UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049736 |
|---|---|
| Receipt number | R000056619 |
| Scientific Title | Association of Home Exercise Goal Attainment and Improvement in Exercise Tolerance by Single Exercise Prescription for Chronic Heart Failure Patients |
| Date of disclosure of the study information | 2022/12/09 |
| Last modified on | 2026/06/15 15:11:27 |
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Basic information
Public title
Association of Home Exercise Goal Attainment and Improvement in Exercise Tolerance by Single Exercise Prescription for Chronic Heart Failure Patients
Acronym
Association of Home Exercise Goal Attainment and Improvement in Exercise Tolerance by Single Exercise Prescription for Chronic Heart Failure Patients
Scientific Title
Association of Home Exercise Goal Attainment and Improvement in Exercise Tolerance by Single Exercise Prescription for Chronic Heart Failure Patients
Scientific Title:Acronym
Association of Home Exercise Goal Attainment and Improvement in Exercise Tolerance by Single Exercise Prescription for Chronic Heart Failure Patients
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between home exercise achievement and improvement of exercise tolerance by a single exercise prescription in patients with chronic heart failure
Basic objectives2
Others
Basic objectives -Others
We will conduct home rehabilitation for 3 months and examine the effects on the rehabilitation achievement rate and exercise tolerance in a single exercise prescription (i.e., rehabilitation instruction is given once at the beginning of the study, but thereafter no active intervention related to rehabilitation is provided until the end of rehabilitation).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximal oxygen uptake (Peak VO2) during cardiopulmonary stress test (CPX)
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
The patient will be fitted with a triaxial accelerometer and undergo rehabilitation at home for 3 months
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are eligible
Patients with a history of hospitalization for acute or chronic heart failure
Patients who are at least 20 years of age
Patients who can undergo cardiopulmonary excise test (CPX).
Patients in stable general condition who can be rehabilitated under unsupervised conditions.
Key exclusion criteria
Patients who are determined to be in conflict with any of the following criteria will be excluded from the study.
Patients who have or are scheduled to have a pacemaker, ICD, CRT(D), or other medical device
Patients scheduled for PCI, CABG, or other cardiac surgery
Patients with a limited prognosis due to irreversible factors such as malignancy
Patients with obvious cognitive dysfunction
Patients on maintenance dialysis
Patients who are judged to have difficulty with CPX or home rehabilitation due to limb impairment, degree of cardiac insufficiency, etc
Patients who cannot give written consent
Patients deemed inappropriate for this study by the physician in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Yamaguchi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Cardiology, Pulmonology, Hypertension and Nephrology
Zip code
791-0295
Address
454, Shitsukawa, Toon city, Ehime, JAPAN
TEL
0899605303
yamaguti@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigehiro |
| Middle name | |
| Last name | Miyazaki |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Cardiology, Pulmonology, Hypertension and Nephrology
Zip code
791-0295
Address
454, Shitsukawa, Toon city, Ehime, JAPAN
TEL
0899605303
Homepage URL
miyazaki.shigehiro.lw@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-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
愛媛大学医学部付属病院（愛媛県）、喜多医師会病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
The study protocol has not been made publicly available
Publication of results
Unpublished
Result
URL related to results and publications
No publication URL is available because the results have not been published
Number of participants that the trial has enrolled
5
Results
Patient enrollment and final follow-up have been completed. However, data lock and statistical analyses have not yet been completed, and the results for the primary and secondary outcomes have not been published. The results will be updated promptly after completion of the analyses.
Results date posted
| 2026 | Year | 06 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 5 participants were enrolled, and final follow-up has been completed. However, data lock and aggregation of baseline characteristics have not yet been completed; therefore, details such as age, sex, underlying diseases, and CPX-related parameters have not yet been summarized. These data will be updated after completion of the analysis.
Participant flow
A total of 5 participants were enrolled. Assessment of physical activity using an activity monitor, rehabilitation intervention, and cardiopulmonary exercise testing (CPX) were performed, and final follow-up has been completed. However, data lock has not yet been completed, and the final numbers of participants who completed the intervention, underwent CPX, withdrew, or were included in the analysis have not yet been confirmed. Participant flow will be updated after data lock.
Adverse events
In this study, a rehabilitation intervention including assessment of physical activity using an activity monitor and cardiopulmonary exercise testing (CPX) was conducted. To date, no serious adverse events clearly related to the study intervention or CPX have been identified. However, the final summary of adverse events has not yet been completed and will be updated after data lock and completion of the analysis.
Outcome measures
The primary outcome measure was the change in peak oxygen uptake (peak VO2) assessed by cardiopulmonary exercise testing (CPX).
Secondary outcome measures included changes in CPX parameters other than peak VO2, including VO2, anaerobic threshold (AT), respiratory compensation point (RCP), VCO2, PETCO2, tidal volume, respiratory rate, minute ventilation, inspiratory time, total respiratory time, respiratory exchange ratio, work rate, blood pressure, heart rate, and SpO2; changes in cardiac structural and functional parameters assessed by exercise stress echocardiography, including left ventricular, right ventricular, and left atrial dimensions and volumes, left ventricular ejection fraction, transmitral flow parameters, mitral annular early diastolic velocity, peak tricuspid regurgitation velocity, mitral regurgitation, and tricuspid regurgitation, changes in body composition parameters assessed by InBody, including body weight, muscle mass, total body water, protein mass, mineral mass, body fat mass, body fat percentage, and BMI, changes in blood biomarkers, including BNP and NT-proBNP, changes in Frailty Scale, QOL score assessed by EQ-5D-5L, and cognitive function assessed by MMSE, rehabilitation achievement rate; and questionnaire survey results.
Data lock and statistical analyses have not yet been completed, and the results for each outcome measure have not been published. These results will be updated after completion of the analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 09 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056619
