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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030550
Receipt No. R000034876
Scientific Title Research about psychological factor of unsupervised exercise therapy on Peripheral arterial disease
Date of disclosure of the study information 2017/12/25
Last modified on 2018/01/15

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Basic information
Public title Research about psychological factor of unsupervised exercise therapy on Peripheral arterial disease
Acronym Research about psychological factor of unsupervised exercise therapy on Peripheral arterial disease
Scientific Title Research about psychological factor of unsupervised exercise therapy on Peripheral arterial disease
Scientific Title:Acronym Research about psychological factor of unsupervised exercise therapy on Peripheral arterial disease
Region
Japan

Condition
Condition Peripheral arterial disease (PAD)
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify how participants are psychologically affected and how their exercise behavior change with a pedometer, a menu of resistance training for walking and by co-medical stuff's encouragement in addition to physician's advice.
The second purpose of this study is to show current status of skeletal muscles of lower limbs indispensable for daily life in patients with PAD because they are usually elderly, and their physical activity is reported to be decreased.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We use "medical questionnaire" "VascuQOL-6" "Perceived Benefit and Barrier to Exercise Scale Short Version" and ankle-brachial pressure index(ABI) to evaluate the outcome.
Key secondary outcomes We measure ventral and dorsal of thigh and lower thigh by echography.

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Case of "Only pedometer"
Laboratory stuff encourage the patients of this group to walk, give them a pedometer telling them to use it next 6 months.
Interventions/Control_2 Case of "Pedometer and walking -recording sheet"
Laboratory stuff encourage the patients of this group to walk and give them steps-recording sheets as well as a pedometer. The patients tell them to fill in daily steps and bring back the sheets when visiting the hospital after 3 and 6 months.
Interventions/Control_3 Case of "Pedometer and document of resistance training"
Laboratory stuff encourage the patients of this group to walk and give them a resistance training menu besides a resistance training-recording sheets and a pedometer. The patients encircle the date when they do resistant training, and bring back the sheets when visiting the hospital after 3 and 6 months.
Interventions/Control_4 Case of "Pedometer, walking-recording sheet and resistance training menu"
Laboratory stuff encourage the patients of this group to walk and give them a pedometer, resistance training menu and steps-recording sheets. The patients fill in daily steps and encircle the date when they do resistant training, and bring back the sheets when visiting the hospital after 3 and 6 months.
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 PAD are diagnosed by ABI less than 1.0, and patients are classified into Fontaine 1 to 4 degrees at the vascular surgery laboratory, Tokyo Medical and Dental University Hospital. Participants in this study must be aged 20 years or more. All patients are required to be able to walk by themselves. Patients of Fontaine 3 or 4 undergo vascular intervention therapy, thereafter, they entry this study, if they meet at least one of conditions as follows (1)ankle pressure more than 30 mm Hg (2)toe pressure more than 30 mm Hg (3)tcPO2 more than 30 mm Hg (4)SPP more than 40 mm Hg.
Key exclusion criteria Those that fall under any of the following conditions are not considered.
1) At the time of obtaining consent, the age is under 20
2) Patients with severe heart disease or who are in shock (systolic blood pressure less than 90 mmHg)
3) Patients who have severe respiratory illness and require oxygen inhalation or ventilator management
4) Patients with severe liver disease (AST (GOT) or ALT (GTP)> 100 U)
5) Women who may be pregnant or have a possibility of pregnancy
6) Women who are breastfeeding
7) Difficult cases of self-determination right (dementia, consciousness disturbance, etc.)
8) Patients who are difficult to walk (Caused by outside of vascular disease or orthopedic disease, etc.)
9) Patients judged unsuitable as research subjects by Research doctors
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TOSHIHUMI KUDO
Organization Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Division name Vascular Surgery
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5261
Email t-kudo.srg1@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name TOSHIHUMI KUDO
Organization Tokyo Medical and Dental University
Division name Vascular Surgery
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-525
Homepage URL
Email t-kudo.srg1@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
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 東京医科歯科大学(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 25 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
2017 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 25 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
2019 Year 02 Month 28 Day
Date trial data considered complete
2019 Year 02 Month 28 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 25 Day
Last modified on
2018 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034876

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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