UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030550
Receipt number 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 11:41:04

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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 or person

Institute

Tokyo Medical and Dental University

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


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

Value
https://center6.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