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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03993405
Other study ID # GO 18/506-39
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date August 9, 2019

Study information

Verified date June 2019
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 292
Est. completion date August 9, 2019
Est. primary completion date July 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Ultrasonographic evaluation
Ultrasonographic measurement is assessment method to diagnosis of sarcopenia

Locations

Country Name City State
Turkey Ozden Ozkal Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle thickness Muscle thickness in millimeters by Ultrasound. 30 minutes
Primary Skeletal muscle mass Skeletal muscle mass will be evaluated by bioelectrical impedance analysis.The unit of measure is kg. 2 minutes
Secondary 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
Secondary 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
Secondary 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
Secondary Anthropometric assessments Participants waist, hip and calf circumferences will be measured by tape measure. The unit of measure is centimeters. 5 minutes
Secondary 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
Secondary 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
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