- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04960007
Comparison of the Swallowing Functions in Sarcopenia and Dynapenia
August 21, 2021 updated by: Sevgi Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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
Study Overview
Status
Active, not recruiting
Conditions
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 Type
Observational
Enrollment (Actual)
108
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34384
- Prof Dr Cemil Tascioglu City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
56 years to 86 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who were 60-90 years old.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Severe sarcopenia patients
- Cognitive limitations
- Out of age 60-90 years old
- Patients who were not accept to consent form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Group A
Sarcopenia patients.
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Group B
Dynapenia patients.
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Group C
Age and gender matched non-sarcopenia and non-dynapenia patients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The values of Pharyngeal Residue Severity
Time Frame: Baseline
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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.
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Baseline
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The values of penetration and aspiration
Time Frame: Baseline
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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.
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Baseline
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The evaluation of eating and swallowing functions
Time Frame: Baseline
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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.
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Baseline
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The evaluation of depression
Time Frame: Baseline
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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.
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Baseline
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The values of muscle strength
Time Frame: Baseline
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They were assessed as newton by hand grip device.
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Baseline
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The values of muscle mass
Time Frame: Baseline
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The diameters of tigh were measured with tailor meter by a Physical Medicine and Rehabilitation professionals (measure unit is cm).
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean of demographic
Time Frame: Baseline
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Age, gender, history of smoke, history of morbidities, diagnosis, stage, were noted
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: yavuz atar, Asso Prof,MD, Prof. Dr. Cemil Taşcıoğlu City Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Kara 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.
- Chen 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 26, 2021
Primary Completion (Anticipated)
August 27, 2021
Study Completion (Anticipated)
August 27, 2021
Study Registration Dates
First Submitted
July 2, 2021
First Submitted That Met QC Criteria
July 2, 2021
First Posted (Actual)
July 13, 2021
Study Record Updates
Last Update Posted (Actual)
August 25, 2021
Last Update Submitted That Met QC Criteria
August 21, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 261
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.