SarcopeniaNCT04960007
Comparison of the Swallowing Functions in Sarcopenia and Dynapenia
An observational study of Sarcopenia and Dysphagia, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study to investigate the comparison of the swallowing functions of the sarcopenia and dynapenia in older patients Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Dysphagia, Swallowing Disorder
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jul 2021to 27 Aug 2021
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who were 60-90 years old.
Who may be able to join
- Age between 60-90 years
- Sarcopenia and dynapenia patients in study groups
- Non- sarcopenia and non-dynapenia patients in control groups
- Patients who were accept to consent form
Who cannot join
- Severe sarcopenia patients
- Cognitive limitations
- Out of age 60-90 years old
- Patients who were not accept to consent form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof Dr Cemil Tascioglu City Hospital
Istanbul, 34384
About this study
Official title: Comparison of the Swallowing Functions of the Sarcopenia and Dynapenia Patients
The purpose of the study to investigate the comparison of the swallowing functions of the sarcopenia and dynapenia in older patients
Read the detailed description
Sarcopenia is a geriatric syndrome; from skeletal muscle, and in its usefulness. Dynapenia is a picture of sarcopenia without measurable muscle mass. It has been shown that dysphagia complaints are more common in patients with sarcopenia than in the normal population, but a comparison with patients with dynapenia has not been made to the best of our knowledge. According to the algorithm of The International Society of Physical and Rehabilitation Medicine (ISPRM), experts in the special interest group on sarcopenia, in the routine examination of patients aged 60-90 years who applied to the Physical Medicine and Rehabilitation outpatient clinic with complaints of decreased muscle function, weakness, and slow movement, or "sarcopenia" or Patients with "dynapenia" and patients without Sarcopenia disease who volunteered to participate in the study will be included in the order of application to the outpatient clinic.
- Conditions
- Sarcopenia, Dysphagia, Swallowing Disorder
- Keywords
- sarcopenia, dynapenia, swallowing, deglutition, dysphagia
- Medical subject headings
- Sarcopenia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Sarcopenia patients. | |
| Group B | Dynapenia patients. | |
| Group C | Age and gender matched non-sarcopenia and non-dynapenia patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The values of Pharyngeal Residue Severity
It was assessed with Fiberoptic Endoscopic Evaluation of Swallowing. Fiberoptic Endoscopic Evaluation of Swallowing results were scored on Yale Pharyngeal Residue Severity Rating scale. The scores of scale were none, trace, mild, moderate, and severe. The high-grade symptom scores were worst, low scores were good swallowing functions.
Measured: Baseline
The values of penetration and aspiration
It was assessed with Fiberoptic Endoscopic Evaluation of Swallowing. Fiberoptic Endoscopic Evaluation of Swallowing results were scored on the Penetration and aspiration scale. The scores of scale were between 1-8 points. The high points were worst, low points were good swallowing functions.
Measured: Baseline
The evaluation of eating and swallowing functions
They were assessed by Eating Assessment Tool in participants. Composite Score ranges from 0 ( good) to 4 (worst). The minimum total score was 0 and the maximum total score was 40. The cut-off value was 3 points. High scores show worst eating and swallowing functions, and low quality of life.
Measured: Baseline
The evaluation of depression
They were assessed by Geriatric Depression Scale in participants. The scores between 0-10 were no depression, between 11-13 points were probably depression, and higher of 14 points were exact depression.
Measured: Baseline
The values of muscle strength
They were assessed as newton by hand grip device.
Measured: Baseline
The values of muscle mass
The diameters of tigh were measured with tailor meter by a Physical Medicine and Rehabilitation professionals (measure unit is cm).
Measured: Baseline
Secondary outcomes (1)
Mean of demographic
Age, gender, history of smoke, history of morbidities, diagnosis, stage, were noted
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start26 Jul 2021
- Primary completion27 Aug 2021 (estimated)
- Study completion27 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- yavuz atar, Asso Prof,MD, Principal investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960007
- Sponsor's protocol ID
- 261
- Status last verified
- Aug 2021
- First submitted
- 2 Jul 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Firat Ozer F, Akin S, Soysal T, Gokcekuyu BM, Erturk Zararsiz G. Relationship Between Dysphagia and Sarcopenia with Comprehensive Geriatric Evaluation. Dysphagia. 2021 Feb;36(1):140-146. doi: 10.1007/s00455-020-10120-3. Epub 2020 Apr 27.
PubMed 32342177Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.
PubMed 34121127Chen YC, Chen PY, Wang YC, Wang TG, Han DS. Decreased swallowing function in the sarcopenic elderly without clinical dysphagia: a cross-sectional study. BMC Geriatr. 2020 Oct 21;20(1):419. doi: 10.1186/s12877-020-01832-0.
