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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046684
Receipt No. 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

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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
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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