UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028140 |
|---|---|
| Receipt number | R000032211 |
| Scientific Title | The effect of n-3 unsaturated fatty acids supplementation on quadriceps muscle weakness after total knee arthroplasty. |
| Date of disclosure of the study information | 2017/07/11 |
| Last modified on | 2024/07/15 23:26:50 |
* 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
The effect of n-3 unsaturated fatty acids supplementation on quadriceps muscle weakness after total knee arthroplasty.
Acronym
The effect of n-3 unsaturated fatty acids supplementation on quadriceps muscle weakness after total knee arthroplasty.
Scientific Title
The effect of n-3 unsaturated fatty acids supplementation on quadriceps muscle weakness after total knee arthroplasty.
Scientific Title:Acronym
The effect of n-3 unsaturated fatty acids supplementation on quadriceps muscle weakness after total knee arthroplasty.
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effectiveness of n-3 unsaturated fatty acids 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 2 times: tests are performed 1 month before surgery and 4 days after surgery.
Key secondary outcomes
The secondary outcomes are oxidative stress, polyunsaturated fatty acid in serum, knee swelling, knee pain.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention group take a daily supplements with n-3 unsaturated fatty acids(EPA645mg & DHA215mg) from 30 days prior to surgery.
Interventions/Control_2
none
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
| 79 | 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 and diabetes
2. history of rheumatoid arthritis, neurological disease, and peripheral artery disease
3. patients who are taking Warfarin and n-3 unsaturated fatty acids supplements
4. smoker
5. patients with exercise habits
Target sample size
30
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
4338108
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
4338108
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
Seirei Christopher University
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
Seirei Christopher University
Address
3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka 433-8558 Japan
Tel
+81-53-439-1400
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
| 2017 | Year | 07 | Month | 11 | Day |
Related information
URL releasing protocol
https://doi.org/10.1589/jpts.35.93
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1589/jpts.35.93
Number of participants that the trial has enrolled
20
Results
-In the intervention group, the (EPA+DHA)/arachidonic acid ratio significantly increased after the intervention.
-The intervention group showed a significantly lower rate of quadriceps muscle strength loss before and after surgery compared to the control group.
-There were no significant differences between the groups in the rate of change in oxidative stress, knee pain during quadriceps strength testing, and swelling of the knee joint and thigh.
Results date posted
| 2024 | Year | 07 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age: The median age in the intervention group was 69 years, and in the control group, it was 73 years.
Gender: Both groups had 2 males and 8 females.
BMI: The median BMI in the intervention group was 25 kg/m/m, and in the control group, it was 26 kg/m/m.
EPA: The median EPA level in the intervention group was 158 ug/mL, and in the control group, it was 64 ug/mL.
DHA: The median DHA level in the intervention group was 180 ug/mL, and in the control group, it was 137 ug/mL.
(EPA+DHA)/Arachidonic Acid Ratio: The median ratio in the intervention group was 1.4, and in the control group, it was 1.0.
Diabetes: 0 participants in the intervention group, 2 in the control group.
Hyperlipidemia: 4 participants in the intervention group, 5 in the control group.
Hypertension: 6 participants in the intervention group, 7 in the control group.
JKOM Score: The median score in the intervention group was 42 points, and in the control group, it was 41 points.
Tourniquet Time: The median tourniquet time in the intervention group was 62 minutes, and in the control group, it was 59 minutes.
Participant flow
Of the 317 patients who were scheduled to undergo unilateral total knee arthroplasty between September 2017 and July 2019, 297 were excluded based on the inclusion and exclusion criteria. Ultimately, 20 participants (10 in the intervention group and 10 in the control group) underwent all pre- and postoperative assessments, and all participants in the intervention group completed the intervention.
Adverse events
none
Outcome measures
-DHA
-EPA
-Arachidonic Acid
-Quadriceps Muscle Strength
-Oxidative Stress (Derivatives of Reactive Oxygen Metabolites: d-ROMs)
-Thigh Circumference
-Knee Pain During Quadriceps Strength Testing
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 07 | Day |
Last modified on
| 2024 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032211
