UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037981 |
|---|---|
| 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 | 2024/07/17 18:20:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of 4 weeks preoperative exercise with blood flow restriction on ischemia reperfusion injury after total knee arthroplasty
Acronym
Efficacy of 4 weeks preoperative exercise with blood flow restriction on ischemia reperfusion injury after total knee arthroplasty
Scientific Title
Efficacy of 4 weeks preoperative exercise with blood flow restriction on ischemia reperfusion injury after total knee arthroplasty
Scientific Title:Acronym
Efficacy of 4 weeks preoperative exercise with blood flow restriction on ischemia reperfusion injury after total knee arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
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.
Interventions/Control_2
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.
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kubo |
Organization
Kobori Orthopedic Clinic
Division name
Department of Rehabilitation Medicine
Zip code
433-8108
Address
548-2 Nearaichou, Kita-ku, Hmamatsu City, Shizuoka
TEL
053-438-3133
yusuke.kubo11@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Kubo |
Organization
Kobori Orthopedic Clinic
Division name
Department of Rehabilitation Medicine
Zip code
433-8108
Address
548-2 Nearaichou, Kita-ku, Hmamatsu City, Shizuoka
TEL
053-438-3133
Homepage URL
yusuke.kubo11@gmail.com
Sponsor or person
Institute
Kobori Orthopedic Clinic
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
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
Seirei Christopher University
Address
3453 Mikataharachou, Kita-ku, Hamamatsu City, Shizuoka
Tel
053-439-1400
somu-office@seirei.ac.jp
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 | 09 | Month | 11 | Day |
Related information
URL releasing protocol
10.7759/cureus.64466
Publication of results
Published
Result
URL related to results and publications
10.7759/cureus.64466
Number of participants that the trial has enrolled
22
Results
The increase in quadriceps strength pre- and post-intervention showed no significant difference between the two groups (BFR group: median 12.1%; LST group: median 6.2%). The reduction in quadriceps strength pre- and post-surgery also showed no significant difference between the two groups (BFR group: mean -72.4%; LST group: mean -75.3%). For safety assessments (D-dimer and hs-CRP levels), there were no significant main effects of time, group, or interaction between the two groups.
Results date posted
| 2024 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
-Age (median): BFR group 73 years, LST group 73 years
-Gender (male, n (%)): Both groups had 2 males (18%)
-Height (m, mean): BFR group 1.5, LST group 1.5
-Weight (kg, mean): BFR group 57, LST group 58
-BMI (kg/m/m, mean): BFR group 24, LST group 25
-Number of preoperative interventions (mean): BFR group 7, LST group 6
-Number of participants who received preoperative intervention at least twice a week (n (%)): Both groups had 4 participants (36%)
-Number of postoperative interventions (median): BFR group 11, LST group 9
Current medical history (n (%)):
-Diabetes: BFR group 1 (9%), LST group 0 (0%)
-Hyperlipidemia: BFR group 4 (36%), LST group 3 (27%)
-Hypertension: BFR group 4 (36%), LST group 5 (45%)
Contralateral knee (OA and TKA, n (%)): Both groups had 9 participants (82%)
-Quadriceps strength (Nm/kg, mean): BFR group 1.29, LST group 1.13
-Tourniquet time (min, median): BFR group 58, LST group 56
Participant flow
In this study, 379 patients were considered for inclusion, but 357 were excluded for the following reasons: 208 did not meet the criteria, 6 canceled their surgeries, 45 declined to participate due to concerns about the new coronavirus infection, and 98 were excluded for other reasons. Ultimately, 22 patients were included in the study and were randomly assigned to either the Low-Load Resistance Training with Blood Flow Restriction (BFR group) or the Low-Intensity Resistance Training with Slow Movement and Tonic Force Generation (LST group). Each group included 11 participants, and all participants successfully completed the study protocol.
Adverse events
none
Outcome measures
-Knee and Thigh Circumferences
-Isometric Quadriceps Strength
-Knee Pain during Quadriceps Strength Testing
-30-second Chair Stand Test
-Timed Up and Go Test
-12-step Stair Climbing Test
-Knee Injury and Osteoarthritis Outcome Score
-Japanese Knee Osteoarthritis Measure (JKOM)
-d-ROMs (Diacron-Reactive Oxygen Metabolites)
-BAP (Biological Antioxidant Potential)
-Interleukin-6
-D-dimer
-High-Sensitivity C-Reactive Protein
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043295
