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 |
Research about psychological factor of unsupervised exercise therapy on Peripheral arterial disease
Research about psychological factor of unsupervised exercise therapy on Peripheral arterial disease
Research about psychological factor of unsupervised exercise therapy on Peripheral arterial disease
Research about psychological factor of unsupervised exercise therapy on Peripheral arterial disease
Japan |
Peripheral arterial disease (PAD)
Vascular surgery |
Others
NO
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.
Efficacy
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.
We measure ventral and dorsal of thigh and lower thigh by echography.
Interventional
Factorial
Randomized
Individual
Open -no one is blinded
No treatment
Numbered container method
4
Educational,Counseling,Training
Behavior,custom |
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.
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.
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.
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.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
100
1st name | |
Middle name | |
Last name | TOSHIHUMI KUDO |
Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Vascular Surgery
1-5-45, Yushima, Bunkyo-ku, Tokyo
03-5803-5261
t-kudo.srg1@tmd.ac.jp
1st name | |
Middle name | |
Last name | TOSHIHUMI KUDO |
Tokyo Medical and Dental University
Vascular Surgery
1-5-45, Yushima, Bunkyo-ku, Tokyo
03-5803-525
t-kudo.srg1@tmd.ac.jp
Tokyo Medical and Dental University
None
Other
NO
東京医科歯科大学(東京都)
2017 | Year | 12 | Month | 25 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 12 | Month | 15 | Day |
2017 | Year | 12 | Month | 25 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 03 | Month | 31 | Day |
2017 | Year | 12 | Month | 25 | Day |
2018 | Year | 01 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034876
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