Cut-off Values of Muscle Thickness Ratio for Sarcopenia

Cut-off Values and Adjustments for Diagnosing Sarcopenia

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Other: Ultrasonographic evaluation

Detailed Description

Decreases in total skeletal muscle mass are accepted to be necessary for confirming the diagnosis of sarcopenia. Many methods are also used for the definition of sarcopenia.

However, ultrasound measurements has a high sensitivity and specify for confirming the diagnosis 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.

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Ozden Ozkal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group:young; Sixty older subjects will be evaluated in this study.	Other: Ultrasonographic evaluation; Ultrasonographic measurement is assessment method to diagnosis of sarcopenia
Active Comparator: Control Group:Middle-aged; Sixty middle-aged subjects will be evaluated in this study.	Other: Ultrasonographic evaluation; Ultrasonographic measurement is assessment method to diagnosis of sarcopenia
Experimental: Experimental group:older; Sixty older subjects will be evaluated in this study.	Other: Ultrasonographic evaluation; Ultrasonographic measurement is assessment method to diagnosis of sarcopenia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Muscle strength will be evaluated using an isokinetic dynamometer (Biodex Medical Systems, New York, USA). Knee and ankle muscle strength( flexion, extension, dorsiflexion and plantarflexion) will be evaluated. The unit of measure is Nm/kg.	15 minutes
Peripheral strength	The peripheral (handgrip) strength will be measured with a dynamometer (JAMAR).Three measurements will be taken, whose average of the three measurements will be collected. The unit of measure is kg.	1 minutes
Physical function	Physical function will be evaluated by short physical performance scale. The score of this scale range from 0 (worst performance) to 12 (best performance).	5 minutes
Anthropometric assessments	Participants waist, hip and calf circumferences will be measured by tape measure. The unit of measure is centimeters.	5 minutes
Balance	Timed up and go test evaluates dynamic balance of participants. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair.Timed up and go test measure is second. The lower values indicates the better balance.	1 minute
Body mass index	Participants' weight and height will be evaluated by electronic weighing and tape measure, respectively. body mass index will be expressed in in kg/ m²	1 minute

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): August 9, 2019

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: ultrasound; muscle; older people
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: GO 18/506-39

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