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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04960007
Other study ID # 261
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 26, 2021
Est. completion date August 27, 2021

Study information

Verified date August 2021
Source Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study to investigate the comparison of the swallowing functions of the sarcopenia and dynapenia in older patients


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 108
Est. completion date August 27, 2021
Est. primary completion date August 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 90 Years
Eligibility 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 Design


Locations

Country Name City State
Turkey Prof Dr Cemil Tascioglu City Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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, Özçakar 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary The values of muscle strength They were assessed as newton by hand grip device. Baseline
Primary 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). Baseline
Secondary Mean of demographic Age, gender, history of smoke, history of morbidities, diagnosis, stage, were noted Baseline
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