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 | 2025/02/03 18:44:29 |
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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
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
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
gakujutu_gakuji@ml.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
| 2026 | 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
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053247
