UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041851 |
|---|---|
| Receipt number | R000047707 |
| Scientific Title | Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2020/09/20 14:46:33 |
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Basic information
Public title
Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities
Acronym
Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities
Scientific Title
Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities
Scientific Title:Acronym
Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities
Region
| Japan |
Condition
Condition
peripheral arterial disease of the lower extremities
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of a comprehensive outpatient cardiovascular disease rehabilitation program intervention after endovascular treatment for cases of peripheral arterial disease of the lower extremities on renal function, physical activity and gait function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physical function assessment : 6-Minute Walk Test, grip of hand, knee extension strength, pain-free walking distance, claudication onset time, maximum walking distance, peak walking time, Walking Impairment Questionnaire
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
supervised exercise therapy
Interventions/Control_2
conventional therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with Fontain Class II peripheral artery disease of the lower extremities and admitted to Aomori Kyoritsu Hospital for endovascular treatment
(2) Patients who had been making regular outpatient visits at the same facility for at least 3 months prior to endovascular treatment
(3) Patients who regularly visit the same facility as an outpatient for more than 3 months after discharge from the hospital.
(4) Patients who have been provided with an explanation of the research and whose written consent has been obtained from them.
Key exclusion criteria
(1) Patients who are not able to walk independently
(2) Patients with critical limb ischemia
(3) Dialysis patients
(4) Patients with a diagnosis of dementia prior to discharge
(5) Patients with untreated coronary artery disease
(6) Patients with grade III or greater heart failure according to NYHA cardiac function classification
(7) Patients with severe chronic obstructive pulmonary disease
(8) Patients with poorly controlled diabetes
(9) Patients with outflow tract stenosis due to aortic stenosis or hypertrophic cardiomyopathy or other diseases.
(10) Patients with advanced atrioventricular block who have not had a pacemaker implanted.
(11) Other patients who are deemed by the attending physician to be an undesirable subject for this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | MASAHIRO |
| Middle name | |
| Last name | KOHZUKI |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine & Rehabilitation Science Disability Science
Zip code
980-8574
Address
1-1, Seiryo-cho, Aoba-ku Sendai
TEL
022-717-7351
kohzuki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | TAKAYUKI |
| Middle name | |
| Last name | NAITO |
Organization
Aomori Kyoritsu Hospital
Division name
Internal Medicine
Zip code
030-0847
Address
2-1-10 Higashi-Ohno, Aomori City
TEL
017-762-5500
Homepage URL
takatakanaitou@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University
Address
1-1, Seiryo-cho, Aoba-ku Sendai
Tel
022-717-7351
takatakanaitou@med.tohoku.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
あおもり協立病院（青森県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 01 | 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
| 2020 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 20 | Day |
Last modified on
| 2020 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047707
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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