PubMed 33087067
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Swallowing Functions of the Sarcopenia and Dynapenia Patients
- ClinicalTrials.gov ID
- NCT04960007
- Acronym / sponsor ID
- 261
- Conditions
- Sarcopenia, Dysphagia, Swallowing Disorder
- Keywords
- sarcopenia, dynapenia, swallowing, deglutition, dysphagia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 27 Aug 2021 (estimated)
- Study completion
- 27 Aug 2021 (estimated)
- First posted
- 13 Jul 2021 (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 purpose of the study to investigate the comparison of the swallowing functions of the sarcopenia and dynapenia in older patients
Detailed description
Sarcopenia is a geriatric syndrome; from skeletal muscle, and in its usefulness. Dynapenia is a picture of sarcopenia without measurable muscle mass. It has been shown that dysphagia complaints are more common in patients with sarcopenia than in the normal population, but a comparison with patients with dynapenia has not been made to the best of our knowledge. According to the algorithm of The International Society of Physical and Rehabilitation Medicine (ISPRM), experts in the special interest group on sarcopenia, in the routine examination of patients aged 60-90 years who applied to the Physical Medicine and Rehabilitation outpatient clinic with complaints of decreased muscle function, weakness, and slow movement, or "sarcopenia" or Patients with "dynapenia" and patients without Sarcopenia disease who volunteered to participate in the study will be included in the order of application to the outpatient clinic.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Sarcopenia patients. |
| Group B | – | –Dynapenia patients. |
| Group C | – | –Age and gender matched non-sarcopenia and non-dynapenia patients. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were 60-90 years old.
Key inclusion criteria (4 listed)
- Age between 60-90 years
- Sarcopenia and dynapenia patients in study groups
- Non- sarcopenia and non-dynapenia patients in control groups
- Patients who were accept to consent form
Key exclusion criteria (4 listed)
- Severe sarcopenia patients
- Cognitive limitations
- Out of age 60-90 years old
- Patients who were not accept to consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The values of Pharyngeal Residue Severity
Time frame: Baseline
It was assessed with Fiberoptic Endoscopic Evaluation of Swallowing. Fiberoptic Endoscopic Evaluation of Swallowing results were scored on Yale Pharyngeal Residue Severity Rating scale. The scores of scale were none, trace, mild, moderate, and severe. The high-grade symptom scores were worst, low scores were good swallowing functions.
The values of penetration and aspiration
Time frame: Baseline
It was assessed with Fiberoptic Endoscopic Evaluation of Swallowing. Fiberoptic Endoscopic Evaluation of Swallowing results were scored on the Penetration and aspiration scale. The scores of scale were between 1-8 points. The high points were worst, low points were good swallowing functions.
The evaluation of eating and swallowing functions
Time frame: Baseline
They were assessed by Eating Assessment Tool in participants. Composite Score ranges from 0 ( good) to 4 (worst). The minimum total score was 0 and the maximum total score was 40. The cut-off value was 3 points. High scores show worst eating and swallowing functions, and low quality of life.
The evaluation of depression
Time frame: Baseline
They were assessed by Geriatric Depression Scale in participants. The scores between 0-10 were no depression, between 11-13 points were probably depression, and higher of 14 points were exact depression.
The values of muscle strength
Time frame: Baseline
They were assessed as newton by hand grip device.
The values of muscle mass
Time frame: Baseline
The diameters of tigh were measured with tailor meter by a Physical Medicine and Rehabilitation professionals (measure unit is cm).
1 secondary outcome
Mean of demographic
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Background: PubMed 32342177Firat Ozer F, Akin S, Soysal T, Gokcekuyu BM, Erturk Zararsiz G. Relationship Between Dysphagia and Sarcopenia with Comprehensive Geriatric Evaluation. Dysphagia. 2021 Feb;36(1):140-146. doi: 10.1007/s00455-020-10120-3. Epub 2020 Apr 27.
- Background: PubMed 34121127Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.
- Background: PubMed 33087067Chen YC, Chen PY, Wang YC, Wang TG, Han DS. Decreased swallowing function in the sarcopenic elderly without clinical dysphagia: a cross-sectional study. BMC Geriatr. 2020 Oct 21;20(1):419. doi: 10.1186/s12877-020-01832-0.
- 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.
yavuz atar, Asso Prof,MD principal investigator
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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 Dysphagia, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 4 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: status not confirmed, as of the sponsor's last update on 25 Aug 2021. 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?
Results are not available in the source record.
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?
The values of Pharyngeal Residue Severity (time frame: Baseline). The study lists 6 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 NCT04960007, which also lists 3 linked publications.
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 25 Aug 2021.