UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043356
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

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Basic information

Public title

Clinical trial for effectiveness of the video-based home exercise on outcomes for subjects with osteoarthritis of the knee

Acronym

Clinical trial for effectiveness of the video-based home exercise on outcomes for subjects with osteoarthritis of the knee

Scientific Title

Clinical trial for effectiveness of the video-based home exercise on outcomes for subjects with osteoarthritis of the knee

Scientific Title:Acronym

EVOK trial

Region

Japan


Condition

Condition

osteoarthritis of the knee

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pain (WOMAC), function (WOMAC)

Key secondary outcomes

QOL(SF-8), radiological evaluation of OA progression


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Video-based exercise

Interventions/Control_2

Quadriceps home-exercise

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

50 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

-Radiographic osteoarthritis changes of the knee equivalent to Kellgren-Lawrence Grade 2, 3, or 4.
-Symptomatic gonarthrosis for a minimum of 3 months

Key exclusion criteria

(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.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Harukazu
Middle name
Last name Tohyama

Organization

Hokkaido University

Division name

Faculty of Health Sciences

Zip code

060-0812

Address

Kita-12 Nishi-5 Kita-ku, Sapporo, Hokkaido

TEL

011-706-3393

Email

tohyama@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Harukazu
Middle name
Last name Tohyama

Organization

Hokkaido University

Division name

Faculty of Health Sciences

Zip code

060-0812

Address

Kita-12 Nishi-5 Kita-ku, Sapporo, Hokkaido

TEL

011-706-3393

Homepage URL


Email

tohyama@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido University, Faculty of Health Sciences

Address

Kita-12 Nishi-5 Kita-ku, Sapporo, Hokkaido

Tel

7067211

Email

tohyama@med.hokudai.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

北海道


Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 01 Day


Related information

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000049502

Publication of results

Unpublished


Result

URL related to results and publications

https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000049502

Number of participants that the trial has enrolled

71

Results

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.

Results date posted

2023 Year 08 Month 22 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

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.

Participant flow

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.

Adverse events

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.

Outcome measures

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.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2008 Year 09 Month 01 Day

Date of IRB

2021 Year 04 Month 01 Day

Anticipated trial start date

2008 Year 10 Month 01 Day

Last follow-up date

2022 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

2021 Year 02 Month 17 Day

Last modified on

2023 Year 08 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049502


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name