Unique ID issued by UMIN | UMIN000046684 |
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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 |
Effect of upper limb cycling exercise in combination with standard physical therapy after total knee arthroplasty on prevention of chronic pain.
Effect of upper limb cycling exercise on prevention of chronic pain after total knee arthroplasty.
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.
Effect of aerobic exercise using an upper limb ergometer after total knee arthroplasty on prevention of chronic post-surgical pain.
Japan |
Patients with knee osteoarthritis scheduled for primary, unilateral total knee arthroplasty.
Orthopedics | Rehabilitation medicine |
Others
NO
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.
Efficacy
Incidence of chronic post-surgical pain at 6 months after surgery (Visual analog scale; VAS>30mm).
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Maneuver |
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).
Standard postoperative physical therapy.
18 | years-old | <= |
Not applicable |
Male and Female
Patients diagnosed with knee osteoarthritis scheduled for primary, unilateral total knee arthroplasty at the research institute.
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.
80
1st name | Junya |
Middle name | |
Last name | Sakamoto |
Nagasaki University Graduate School of Biomedical Sciences
Department of Physical Therapy Science, Medical and Dental Sciences
852-8520
1-7-1 Sakamoto, Nagasaki, Japan
095-819-7964
jun-saka@nagasaki-u.ac.jp
1st name | Junya |
Middle name | |
Last name | Sakamoto |
Nagasaki University Graduate School of Biomedical Sciences
Department of Physical Therapy Science, Medical and Dental Sciences
852-8520
1-7-1 Sakamoto, Nagasaki, Japan
095-819-7964
jun-saka@nagasaki-u.ac.jp
Nagasaki University Graduate School of Biomedical Sciences
None
Self funding
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki University Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee
1-7-1 Sakamoto, Nagasaki, Japan
095-819-7198
hirano@nagasaki-u.ac.jp
NO
日本赤十字社 長崎原爆病院(長崎県)
Japanese Red Cross Nagasaki Genbaku Hospital
2022 | Year | 01 | Month | 20 | Day |
Unpublished
Open public recruiting
2021 | Year | 07 | Month | 19 | Day |
2021 | Year | 08 | Month | 25 | Day |
2022 | Year | 01 | Month | 01 | Day |
2024 | Year | 03 | Month | 31 | Day |
2022 | Year | 01 | Month | 20 | Day |
2022 | Year | 03 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053247
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