SarcopeniaSarcopeniaNCT03579329
Effect of Total Knee Arthroplasty on Sarcopenia in Patients With Osteoarthritis in the Knee
An observational study of Sarcopenia and Osteoarthritis, Knee, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Osteoarthritis, Knee
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Apr 2020to 2 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End stage knee osteoarthritis
Who may be able to join
- Male and Female aged over 18 wirh end stage knee OA
- Scheduled for TKA
- Agree to provide written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong
Hong Kong
About this study
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.
Read the 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.
- Conditions
- Sarcopenia, Osteoarthritis, Knee
- Being tested
- Total Knee Arthroplasty
- Keywords
- sarcopenia, Osteoarthritis, Total Knee Arthroplasty
- Medical subject headings
- Sarcopenia, Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Effect of Total Knee Arthroplasty on Sarcopenia in Patients with Osteoarthritis in the Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire (IPAQ)
Questionnaire
Measured: one year
DXA scan
Lean Muscle Mass Index
Measured: one year
Secondary outcomes (2)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Questionnaire
Measured: one year
Self-Rated 12
Questionnaire
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start30 Apr 2020
- Primary completion2 Feb 2022
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ho Ki Wai, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579329
- Sponsor's protocol ID
- 2015.539
- Acronym
- Sarcopenia
- Status last verified
- Mar 2022
- First submitted
- 26 Jun 2018
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ho KK, Lau LC, Chau WW, Poon Q, Chung KY, Wong RM. End-stage knee osteoarthritis with and without sarcopenia and the effect of knee arthroplasty - a prospective cohort study. BMC Geriatr. 2021 Jan 4;21(1):2. doi: 10.1186/s12877-020-01929-6.
PubMed 33397330
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Total Knee Arthroplasty on Sarcopenia in Patients With Osteoarthritis in the Knee
- ClinicalTrials.gov ID
- NCT03579329
- Acronym / sponsor ID
- Sarcopenia / 2015.539
- Conditions
- Sarcopenia, Osteoarthritis, Knee
- Keywords
- sarcopenia, Osteoarthritis, Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End stage knee osteoarthritis
Key inclusion criteria (3 listed)
- Male and Female aged over 18 wirh end stage knee OA
- Scheduled for TKA
- Agree to provide written consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee ArthroplastyEffect of Total Knee Arthroplasty on Sarcopenia in Patients with Osteoarthritis in the Knee | Procedure or surgery | – |
Primary outcome
International Physical Activity Questionnaire (IPAQ)
Time frame: one year
Questionnaire
DXA scan
Time frame: one year
Lean Muscle Mass Index
2 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: one year
Self-Rated 12
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 33397330Ho KK, Lau LC, Chau WW, Poon Q, Chung KY, Wong RM. End-stage knee osteoarthritis with and without sarcopenia and the effect of knee arthroplasty - a prospective cohort study. BMC Geriatr. 2021 Jan 4;21(1):2. doi: 10.1186/s12877-020-01929-6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Osteoarthritis, Knee, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire (IPAQ) (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03579329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.