UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055290 |
|---|---|
| Receipt number | R000063177 |
| Scientific Title | Outpatient cardiac rehabilitation effects |
| Date of disclosure of the study information | 2024/08/21 |
| Last modified on | 2024/08/20 18:03:26 |
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Basic information
Public title
A comparative study of the effectiveness of outpatient cardiac rehabilitation in clinics and hospitals for patients with cardiovascular disease
Acronym
Outpatient cardiac rehabilitation effects
Scientific Title
Outpatient cardiac rehabilitation effects
Scientific Title:Acronym
Outpatient cardiac rehabilitation effects
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct a pilot study to compare the effectiveness of cardiac rehabilitation at a hospital with adequate facilities and staff and at a clinic, in order to explore the creation of a system that can simplify outpatient cardiac rehabilitation at a clinic.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of anaerobic threshold before and 5 months after starting outpatient cardiac rehabilitation
Key secondary outcomes
Comparison of right grip strength, left grip strength, average grip strength, right lower limb muscle strength, left lower limb muscle strength, average lower limb muscle strength, WBI, right single leg standing time, left single leg standing time, 10m walking time, 10m walking steps, 10m walking step length, 10m walking speed, stand-up test, 2-step test, stair climbing test, SPPB test, right thigh circumference, left thigh circumference, 2-minute walking distance, TUG, food intake frequency survey, PHQ-9, HADS, locomotive syndrome level, SF-36, frailty check, blood and urine test findings, chest X-ray, echocardiogram, ABI, spirogram, and exercise tolerance before and 5 months after starting outpatient cardiac rehabilitation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Cardiac rehabilitation is carried out in hospitals.
Interventions/Control_2
Cardiac rehabilitation is performed in clinic.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cardiovascular disease who are eligible for outpatient cardiac rehabilitation at the Department of Cardiology at Fukuoka University Hospital and Miyase Internal Medicine Clinic. The male:female ratio must be matched.
Key exclusion criteria
If the patient's cardiovascular condition is unstable, or if medical doctor determines that cardiac rehabilitation is inappropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shin-ichiro |
| Middle name | |
| Last name | Miura |
Organization
Fukuoka University
Division name
Department of Cardiology
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL
092-801-1011
miuras@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Department of Bioethics & Medical Ethics |
| Middle name | |
| Last name | Fukuoka University |
Organization
Fukuoka University
Division name
Ethics Review Board
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL
092-801-1011
Homepage URL
fumed-ethics@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
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
Fukuoka University
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
Tel
092-801-1011
fumed-ethics@fukuoka-u.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
| 2024 | Year | 08 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 09 | 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
| 2024 | Year | 08 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063177
