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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03579329
Other study ID # 2015.539
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2020
Est. completion date February 2, 2022

Study information

Verified date March 2022
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sarcopenia is a wasting disease with the locomotion system in the aged population. It is defined as the decline in muscle mass (lean body mass) and strength with the advance of age. The prevalence of sarcopenia increases with age, reaching an astounding 50% among the population aged over 75 in the United States. Sarcopenia is often associated with frailty, falls, and disability. Studies have found sarcopenia can be a predicting risk factor for fractures in the elderly. In addition, sarcopenia predicted a higher chance of mortality in nursing homes.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date February 2, 2022
Est. primary completion date February 2, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Total Knee Arthroplasty
Effect of Total Knee Arthroplasty on Sarcopenia in Patients with Osteoarthritis in the Knee

Locations

Country Name City State
Hong Kong Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary International Physical Activity Questionnaire (IPAQ) Questionnaire one year
Primary DXA scan Lean Muscle Mass Index one year
Secondary Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire one year
Secondary Self-Rated 12 Questionnaire one year
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