UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038843 |
|---|---|
| Receipt number | R000044296 |
| Scientific Title | Effects of exercise intensity above anaerobic threshold on exercise tolerance in patients with heart disease |
| Date of disclosure of the study information | 2019/12/11 |
| Last modified on | 2022/12/12 15:20:11 |
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Basic information
Public title
Effects of exercise intensity above anaerobic threshold on exercise tolerance in patients with heart disease
Acronym
Effects of exercise intensity above anaerobic threshold on exercise tolerance in patients with heart disease
Scientific Title
Effects of exercise intensity above anaerobic threshold on exercise tolerance in patients with heart disease
Scientific Title:Acronym
Effects of exercise intensity above anaerobic threshold on exercise tolerance in patients with heart disease
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 was to examine the effect of exercise intensity above anaerobic threshold on exercise tolerance in patients with heart disease who visit a cardiac rehabilitation outpatient clinic.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak oxygen intake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Aerobic exercise was performed with an exercise intensity of 1/3 of the anaerobic threshold to the start of respiratory compensation. The period is 3 months. The equipment used is an exercise bike. The frequency was twice a week.
Interventions/Control_2
Aerobic exercise was performed at the anaerobic threshold. The period is 3 months. The equipment used is an exercise bike. The frequency was twice a week.
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cardiac rehabilitation in cardiovascular medicine and cardiovascular surgery
Patients who have received sufficient explanation for participation in this study, and who have fully understood and agreed to the document freely.
Key exclusion criteria
Patients who do not have voluntary consent
Patients judged by doctors and research staff as inappropriate for this study
Patients with large infarct size (CK: 10000 or more)
Patients who still have severe coronary stenosis
Patients with left ventricular ejection fraction of less than 40%
Patients with atrial fibrillation (including mild atrial fibrillation)
Patients with renal dysfunction (serum creatinine 1 or higher) (including dialysis patients)
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tagashira |
| Middle name | |
| Last name | Satoshi |
Organization
Nozaki Tokushukai Hospital
Division name
Department of rehabilitation
Zip code
574-0074
Address
2-10-50 Tanikawa, Daito City, Osaka, Japan
TEL
0728471641
gasira1981@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tagashira |
| Middle name | |
| Last name | Satoshi |
Organization
Nozaki Tokushukai Hospital
Division name
Department of rehabilitation
Zip code
574-0074
Address
2-10-50 Tanikawa, Daito City, Osaka, Japan
TEL
0728471641
Homepage URL
gasira1981@yahoo.co.jp
Sponsor or person
Institute
Medical corporation Tokushukai Nozaki Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Nozaki Tokushukai Hospital Clinical Trials Center
Address
2-10-50 Tanikawa, Daito City, Osaka, Japan
Tel
072-874-1641
gasira1981@yahoo.co.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
| 2019 | Year | 12 | Month | 11 | 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
64
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 10 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044296
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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