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 2023/09/17 17:16:24

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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

Email

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


Email

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

Email

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


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

22

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

The duration of the study has been extended beyond the planned duration.

Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

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

2023 Year 09 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043295


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name