UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014086 |
|---|---|
| Receipt number | R000016361 |
| Scientific Title | The effect of resistance exercise with proior or subsequent aerobic exercise on lactic blood level in patients with heart failure |
| Date of disclosure of the study information | 2014/05/27 |
| Last modified on | 2014/05/27 19:31:05 |
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Basic information
Public title
The effect of resistance exercise with proior or subsequent aerobic exercise on lactic blood level in patients with heart failure
Acronym
The effect of resistance exercise with proior or subsequent aerobic exercise on lactic blood level in patients with heart failure
Scientific Title
The effect of resistance exercise with proior or subsequent aerobic exercise on lactic blood level in patients with heart failure
Scientific Title:Acronym
The effect of resistance exercise with proior or subsequent aerobic exercise on lactic blood level in patients with heart failure
Region
| Japan |
Condition
Condition
healthy men
patiens with heart failure
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the purpose of this study is to review existing exercise program by examining the effect of resistance exercise with prior or subsequent aerobic exercise on lactic blood level in healthy subjects, and to consider steps to prescribe a safe and effective exercise program to meet patients with heart failure need
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to provide patients with heart failure exercise training safely and effectively
Key secondary outcomes
blood pressure, Borg scale, heart rate, double product, blood lactic acid
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
resistance exercise with prior aerobic exercise
Interventions/Control_2
resistance exercise with subsequent aerobic exercise
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Study1: Healthy men who were informed about the experimental procedure and the porpose of this study
Study2: stable New York Heart Association (NYHA)class 1-3 heart failure patients
Key exclusion criteria
patients who don't agree with collecting their blood sample or have abnormal blood clotting.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Koie |
Organization
fukui university hospital
Division name
rehabilitation
Zip code
Address
23-3 Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
TEL
0776-61-8676
yusukekoie@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Koie |
Organization
fukui university hospital
Division name
department of rehabilitation medicine
Zip code
Address
23-3 Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
TEL
0776-61-8676
Homepage URL
yusukekoie@gmail.com
Sponsor or person
Institute
Fukui university hospital
Department of rehabilitation medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 05 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 27 | Day |
Last modified on
| 2014 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016361
