UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial to establish optimal exercise therapy using near infrared spectroscopy(NIRS) to monitor Skeletal Muscle Oxygen Saturation(StO2) in patients with chronic limb ischemia
Acronym	Clinical trial to establish optimal exercise therapy using near infrared spectroscopy(NIRS) to monitor Skeletal Muscle Oxygen Saturation(StO2) in patients with chronic limb ischemia
Scientific Title	Clinical trial to establish optimal exercise therapy using near infrared spectroscopy(NIRS) to monitor Skeletal Muscle Oxygen Saturation(StO2) in patients with chronic limb ischemia
Scientific Title:Acronym	Clinical trial to establish optimal exercise therapy using near infrared spectroscopy(NIRS) to monitor Skeletal Muscle Oxygen Saturation(StO2) in patients with chronic limb ischemia
Region	Japan

Condition
Condition	Chronic limb ischemia
Classification by specialty	Cardiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and safety of optimal exercise therapy in patients with Rutherford 4 or 5 chronic limb ischemia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of changes in maximum walking distance 6 months after revascularization treatment from registration.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	The optimal exercise therapy Fixation exercise therapy is performed from the day after revascularization therapy, and optimal exercise therapy is started on 7th day after the treatment. Optimal exercise therapy is based on the treadmill walking test and the evaluation of the hemodynamics by NIRS. The optimal exercise prescription is the walking speed of 80% of the walking speed at the end of treadmill walking test. Determination of optimal exercise therapy is at 7th day, 1st, 2nd, 3rd, 6th month after revascularization therapy. The amount of exercise is monitored and management using ACT watch during protocol period. The optimal exercise therapy group should receive exercise instruction about once a week.
Interventions/Control_2	Traditional exercise therapy The standard therapy (foot stretching, gymnastics, ankle exercise, etc.) that is required for critical limb ischemia is performed during hospitalization and instructed before discharge. After that, visit the hospital for the same period as optimal exercise therapy group, and receive instruction about exercise therapy. The amount of exercise is monitored and management using ACT watch during protocol period.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Male or female patients who aged 20 years or older and under 80 years of age at the time of signed informed consent form 2) Patients Who are scheduled to register for "regenerative therapy using mononuclear cells" or "regenerative therapy using autologous bone marrow mononuclear cells" under the act on the safety of regenerative medicine 3) Patients with Chronic limb ischemia whose Rutherford Classification is 4 or 5 4) Patient with measurable using NIRS at a designated site. 5) Patients who signed document consent of study participation obtained based on the patient's will and / or families' understanding and consent after receiving sufficient explanation about advantage/disadvantage arising from performing exercise therapy and advantage/disadvantage arising from not performing exercise therapy
Key exclusion criteria	1) Even if the disease or the surgical procedure is appropriate, informed consent can not be obtained from the patient, or patient's family need emotional consideration and it is difficult to adapt 2) Patients with life expectancy likely to be within one year due to complications 3) The untreated limb is Fontaine Classification III or more 4) Patient with active cancer treatment 5) Patient with ischemic heart disease who are not performed revascularization 6) Patients with untreated severe diabetic retinopathy 7) Patients with sever infection 8) Patients with significant liver impairment, significant renal impairment (except chronic maintenance dialysis) 9) Severe hematological disorder such as leucopenia and thrombocytopenia, and severe anemia requiring blood transfusions 10) Women who are pregnant or may be pregnant or lactating 11) Patients who have other severe acute / chronic medical / mental conditions or clinical laboratory test abnormalities, and there is a possibility that the risk may increase due to participation in the present study, or there is a possibility that it may affect interpretation of the result 12) Patients who can not be performed exercise therapy sufficiently due to cerebrovascular disease, bone nerve disease, lower limb amputation 13) Patients who the investigator or subinvestigator judged ineligible for the present study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Satoaki Matoba
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Cardiovascular Medicine
Zip code
Address	465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL	075-251-5511
Email	matoba@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kenji Yanishi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Cardiovascular Medicine
Zip code
Address	465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL	075-251-5511
Homepage URL
Email	yanishi@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 03 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	Open public recruiting
Date of protocol fixation	2018 Year 12 Month 05 Day
Date of IRB	2019 Year 03 Month 12 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2023 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2018 Year 12 Month 17 Day
Last modified on	2022 Year 03 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039336