FrailtyNCT05935800
The Effect of the COVID-19 Pandemic on Frailty in Liver Transplant Candidates
An observational study of Frailty and Sarcopenia, run by Methodist Health System at 1 site in United States.
Trial summary
Frailty is associated with higher rates of morbidity, mortality, and failure to rescue after major surgical procedures. Sarcopenia is degenerative loss of skeletal muscle mass and strength. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Frailty, Sarcopenia, COVID-19
- What is being tested?
- COVID Patients who Underwent pre-transplant frailty assessment (PFA) at MDMC
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to 19 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age 18 years and older Underwent pre-transplant frailty assessment (PFA) at MDMC 369 liver transplant candidates who underwent pre-transplant frailty assessments at the Liver Institute at Methodist Dallas from April 1, 2018 to February 28, 2022. The study data will be divided into cohorts: pre-COVID and COVID. Specifically, the pre-COVID period will consist of the dates between April 1st, 2018 and March 12, 2020, while the COVID period will consist of the dates between March 13, 2020 and February 28th, 2022.
Who may be able to join
- Age 18 years and older Underwent pre-transplant frailty assessment (PFA) at MDMC
Who cannot join
- Not a patient at Liver Institute at Methodist Dallas
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Frailty is associated with higher rates of morbidity, mortality, and failure to rescue after major surgical procedures. Sarcopenia is degenerative loss of skeletal muscle mass and strength. It is a key component of physical frailty and is associated with poorer post-surgical outcomes due to decreased patient strength and vitality.
Read the detailed description
This study seeks to examine whether the (COVID-19) pandemic, an ongoing global health crisis that was declared a national emergency by the US Federal Government on March 13, 2020, has exacerbated both frailty and sarcopenia in a population of liver transplant candidates.
- Conditions
- Frailty, Sarcopenia, COVID-19
- Being tested
- COVID Patients who Underwent pre-transplant frailty assessment (PFA) at MDMC
- Medical subject headings
- Frailty, Sarcopenia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID Patients who Underwent pre-transplant frailty assessment (PFA) at MDMCBehavioural
This is a single-center, retrospective study that uses de-identified, anonymized patient data. Data from 369 liver transplant candidates who underwent pre-transplant frailty assessments at the Liver Institute at Methodist Dallas from April 1, 2018 to February 28, 2022. The study data will be divided into cohorts: pre-COVID and COVID. Specifically, the pre-COVID period will consist of the dates between April 1st, 2018 and March 12, 2020, while the COVID period will consist of the dates between March 13, 2020 and February 28th, 2022.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia
To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia and frailty in patients undergoing liver transplant evaluation at Methodist Dallas Medical Center
Measured: 2 years
To determine the impact of the COVID-19 pandemic on the incidence of sarcopenia
To determine the impact of the COVID-19 pandemic on the incidence of sarcopenia and frailty in patients undergoing liver transplant evaluation at Methodist Dallas Medical Center
Measured: 2 years
Secondary outcomes (3)
Changes in number of comorbidities between pre- and during/post-pandemic periods
Changes in number of comorbidities between pre- and during/post-pandemic periods
Measured: 1 year
Changes in type of comorbidities between pre- and during/post-pandemic periods
Changes in type of comorbidities between pre- and during/post-pandemic periods
Measured: 1 year
Changes in severity of comorbidities between pre- and during/post-pandemic periods
Changes in severity of comorbidities between pre- and during/post-pandemic periods
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start19 Apr 2022
- Primary completion19 Apr 2027 (estimated)
- Study completion19 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parvez Mantry, MD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935800
- Sponsor's protocol ID
- 012.HEP.2022.D
- Status last verified
- May 2026
- First submitted
- 6 Jul 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the COVID-19 Pandemic on Frailty in Liver Transplant Candidates
- ClinicalTrials.gov ID
- NCT05935800
- Acronym / sponsor ID
- 012.HEP.2022.D
- Conditions
- Frailty, Sarcopenia, COVID-19
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 19 Apr 2027 (estimated)
- Study completion
- 19 Apr 2028 (estimated)
- First posted
- 7 Jul 2023 (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.
Frailty is associated with higher rates of morbidity, mortality, and failure to rescue after major surgical procedures. Sarcopenia is degenerative loss of skeletal muscle mass and strength. It is a key component of physical frailty and is associated with poorer post-surgical outcomes due to decreased patient strength and vitality.
Detailed description
This study seeks to examine whether the (COVID-19) pandemic, an ongoing global health crisis that was declared a national emergency by the US Federal Government on March 13, 2020, has exacerbated both frailty and sarcopenia in a population of liver transplant candidates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age 18 years and older Underwent pre-transplant frailty assessment (PFA) at MDMC 369 liver transplant candidates who underwent pre-transplant frailty assessments at the Liver Institute at Methodist Dallas from April 1, 2018 to February 28, 2022. The study data will be divided into cohorts: pre-COVID and COVID. Specifically, the pre-COVID period will consist of the dates between April 1st, 2018 and March 12, 2020, while the COVID period will consist of the dates between March 13, 2020 and February 28th, 2022.
Key inclusion criteria (1 listed)
- Age 18 years and older Underwent pre-transplant frailty assessment (PFA) at MDMC
Key exclusion criteria (1 listed)
- Not a patient at Liver Institute at Methodist Dallas
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 |
|---|---|---|
| COVID Patients who Underwent pre-transplant frailty assessment (PFA) at MDMCThis is a single-center, retrospective study that uses de-identified, anonymized patient data. Data from 369 liver transplant candidates who underwent pre-transplant frailty assessments at the Liver Institute at Methodist Dallas from April 1, 2018 to February 28, 2022. The study data will be divided into cohorts: pre-COVID and COVID. Specifically, the pre-COVID period will consist of the dates between April 1st, 2018 and March 12, 2020, while the COVID period will consist of the dates between March 13, 2020 and February 28th, 2022. | Behavioural | – |
Primary outcome
To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia
Time frame: 2 years
To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia and frailty in patients undergoing liver transplant evaluation at Methodist Dallas Medical Center
To determine the impact of the COVID-19 pandemic on the incidence of sarcopenia
Time frame: 2 years
To determine the impact of the COVID-19 pandemic on the incidence of sarcopenia and frailty in patients undergoing liver transplant evaluation at Methodist Dallas Medical Center
3 secondary outcomes
Changes in number of comorbidities between pre- and during/post-pandemic periods
Time frame: 1 year
Changes in type of comorbidities between pre- and during/post-pandemic periods
Time frame: 1 year
Changes in severity of comorbidities between pre- and during/post-pandemic periods
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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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.
Parvez Mantry, MD principal investigator
Methodist Health System
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 Frailty and Sarcopenia, run by Methodist Health System at 1 site in United States.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia (time frame: 2 years). 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?
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 10 Jun 2026.