UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033430 |
|---|---|
| Receipt number | R000038118 |
| Scientific Title | Effects of supervised exercise therapy in patients with chronic critical limb ischemia |
| Date of disclosure of the study information | 2018/07/23 |
| Last modified on | 2021/01/18 11:38:38 |
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Basic information
Public title
Effects of supervised exercise therapy in patients with chronic critical limb ischemia
Acronym
Effects of supervised exercise therapy in patients with chronic CLI
Scientific Title
Effects of supervised exercise therapy in patients with chronic critical limb ischemia
Scientific Title:Acronym
Effects of supervised exercise therapy in patients with chronic CLI
Region
| Japan |
Condition
Condition
Critical limb ischemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of exercise therapy in patients with chronic critical limb ischemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amputation-free survival
Key secondary outcomes
Time to wound healing
6-min walking distance
Changes in limb hemodynamics such as the ABI and peripheral arterial ultrasound examination
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Exercise intervention group
Interventions/Control_2
Non-exercise control group
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
Stable CLI patients who underwent endovascular revascularization
Key exclusion criteria
Evidence of active infection
Planned revascularization
Other contraindications for exercise therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Ohshima |
Organization
Kaikoukai Healthcare Corporation, Nagoya Kyoritsu Hospital
Division name
Department of Cardiovascular Medicine
Zip code
467-0033
Address
1-172 Hokke, Nakagawa-ku, Nagoya-shi, Aichi 454-0933, JAPAN
TEL
9099176889
kaku@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Ohshima |
Organization
Kaikoukai Healthcare Corporation, Nagoya Kyoritsu Hospital
Division name
Department of Cardiovascular Medicine
Zip code
454-0933
Address
1-172 Hokke, Nakagawa-ku, Nagoya-shi, Aichi 454-0933, JAPAN
TEL
052-362-5151
Homepage URL
kaku@kaikou.or.jp
Sponsor or person
Institute
Kaikoukai Healthcare Corporation, Nagoya Kyoritsu 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
Kaikoukai Nagoya Kyoritsu Hospital
Address
1-172 Hokke, Nakagawa
Tel
052-362-5151
kaku@kaikou.or.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
| 2018 | Year | 07 | Month | 23 | 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
| 2018 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2018 | Year | 07 | Month | 18 | Day |
Last modified on
| 2021 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038118
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
