NCT04960007

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

July 26, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

July 2, 2021

Last Update Submit

August 21, 2021

Conditions

Keywords

sarcopeniadynapeniaswallowingdeglutitiondysphagia

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • The values of muscle strength

    They were assessed as newton by hand grip device.

    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).

    Baseline

Secondary Outcomes (1)

  • Mean of demographic

    Baseline

Study Arms (3)

Group A

Sarcopenia patients.

Group B

Dynapenia patients.

Group C

Age and gender matched non-sarcopenia and non-dynapenia patients.

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who were 60-90 years old.

You may qualify if:

  • 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

You may not qualify if:

  • Severe sarcopenia patients
  • Cognitive limitations
  • Out of age 60-90 years old
  • Patients who were not accept to consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof Dr Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 32342177BACKGROUND
  • 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.

    PMID: 34121127BACKGROUND
  • 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.

    PMID: 33087067BACKGROUND

MeSH Terms

Conditions

SarcopeniaDeglutition Disorders

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • yavuz atar, Asso Prof,MD

    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist, MD

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 13, 2021

Study Start

July 26, 2021

Primary Completion

August 27, 2021

Study Completion

August 27, 2021

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations