SarcopeniaNCT03993405
Cut-off Values of Muscle Thickness Ratio for Sarcopenia
A study testing Ultrasonographic evaluation in people with Sarcopenia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The loss of muscle mass is one of the major diagnostic criteria for sarcopenia. Many methods are also used for the definition of sarcopenia. However there is no information about cut-off values in this respect in the literature. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Ultrasonographic evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 9 Aug 2019
- Phase
- Interventional
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be a volunteer to participate
- To be an aged 18-90 years old.
Who cannot join
- Walking with assist device
- Having a visual deficits
- Having an undergone orthopedic surgery
- Having a cardiac pacemaker
- Having a hypothyroidism, diabetes mellitus, renal/hepatic failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cut-off Values and Adjustments for Diagnosing Sarcopenia
The loss of muscle mass is one of the major diagnostic criteria for sarcopenia. Many methods are also used for the definition of sarcopenia. However there is no information about cut-off values in this respect in the literature. Therefore, the aim of this study is to determine the cut-off values of this ratio for confirming the diagnosis of sarcopenia.
Read the detailed description
Decreases in total skeletal muscle mass are accepted to be necessary for confirming the diagnosis of sarcopenia. Many methods are also used for the definition of sarcopenia.
However, ultrasound measurements has a high sensitivity and specify for confirming the diagnosis of sarcopenia. However there is no information about cut-off values in this respect in the literature. Therefore, the aim of this study is to determine the cut-off values of this ratio for confirming the diagnosis of sarcopenia.
- Conditions
- Sarcopenia
- Being tested
- Ultrasonographic evaluation
- Keywords
- older people, muscle, ultrasound
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic evaluationOther
Ultrasonographic measurement is assessment method to diagnosis of sarcopenia
| Study group | Role | What they receive |
|---|---|---|
| Control group:young | Active comparator | Sixty older subjects will be evaluated in this study. Receives: Other: Ultrasonographic evaluation |
| Control Group:Middle-aged | Active comparator | Sixty middle-aged subjects will be evaluated in this study. Receives: Other: Ultrasonographic evaluation |
| Experimental group:older | Experimental | Sixty older subjects will be evaluated in this study. Receives: Other: Ultrasonographic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness
Muscle thickness in millimeters by Ultrasound.
Measured: 30 minutes
Skeletal muscle mass
Skeletal muscle mass will be evaluated by bioelectrical impedance analysis.The unit of measure is kg.
Measured: 2 minutes
Secondary outcomes (6)
Muscle strength
Muscle strength will be evaluated using an isokinetic dynamometer (Biodex Medical Systems, New York, USA). Knee and ankle muscle strength( flexion, extension, dorsiflexion and plantarflexion) will be evaluated. The unit of measure is Nm/kg.
Measured: 15 minutes
Peripheral strength
The peripheral (handgrip) strength will be measured with a dynamometer (JAMAR).Three measurements will be taken, whose average of the three measurements will be collected. The unit of measure is kg.
Measured: 1 minutes
Physical function
Physical function will be evaluated by short physical performance scale. The score of this scale range from 0 (worst performance) to 12 (best performance).
Measured: 5 minutes
Anthropometric assessments
Participants waist, hip and calf circumferences will be measured by tape measure. The unit of measure is centimeters.
Measured: 5 minutes
Balance
Timed up and go test evaluates dynamic balance of participants. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair.Timed up and go test measure is second. The lower values indicates the better balance.
Measured: 1 minute
Body mass index
Participants' weight and height will be evaluated by electronic weighing and tape measure, respectively. body mass index will be expressed in in kg/ m²
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Jan 2019
- Primary completion30 Jul 2019
- Study completion9 Aug 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 Hacettepe UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozden Ozkal, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993405
- Sponsor's protocol ID
- GO 18/506-39
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cut-off Values and Adjustments for Diagnosing Sarcopenia
- ClinicalTrials.gov ID
- NCT03993405
- Acronym / sponsor ID
- GO 18/506-39
- Conditions
- Sarcopenia
- Keywords
- older people, muscle, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 20 Jun 2019 (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.
The loss of muscle mass is one of the major diagnostic criteria for sarcopenia. Many methods are also used for the definition of sarcopenia. However there is no information about cut-off values in this respect in the literature. Therefore, the aim of this study is to determine the cut-off values of this ratio for confirming the diagnosis of sarcopenia.
Detailed description
Decreases in total skeletal muscle mass are accepted to be necessary for confirming the diagnosis of sarcopenia. Many methods are also used for the definition of sarcopenia.
However, ultrasound measurements has a high sensitivity and specify for confirming the diagnosis of sarcopenia. However there is no information about cut-off values in this respect in the literature. Therefore, the aim of this study is to determine the cut-off values of this ratio for confirming the diagnosis of sarcopenia.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group:young | Active comparator | Other: Ultrasonographic evaluationSixty older subjects will be evaluated in this study. |
| Control Group:Middle-aged | Active comparator | Other: Ultrasonographic evaluationSixty middle-aged subjects will be evaluated in this study. |
| Experimental group:older | Experimental | Other: Ultrasonographic evaluationSixty older subjects will be evaluated in this study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To be a volunteer to participate
- To be an aged 18-90 years old.
Key exclusion criteria (5 listed)
- Walking with assist device
- Having a visual deficits
- Having an undergone orthopedic surgery
- Having a cardiac pacemaker
- Having a hypothyroidism, diabetes mellitus, renal/hepatic failure
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 |
|---|---|---|
| Ultrasonographic evaluationUltrasonographic measurement is assessment method to diagnosis of sarcopenia | Other | Control Group:Middle-aged, Control group:young, Experimental group:older |
Primary outcome
Muscle thickness
Time frame: 30 minutes
Muscle thickness in millimeters by Ultrasound.
Skeletal muscle mass
Time frame: 2 minutes
Skeletal muscle mass will be evaluated by bioelectrical impedance analysis.The unit of measure is kg.
6 secondary outcomes
Muscle strength
Time frame: 15 minutes
Peripheral strength
Time frame: 1 minutes
Physical function
Time frame: 5 minutes
Anthropometric assessments
Time frame: 5 minutes
Balance
Time frame: 1 minute
Body mass index
Time frame: 1 minute
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 13 Aug 2019.
- Individual participant dataSharing planned: No
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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?
A study testing Ultrasonographic evaluation in people with Sarcopenia, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 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 13 Aug 2019. 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 Turkey (Türkiye). 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?
Muscle thickness (time frame: 30 minutes). 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 13 Aug 2019.