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Cut-off Values of Muscle Thickness Ratio for Sarcopenia

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasonographic evaluation
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sarcopenia focused on measuring older people, muscle, ultrasound

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ozden Ozkal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Control group:young

Control Group:Middle-aged

Experimental group:older

Arm Description

Sixty older subjects will be evaluated in this study.

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

Sixty older subjects will be evaluated in this study.

Outcomes

Primary Outcome Measures

Muscle thickness
Muscle thickness in millimeters by Ultrasound.
Skeletal muscle mass
Skeletal muscle mass will be evaluated by bioelectrical impedance analysis.The unit of measure is kg.

Secondary Outcome Measures

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.
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.
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).
Anthropometric assessments
Participants waist, hip and calf circumferences will be measured by tape measure. The unit of measure is centimeters.
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.
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

Full Information

First Posted
June 18, 2019
Last Updated
August 10, 2019
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03993405
Brief Title
Cut-off Values of Muscle Thickness Ratio for Sarcopenia
Official Title
Cut-off Values and Adjustments for Diagnosing Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
August 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
older people, muscle, ultrasound

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group:young
Arm Type
Active Comparator
Arm Description
Sixty older subjects will be evaluated in this study.
Arm Title
Control Group:Middle-aged
Arm Type
Active Comparator
Arm Description
Sixty middle-aged subjects will be evaluated in this study.
Arm Title
Experimental group:older
Arm Type
Experimental
Arm Description
Sixty older subjects will be evaluated in this study.
Intervention Type
Other
Intervention Name(s)
Ultrasonographic evaluation
Intervention Description
Ultrasonographic measurement is assessment method to diagnosis of sarcopenia
Primary Outcome Measure Information:
Title
Muscle thickness
Description
Muscle thickness in millimeters by Ultrasound.
Time Frame
30 minutes
Title
Skeletal muscle mass
Description
Skeletal muscle mass will be evaluated by bioelectrical impedance analysis.The unit of measure is kg.
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Muscle strength
Description
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.
Time Frame
15 minutes
Title
Peripheral strength
Description
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.
Time Frame
1 minutes
Title
Physical function
Description
Physical function will be evaluated by short physical performance scale. The score of this scale range from 0 (worst performance) to 12 (best performance).
Time Frame
5 minutes
Title
Anthropometric assessments
Description
Participants waist, hip and calf circumferences will be measured by tape measure. The unit of measure is centimeters.
Time Frame
5 minutes
Title
Balance
Description
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.
Time Frame
1 minute
Title
Body mass index
Description
Participants' weight and height will be evaluated by electronic weighing and tape measure, respectively. body mass index will be expressed in in kg/ m²
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ozden Ozkal
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Cut-off Values of Muscle Thickness Ratio for Sarcopenia

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