UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046684
Receipt number R000053247
Scientific Title Effect of aerobic exercise using an upper limb ergometer in combination with standard physical therapy after total knee arthroplasty on prevention of chronic post-surgical pain - A randomized controlled trial.
Date of disclosure of the study information 2022/01/20
Last modified on 2022/03/10 17:49:42

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Basic information

Public title

Effect of upper limb cycling exercise in combination with standard physical therapy after total knee arthroplasty on prevention of chronic pain.

Acronym

Effect of upper limb cycling exercise on prevention of chronic pain after total knee arthroplasty.

Scientific Title

Effect of aerobic exercise using an upper limb ergometer in combination with standard physical therapy after total knee arthroplasty on prevention of chronic post-surgical pain - A randomized controlled trial.

Scientific Title:Acronym

Effect of aerobic exercise using an upper limb ergometer after total knee arthroplasty on prevention of chronic post-surgical pain.

Region

Japan


Condition

Condition

Patients with knee osteoarthritis scheduled for primary, unilateral total knee arthroplasty.

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the effectiveness of aerobic exercise using an upper limb ergometer in combination with standard physical therapy after total knee arthroplasty in preventing chronic post-surgical pain.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of chronic post-surgical pain at 6 months after surgery (Visual analog scale; VAS>30mm).

Key secondary outcomes

Pain intensity during walking (Visual analog scale; VAS), Knee joint range of motion (flexion and extension), knee joint extension muscle strength, Hospital Anxiety and Depression Scale (HADS) and Pain Catastrophizing Scale (PCS) at 1, 2 and 3 weeks and 6 months after surgery.
Physical activity intensity measured by accelerometer at 1, 2 and 3 weeks after surgery.
Pressure pain thresholds (PPT), Temporal summation of pain (TSP), Conditioned pain modulation (CPM), Time up and go test (TUGT) and 10-meter walk test at 2 and 3 weeks and 6 months after surgery.
6-minute walking distance and Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 weeks and 6 months after surgery.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

In addition to standard physical therapy, aerobic exercise using an upper limb ergometer is performed from postoperative day 2 to 14. The intensity of exercise is equivalent to the Modified Borg Scale 5-6 or 40-59% heart rate reserve (HRR), and the duration of exercise is 10 minutes once a day from postoperative day 2 to 7, and 10 minutes twice a day from postoperative day 8 to 14 (total of 20 minutes).

Interventions/Control_2

Standard postoperative physical therapy.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients diagnosed with knee osteoarthritis scheduled for primary, unilateral total knee arthroplasty at the research institute.

Key exclusion criteria

Patients who have difficulty walking independently before surgery, who deviated significantly from our clinical path due to postoperative complications, who have severe orthopedic diseases in the upper limbs or lower limbs other than the knee joint, who have neurological symptoms such as sensory impairment or motor paralysis, who have dementia or psychiatric diseases, who have serious respiratory diseases or cardiovascular diseases, and who have not consented to this research.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Junya
Middle name
Last name Sakamoto

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Physical Therapy Science, Medical and Dental Sciences

Zip code

852-8520

Address

1-7-1 Sakamoto, Nagasaki, Japan

TEL

095-819-7964

Email

jun-saka@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Junya
Middle name
Last name Sakamoto

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Physical Therapy Science, Medical and Dental Sciences

Zip code

852-8520

Address

1-7-1 Sakamoto, Nagasaki, Japan

TEL

095-819-7964

Homepage URL


Email

jun-saka@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University Graduate School of Biomedical Sciences

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

Japanese Red Cross Nagasaki Genbaku Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee

Address

1-7-1 Sakamoto, Nagasaki, Japan

Tel

095-819-7198

Email

hirano@nagasaki-u.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

日本赤十字社 長崎原爆病院(長崎県)
Japanese Red Cross Nagasaki Genbaku Hospital


Other administrative information

Date of disclosure of the study information

2022 Year 01 Month 20 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

Open public recruiting

Date of protocol fixation

2021 Year 07 Month 19 Day

Date of IRB

2021 Year 08 Month 25 Day

Anticipated trial start date

2022 Year 01 Month 01 Day

Last follow-up date

2024 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

2022 Year 01 Month 20 Day

Last modified on

2022 Year 03 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053247


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name