SarcopeniaNCT04451005
Diagnostic Evaluation of Sarcopenia in Elderly Patients
An observational study of Sarcopenia, run by University of Sao Paulo.
Trial summary
Sarcopenia is a generalized progressive skeletal muscle disorder that represents a related physiological vulnerability that is associated with or increases the likelihood of adverse outcomes, including falls, fractures, physical disability and death. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- 0
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2016to 10 Dec 2019
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly patients over 60 years old, with cognitive ability and interested in participating in the study
Who may be able to join
- Age ≥ 60 years
- Sign free and informed consent;
- Demonstrate interest, conditions and availability to participate in all procedures included in the study protocol;
Who cannot join
- Refusal to participate;
- Patients who have not undergone cognitive testing;
- Physical amputation;
- Patients undergoing interventional treatment for sarcopenia;
About this study
Official title: Development of a New Sarcopenia Screening Tool in the Elderly
Sarcopenia is a generalized progressive skeletal muscle disorder that represents a related physiological vulnerability that is associated with or increases the likelihood of adverse outcomes, including falls, fractures, physical disability and death. The parameters used to assess sarcopenia in clinical practice have limited use due to their custody.
In this perspective, this study proposes or develops a tool for the diagnosis of having sarcopenia with a specific boa and a sensitive boa.
Read more
low cost and useful.
Elderly patients (n = 403) from the Geriatrics Outpatient Clinic of Hospital das Clínicas, Faculty of Medicine, University of São Paulo will be selected
This study was of clinical importance, due to sarcopenia and a relevant factor, and could lead to consequences and poor prognosis in patients with gold, and it was not a method of clinical practice to properly endorse body composition in this population.
Read the detailed description
Sarcopenia is a progressive and generalized skeletal muscle disorder that represents an age-related physiological vulnerability that is associated with an increased likelihood of adverse outcomes, including falls, fractures, physical disability and mortality. The parameters used to assess sarcopenia in clinical practice have limited use due to its cost.
In this perspective, this study proposes the development of a tool for the diagnosis of having sarcopenia with good specificity and good sensitivity and of low cost and useful.
Elderly patients (n = 403) from the Geriatrics Outpatient Clinic of Hospital das Clínicas, Faculty of Medicine, University of São Paulo will be selected. After signing the informed consent, sarcopenia will be assessed using the reference method (DXA) and anthropometry. The data obtained by the methods are treated statistically to obtain correlation and thus a new tool for the evaluation of sarcopenia patients in the elderly can be developed.
This study is of clinical importance, as sarcopenia is a relevant factor and can lead to consequences and poor prognosis in elderly patients, and there is no low-cost method in clinical practice to properly assess body composition in this population.
- Conditions
- Sarcopenia
- Being tested
- 0
- Keywords
- Body composition, Sarcopenia, Elderly
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0Other
Elderly patients with sarcopenia
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients with sarcopenia | Elderly patients with sarcopenia Receives: Other: 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sarcopenia in the elderly
Evaluation of sarcopenia in the elderly
Measured: 12 months
Secondary outcomes (1)
Development of a new tool for sarcopenia screening
Development of a new tool for sarcopenia screening
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start6 May 2016
- Primary completion6 May 2018
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Linetzky Waitzberg, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451005
- Sponsor's protocol ID
- SARC-F
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Sarcopenia Screening Tool in the Elderly
- ClinicalTrials.gov ID
- NCT04451005
- Acronym / sponsor ID
- SARC-F
- Conditions
- Sarcopenia
- Keywords
- Body composition, Sarcopenia, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 6 May 2016 (actual)
- Primary completion
- 6 May 2018 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 30 Jun 2020 (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 generalized progressive skeletal muscle disorder that represents a related physiological vulnerability that is associated with or increases the likelihood of adverse outcomes, including falls, fractures, physical disability and death. The parameters used to assess sarcopenia in clinical practice have limited use due to their custody.
In this perspective, this study proposes or develops a tool for the diagnosis of having sarcopenia with a specific boa and a sensitive boa.
low cost and useful.
Elderly patients (n = 403) from the Geriatrics Outpatient Clinic of Hospital das Clínicas, Faculty of Medicine, University of São Paulo will be selected
This study was of clinical importance, due to sarcopenia and a relevant factor, and could lead to consequences and poor prognosis in patients with gold, and it was not a method of clinical practice to properly endorse body composition in this population.
Detailed description
Sarcopenia is a progressive and generalized skeletal muscle disorder that represents an age-related physiological vulnerability that is associated with an increased likelihood of adverse outcomes, including falls, fractures, physical disability and mortality. The parameters used to assess sarcopenia in clinical practice have limited use due to its cost.
In this perspective, this study proposes the development of a tool for the diagnosis of having sarcopenia with good specificity and good sensitivity and of low cost and useful.
Elderly patients (n = 403) from the Geriatrics Outpatient Clinic of Hospital das Clínicas, Faculty of Medicine, University of São Paulo will be selected. After signing the informed consent, sarcopenia will be assessed using the reference method (DXA) and anthropometry. The data obtained by the methods are treated statistically to obtain correlation and thus a new tool for the evaluation of sarcopenia patients in the elderly can be developed.
This study is of clinical importance, as sarcopenia is a relevant factor and can lead to consequences and poor prognosis in elderly patients, and there is no low-cost method in clinical practice to properly assess body composition in this population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients with sarcopenia | – | Other: 0Elderly patients with sarcopenia |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients over 60 years old, with cognitive ability and interested in participating in the study
Key inclusion criteria (3 listed)
- Age ≥ 60 years
- Sign free and informed consent;
- Demonstrate interest, conditions and availability to participate in all procedures included in the study protocol;
Key exclusion criteria (4 listed)
- Refusal to participate;
- Patients who have not undergone cognitive testing;
- Physical amputation;
- Patients undergoing interventional treatment for sarcopenia;
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 |
|---|---|---|
| 0Elderly patients with sarcopenia | Other | Elderly patients with sarcopenia |
Primary outcome
Sarcopenia in the elderly
Time frame: 12 months
Evaluation of sarcopenia in the elderly
1 secondary outcome
Development of a new tool for sarcopenia screening
Time frame: 12 months
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 30 Jun 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by University of Sao Paulo.
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 4 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 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Sarcopenia in the elderly (time frame: 12 months). 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 30 Jun 2020.