UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026424
Receipt number R000030356
Scientific Title Effectiveness of High Intensity Exercises for improvement of Stair Climbing in Patients Undergone Total Knee Arthroplasty
Date of disclosure of the study information 2017/03/06
Last modified on 2018/03/07 09:10:12

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Basic information

Public title

Effectiveness of High Intensity Exercises for improvement of Stair Climbing in Patients Undergone Total Knee Arthroplasty

Acronym

Effectiveness of High Intensity Exercises after Total Knee Arthroplasty

Scientific Title

Effectiveness of High Intensity Exercises for improvement of Stair Climbing in Patients Undergone Total Knee Arthroplasty

Scientific Title:Acronym

Effectiveness of High Intensity Exercises after Total Knee Arthroplasty

Region

Japan


Condition

Condition

Knee Osteoarthritis

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Many of patients who had undergone total knee arthroplasty (TKA) remain of difficulty of stair climbing. Quadriceps muscle weakness is one of this reason. We hypothesize that high-intensity exercises are effective to improve quadriceps. The purpose of this study is to clarify effectiveness of high intensity exercises after total knee arthroplasty.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Japanese version Western Ontario and McMaster Universities Osteoarthritis Index

Key secondary outcomes

Knee extension torque
Knee range of motion
Chair-standing test
Japanese version High-Activity Arthroplasty Score
Japanese version Forgotten Joint Score


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

High intensity exercises (muscle strengthening, balance, endurance training)
12 weeks, 1 or 2 times per week, 60-90 minutes per day

Interventions/Control_2

Standard exercises (muscle strengthening, balance, ADL training)
12 weeks, 1 or 2 times per week, 60-90 minutes per day

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

Osteoarthritis
primary surgery
PCL retaining type implant
unilateral or bilateral surgery

Key exclusion criteria

5 of 10 or more at rest pain
severe cardiovascular or nervous system disease
musculoskeletal disorder
cognitive disease

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sadaya MISAKI

Organization

Sonodakai Joint Replacement Center Hospital

Division name

Department of Rehabilitation Medicine

Zip code


Address

1-21-10, Hokima, Adachi, Tokyo

TEL

03-5831-1811

Email

s_misaki@sonodakai.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sadaya MISAKI

Organization

Sonodakai Joint Replacement Center Hospital

Division name

Department of Rehabilitation Medicine

Zip code


Address

1-21-10, Hokima, Adachi, Tokyo

TEL

03-5831-1811

Homepage URL


Email

s_misaki@sonodakai.or.jp


Sponsor or person

Institute

Sonodakai Joint Replacement Center Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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


Address


Tel


Email



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 03 Month 06 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


Results


Results date posted


Results Delayed


Results Delay Reason


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

Completed

Date of protocol fixation

2015 Year 05 Month 22 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 01 Day

Last follow-up date

2018 Year 03 Month 07 Day

Date of closure to data entry

2018 Year 03 Month 07 Day

Date trial data considered complete

2018 Year 03 Month 07 Day

Date analysis concluded

2018 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 03 Month 06 Day

Last modified on

2018 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030356


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name