Unique ID issued by UMIN | UMIN000037981 |
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Receipt number | R000043295 |
Scientific Title | Efficacy of 4 weeks preoperative exercise with blood flow restriction on ischemia reperfusion injury after total knee arthroplasty |
Date of disclosure of the study information | 2019/09/11 |
Last modified on | 2023/09/17 17:16:24 |
Efficacy of 4 weeks preoperative exercise with blood flow restriction on ischemia reperfusion injury after total knee arthroplasty
Efficacy of 4 weeks preoperative exercise with blood flow restriction on ischemia reperfusion injury after total knee arthroplasty
Efficacy of 4 weeks preoperative exercise with blood flow restriction on ischemia reperfusion injury after total knee arthroplasty
Efficacy of 4 weeks preoperative exercise with blood flow restriction on ischemia reperfusion injury after total knee arthroplasty
Japan |
Osteoarthritis of the knee
Orthopedics | Rehabilitation medicine |
Others
NO
The purpose of this study is to clarify the efficacy of 4 weeks preoperative exercise with blood flow restriction in patients waiting for total knee arthroplasty.
Efficacy
The primary outcome is quadriceps muscle strength. All patients included in the study are assessed 5 times: tests are performed 6 weeks and 1 week before surgery, 4 days, 1 month and 3 months after surgery.
The secondary outcomes are inflammatory response immediately after surgery, knee swelling, knee range of motion, performance test, knee injury and osteoarthritis outcome score (KOOS), and Japanese knee osteoarthritis measure (JKOM).
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Placebo
2
Treatment
Other |
The exercise contents of the intervention group are a squat, a forward lunge, bilateral leg extension with blood flow restriction and cycle ergometer training. These exercises are performed once or twice a week for 4 weeks before surgery. After surgery, standard exercise is performed once or twice a week for 12 weeks.
The exercise contents of the control group are a squat, a forward lunge, bilateral leg extension without blood flow restriction and cycle ergometer training. These exercises are performed once or twice a week for 4 weeks before surgery. After surgery, standard exercise is performed once or twice a week for 12 weeks.
60 | years-old | <= |
80 | years-old | > |
Male and Female
1. Japanese males and females
2. between 60 and 79 years old
3. primary knee osteoarthritis
4. radiographic severity classified using Kellgren-Lawrence System was grade 3 to grade 4
1. patients with serious heart disease, respiratory disease, and diabetes
2. history of neurological disease, and peripheral artery disease
3. patients with abnormalities of blood coagulation and fibrinolysis
4. smoker
5. patients who cannot exercise due to knee pain
46
1st name | Yusuke |
Middle name | |
Last name | Kubo |
Kobori Orthopedic Clinic
Department of Rehabilitation Medicine
433-8108
548-2 Nearaichou, Kita-ku, Hmamatsu City, Shizuoka
053-438-3133
yusuke.kubo11@gmail.com
1st name | Yusuke |
Middle name | |
Last name | Kubo |
Kobori Orthopedic Clinic
Department of Rehabilitation Medicine
433-8108
548-2 Nearaichou, Kita-ku, Hmamatsu City, Shizuoka
053-438-3133
yusuke.kubo11@gmail.com
Kobori Orthopedic Clinic
The Ministry of Education, Culture, Sports, Science and Technology
Japanese Governmental office
Seirei Christopher University
3453 Mikataharachou, Kita-ku, Hamamatsu City, Shizuoka
053-439-1400
somu-office@seirei.ac.jp
NO
2019 | Year | 09 | Month | 11 | Day |
Unpublished
22
Delay expected |
The duration of the study has been extended beyond the planned duration.
No longer recruiting
2019 | Year | 05 | Month | 25 | Day |
2019 | Year | 07 | Month | 04 | Day |
2019 | Year | 09 | Month | 10 | Day |
2021 | Year | 03 | Month | 31 | Day |
2019 | Year | 09 | Month | 10 | Day |
2023 | Year | 09 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043295
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