UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002924 |
|---|---|
| Receipt number | R000002664 |
| Scientific Title | The effect of resistance exercise on the skeletal muscle energy metabolism in patients with chronic heart failure |
| Date of disclosure of the study information | 2011/07/14 |
| Last modified on | 2012/06/21 11:44:22 |
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Basic information
Public title
The effect of resistance exercise on the skeletal muscle energy metabolism in patients with chronic heart failure
Acronym
The resistance exercise in patients with chronic heart failure
Scientific Title
The effect of resistance exercise on the skeletal muscle energy metabolism in patients with chronic heart failure
Scientific Title:Acronym
The resistance exercise in patients with chronic heart failure
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the skeletal muscle energy metabolism during the resistnace exercise in patients with chronic heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes in phosphocreatine measured by magnetic resonance apectroscopy during the resistance exercise
Key secondary outcomes
The changes in pH measured by magnetic resonance apectroscopy during the resistance exercise
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
chronic heart failure
Interventions/Control_2
control
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
| 75 | years-old | > |
Gender
Male
Key inclusion criteria
Patients with chronic heart failure (NYHA I-III)
Key exclusion criteria
1 chronic heart failure patients with NYHA IV
2 patients and subjects with the restriction of leg exercise
3 patients with angina pectoris
4 patients with uncontroled hypertension
5 patients with varicose vein, thrombophlebitis and deep vein thrombosis
6 patients with arteriosclerosis obliterans
7 patients and subjects with unsuitable for MRS examination
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutsui Hiroyuki |
Organization
Hokkaido Unversity School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
011-706-6973
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kinugawa Shintaro |
Organization
Hokkaido University School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
011-706-6973
Homepage URL
tuckahoe@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Unversity School of Medicine, Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Unversity School of Medicine, Cardiovascular Medicine
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
| 2011 | Year | 07 | Month | 14 | 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
Completed
Date of protocol fixation
| 2009 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | 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
| 2009 | Year | 12 | Month | 21 | Day |
Last modified on
| 2012 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002664
