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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Patients with knee osteoarthritis scheduled for primary, unilateral total knee arthroplasty. | ||
Classification by specialty |
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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 |
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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. | |
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Eligibility | ||||
Age-lower limit |
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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 |
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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 |
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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 | |
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 |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Recruitment status | Open public recruiting | ||||||
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Last modified on |
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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 | |
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Research case data | |
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