NCT03993405

Brief 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. Therefore, the aim of this study is to determine the cut-off values of this ratio for confirming the diagnosis of sarcopenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2019

Completed
Last Updated

August 13, 2019

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

June 18, 2019

Last Update Submit

August 10, 2019

Conditions

Sarcopenia

Keywords

older peoplemuscleultrasound

Outcome Measures

Primary Outcomes (2)

  • Muscle thickness

    Muscle thickness in millimeters by Ultrasound.

    30 minutes

  • Skeletal muscle mass

    Skeletal muscle mass will be evaluated by bioelectrical impedance analysis.The unit of measure is kg.

    2 minutes

Secondary Outcomes (6)

  • Muscle strength

    15 minutes

  • Peripheral strength

    1 minutes

  • Physical function

    5 minutes

  • Anthropometric assessments

    5 minutes

  • Balance

    1 minute

  • +1 more secondary outcomes

Study Arms (3)

Control group:young

ACTIVE COMPARATOR

Sixty older subjects will be evaluated in this study.

Other: Ultrasonographic evaluation

Control Group:Middle-aged

ACTIVE COMPARATOR

Sixty middle-aged subjects will be evaluated in this study.

Other: Ultrasonographic evaluation

Experimental group:older

EXPERIMENTAL

Sixty older subjects will be evaluated in this study.

Other: Ultrasonographic evaluation

Interventions

Ultrasonographic evaluationOTHER

Ultrasonographic measurement is assessment method to diagnosis of sarcopenia

Control Group:Middle-agedControl group:youngExperimental group:older

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be a volunteer to participate
  • To be an aged 18-90 years old.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozden Ozkal

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 20, 2019

Study Start

January 1, 2019

Primary Completion

July 30, 2019

Study Completion

August 9, 2019

Last Updated

August 13, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)