Unique ID issued by UMIN | UMIN000043356 |
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Receipt number | R000049502 |
Scientific Title | Clinical trial for effectiveness of the video-based home exercise on outcomes for subjects with osteoarthritis of the knee |
Date of disclosure of the study information | 2021/04/01 |
Last modified on | 2023/08/22 12:27:52 |
Clinical trial for effectiveness of the video-based home exercise on outcomes for subjects with osteoarthritis of the knee
Clinical trial for effectiveness of the video-based home exercise on outcomes for subjects with osteoarthritis of the knee
Clinical trial for effectiveness of the video-based home exercise on outcomes for subjects with osteoarthritis of the knee
EVOK trial
Japan |
osteoarthritis of the knee
Rehabilitation medicine |
Others
NO
To test the hypothesis that video-based home exercise could enhance adherence exercise and improvement in pain, physical function and QOL in patients with knee OA, and also prevent radiographic progression of knee OA compared with conventional home exercise without video media
Efficacy
pain (WOMAC), function (WOMAC)
QOL(SF-8), radiological evaluation of OA progression
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Maneuver |
Video-based exercise
Quadriceps home-exercise
50 | years-old | <= |
80 | years-old | >= |
Male and Female
-Radiographic osteoarthritis changes of the knee equivalent to Kellgren-Lawrence Grade 2, 3, or 4.
-Symptomatic gonarthrosis for a minimum of 3 months
(1) Other pathology is explaining the complaints.
(2) Treatment for these complaints at another hospital or clinic within 4 weeks before the day of agreement to enter the trial.
(3) Indication for hip or knee replacement.
(4) Regular or intermittent use of oral steroid or non-steroid anti-inflammatory drug (NSAID) within 4 weeks before the day of agreement to enter the trial.
(5) Regular or intermittent intraarticular injection or aspiration of joint fluid within 4 weeks before the day of agreement to enter the trial.
(6) Contraindication for exercise due to the physical or mental problem.
100
1st name | Harukazu |
Middle name | |
Last name | Tohyama |
Hokkaido University
Faculty of Health Sciences
060-0812
Kita-12 Nishi-5 Kita-ku, Sapporo, Hokkaido
011-706-3393
tohyama@med.hokudai.ac.jp
1st name | Harukazu |
Middle name | |
Last name | Tohyama |
Hokkaido University
Faculty of Health Sciences
060-0812
Kita-12 Nishi-5 Kita-ku, Sapporo, Hokkaido
011-706-3393
tohyama@med.hokudai.ac.jp
Hokkaido University
Self funding
Self funding
Hokkaido University, Faculty of Health Sciences
Kita-12 Nishi-5 Kita-ku, Sapporo, Hokkaido
7067211
tohyama@med.hokudai.ac.jp
NO
北海道
2021 | Year | 04 | Month | 01 | Day |
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000049502
Unpublished
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000049502
71
The improvements in pain, stiffness and physical function categories of WOMAC were significantly greater in the video-based exercise group than in the control group at all time periods. Regarding radiographic OA progression, video-based exercise group showed significant increase in FTA at 12- and 24-month compared with the baseline, while we could not find significant progression in other parameters.
2023 | Year | 08 | Month | 22 | Day |
For the video-based exercise (3 males, 49 females) and the control (4 males, 23 females) groups, the age was 65.8+/-6.8 years old and 68.8+/-7.2 years old, respectively. Concerning radiographic OA grade (Kellgren-Lawrence), Grade-2, -3 and -4 were 9 cases, 41 cases, and 1 case in the video-based exercise group, while Grade-2, -3 and -4 were 9 cases, 20 cases, and 1 case in the control group, respectively. There was no significant difference in sex, age, or radiographic OA grade between the video-based exercise and the control groups.
From the 79 patients included in the study, 4(7.4%) and 4(14.8%) of the participants were lost to follow-up at 24 months in the video-based home-exercise and control groups, respectively.
In the video-based home-exercise group, 5(9.6%), 3(5.8%) and 1(1.9%) subjects underwent intraarticular injection of hyaluronic acid, arthroscopic debridement and total knee replacement, respectively. In the control group, 2(7.4%) and 2(7.4%) underwent intraarticular injection of hyaluronic acid and arthroscopic debridement, respectively. These patients who underwent other treatments during the study period were excluded from the analyses.
Concerning WOMAC pain score, a significant improvement was noted at 6-month, 12-month and 24-month in the video-based exercise group compared to the base line. The improvement from baseline value was significantly greater in the video-based exercise group than the control group. WOMAC stiffness score was also significant greater improvement in the video-based exercise group compared to the control group (6-month: p=0.0001, 12-month: p=0.0001, 24-month: p=0.0457. There were significant changes from baseline value in the video-based exercise group at 6-month, 12-month and 24-month (6-month: p=0.0009, 12-month: p=0.0053, 24-month: p=0.0210). WOMAC physical functional score significantly improved at 6-month, 12-month and 24-month in the video-based exercise group compared to the base line. The improvement from baseline value was significantly greater in the video-based exercise group than the control group (6-month: p=0.0001, 12-month : p=0.0001, 24-month : 0.0277).
Concerning radiographic OA progression, there was a significant increase in FTA from the baseline value in the video-based exercise group at the 12-month and 24-month (12-month: p=0.0058, 24-month: p=0.0211), while there were no significant changes in the control group (12-month: p=0.2378, 24-month: p=0.2760)(Table 3). There was no significant changes between the video-based exercise and the control groups (12-month: p=0.4345, 24-month: p=0.6795). For the JSA, the mJSW or osteophyte area of the medial tibia, there was no significant progression from the base line at 12-month or 24-month.
No longer recruiting
2008 | Year | 09 | Month | 01 | Day |
2021 | Year | 04 | Month | 01 | Day |
2008 | Year | 10 | Month | 01 | Day |
2022 | Year | 03 | Month | 31 | Day |
2021 | Year | 02 | Month | 17 | Day |
2023 | Year | 08 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049502
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