlier and enhanced rehabilitation on physical activity in acute heart failure patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activities of daily living (ADL) on the 9th day after hospitalization
Key secondary outcomes
1) Length of hospital stay
2) Days until initiation of independent rehabilitation
3) ADL at hospital discharge
4) Ability of physical performance on the 9th day after hospitalization and at hospital discharge
5) Mental state
6) Quality of life (QOL)
7) Cardiovascular events during hospital stay and after hospital discharge for 1 year
8) Medical costs during hospital stay and after hospital discharge for 1 year
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Structured mobility program group
Interventions/Control_2
Usual care group
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Acute heart failure patients diagnosed by the Framingham criteria for congestive heart failure
Key exclusion criteria
1) A patient who could not walk alone without any support before hospitalization
2) A patient who needs to be treated with mechanical assist devices such as ventilator, IABP, and PCPS
3) A patient who has active infection such as acute pneumonia
4) A patients who has malignant disease such as cancer
5) A patient who has difficulty in following structured mobility program for some reasons such as severe cognitive impairment
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Ishikawa |
Organization
Hokkaido University of Science
Division name
Dept. of Nursing, Faculty of Health Science
Zip code
006-8585
Address
15-4-1, Maeda 7-jo, Teine-ku, Sapporo-shi, Hokkaido 006-8585, Japan
TEL
011-688-2354
ishikawa-k@hus.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Ishikawa |
Organization
Hokkaido University of Science
Division name
Dept. of Nursing, Faculty of Health Science
Zip code
006-8585
Address
15-4-1, Maeda 7-jo, Teine-ku, Sapporo-shi, Hokkaido 006-8585, Japan
TEL
011-688-2354
Homepage URL
ishikawa-k@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion Scinece
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
Hokkaido University of Science
Address
15-4-1, Maeda 7-jo, Teine-ku, Sapporo-shi, Hokkaido 006-8585, Japan
Tel
011-688-2241
kenkyu@hus.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
網走厚生病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046180
