- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03579329
Effect of Total Knee Arthroplasty on Sarcopenia in Patients With Osteoarthritis in the Knee (Sarcopenia)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Notably, sarcopenia often accompanies with osteoarthritis (OA). However, the relationship between sarcopenia and OA is still unclear. One understanding is that sarcopenia and OA and co-existing conditions. One study identified sarcopenia as one of the risk factors of OA. There is also a study which speculated that OA may inhibit the progression of sarcopenia since they observed OA patients had higher BMP4-positive tissues, which indicated presence of satellites cells that may increase muscle regeneration capabilities.
However, more studies suggested that OA may contribute to the development of sarcopenia among the elderly. First, it is observed that the prevalence of sarcopenia among OA patients is higher than among the normal population. Further, cross-sectional studies demonstrated that hip or knee OA are associated with declines in muscle mass and muscle strength. Most interestingly, female patients with knee OA had declined lean body mass in their lower limbs, but not in their upper limbs or trunks.
Major risk factors of sarcopenia include malnutrition and lack of physical exercise. Therefore, diet supplementation and exercise potentially provide means to alleviate sarcopenia. Studies have demonstrated that strength training in the elderly can improve sarcopenia by increasing muscle strength, mass, power and quality. Exercise habit in middle age could prevent sarcopenia in elder age, maintaining better scores in grip strength, gait speed, and one-leg standing time. Possible molecular mechanism of exercise on sarcopenia is the upregulated nuclear factor-erythroid 2 p45-related factor 2 (Nrf2)-mediated antioxidant response cascade in skeletal muscle, which protected the muscle from oxygen species-mediated toxicity.
OA patients often adopt a sedentary life style to avoid joint pain and stiffness, which probably triggers the dysfunction of Nrf2 -mediated antioxidant response cascade, eventually leading to skeletal muscle atrophy. With the ultimate solution, total knee anthroplasty (TKA), patients with knee OA gradually regain their mobility and greatly increase their social and physical activities. Therefore, one can expect to see improved sarcopenia in patients with knee OA after TKA.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and Female aged over 18 wirh end stage knee OA
- Scheduled for TKA
- Agree to provide written consent
Exclusion Criteria:
- History of alcoholism or drug abuse
- Pregnancy and breast-feeding
- Presence of serious pathologies
- Steroid-based systemic therapy in progress or interrupted since less than 1 month
- With significant hematologic diseases
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Physical Activity Questionnaire (IPAQ)
Time Frame: one year
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Questionnaire
|
one year
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DXA scan
Time Frame: one year
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Lean Muscle Mass Index
|
one year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: one year
|
Questionnaire
|
one year
|
Self-Rated 12
Time Frame: one year
|
Questionnaire
|
one year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015.539
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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