UMIN-CTR Clinical Trial

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
Institute	Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

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
URL(English)	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

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