Sarcopenia Cut-points and Functionality in Older Adults

Completed

• Conditions: Diagnostic; Sarcopenia
• Interventions: Other: No intervention

• Registration Number: NCT03832608
• Lead Sponsor: University of Valencia

Brief Summary

This is a cross-sectional study conducted in older adults living in Valencia Province in order to establish the cut-off points of the multicriteria diagnostic of sarcopenia through functionality and frailty variables.

Detailed Description

Sarcopenia is a geriatric syndrome that involves a gradual and generalized loss of the mass and strength of the skeletal muscles. Currently, there is an international debate about the criteria and reference values for the sarcopenia diagnosis, and the main scientific societies encourage improving research on this. The biggest problem lies in the assessment of the diagnostic criterion of muscle mass while the criterion of muscular strength seems safer and more robust. Experts point out the need to adjust the muscle mass indexes to the characteristics of the population studied, and the convenience of relating the three diagnostic criteria of sarcopenia (muscle mass and strength, and walking speed) with other variables that report about functionality and frailty in older adults.

The main objective is to establish different cut-off points for the diagnostic criteria of sarcopenia and relate them with other instruments for assessing functionality in older population of Valencia Province.

To this purpose, data will be collected through various tests and questionnaires about: clinical, demographic and anthropometric characteristics; muscle mass; muscle strength; walk speed; physical and cognitive function; nutritional status; self-perception of health; comorbidity and frailty. With this information it will be possible, as primary outcome, to determine a more sensitive, reliable and valid muscle mass index to predict sarcopenia, and, as a secondary outcome, to establish the relationship between the multicriteria diagnostic of sarcopenia with the functional and frailty variables.

Study Timeline

• Study Start: 2019-01-08
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• People aged > 65 years
• Residents in Valencia Province (Living-Community, Day-Centers and institutionalized)

Exclusion Criteria

• Lobo Mini-exam cognoscitive < 18 score
• Any disorder that prevents from performing the assessment tests.
• Recent hospitalization or who are in a acute process of any illness (less one month).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Older adults and Sarcopenia	No intervention	Older adults with and without Sarcopenia living in Valencia Province.

Primary Outcome Measures

Name	Time	Method
First criteria of sarcopenia diagnostic: elbow flexion strength	The cohort group will be assessed in one day visit.	Muscle strength measured by the isometric elbow flexion (reference: Phys Ther. 1996;76(3):248-59).
Third criteria of sarcopenia diagnostic: walk speed	The cohort group will be assessed in one day visit.	Walk speed measured by the Short Physical Performance Balance test (SPPB) (reference: J Gerontol A Biol Sci Med Sc 2000; 55(4):M221-31.
First criteria of sarcopenia diagnostic: knew extension strength	The cohort group will be assessed in one day visit.	Muscle strength measured by the isometric knew extension (reference: Phys Ther. 1996;76(3):248-59).
First criteria of sarcopenia diagnostic: hand grip strength	The cohort group will be assessed in one day visit.	Muscle strength measured by the isometric hand grip strength (reference: Age and Aging. 2010;39:412-23).
Second criteria of sarcopenia diagnostic: muscle mass	The cohort group will be assessed in one day visit.	Muscle mass estimated by Bioimpedance analysis (BIA) (reference: J Aging Phys Act. 2015;23(4):597-606).

Secondary Outcome Measures

Name	Time	Method
Functionality: Modified Baecke Questionnaire	The cohort group will be assessed in one day visit.	Functionality measured by the Modified Baecke Questionnaire (reference: Med Clin.2007;129:326-32). The Modified Baecke Questionnaire results in a score to classify people as high, moderate, or low in daily physical activity, based on tertiles.; Work Index = 0 1 +12 + 13 + 14 + 15 + 16 + 17 + I8)/8 Sport Index = 0 9 + 110 + II1 + I12)/4 Leisure Time Index = 0 ' 3 + 114 + 115 + 116 + 117 + 118 + I19V7 Total Index = work index + sports index + leisure time index.
Comorbidity	The cohort group will be assessed in one day visit.	Comorbidity measured by Abbreviated Charslon Index (reference: J Chron Dis.1987;40:373-83). Range from 0 to 10 score. High score of 10 means high comorbidity; 0 means absence of comorbidity.
Functionality: Barthel Index	The cohort group will be assessed in one day visit.	Functionality measured by the Barthel Index (reference: Rev Esp Geriatr Gerontol.1993;28:32-40). Range from 0 to 100 score. High score of 100 means total independent.
Frailty: Fried Scale	The cohort group will be assessed in one day visit.	Frailty measured by the Fried Scale (reference: J Gerontol A Biol Sci Med Sc. 2001;56(3):M146-56). It is a scale with 5 domains: weight loss, self-reported exhaustion, physical activity, walking speed, and weakness. It has a total score ≥ 5 points. A frail person is who scores 3 to 5; is prefrail when scores is 1 to 2, and robust if scores is 0.
Functionality: Lawton and Brody Questionnaire	The cohort group will be assessed in one day visit.	Functionality measured by the Lawton and Brody Questionnaire (reference: Gerontologist.1969;9:179-86).Range from 0 to 8 score. High score of 8 means total independent to perform daily activities.
Frailty:Frail Scale	The cohort group will be assessed in one day visit.	Frailty measured by the Frail Scale (reference: J Nutr Health Aging. 2012;16(7):601-8). It has a total score of 5 points. The more score the more frailty. As in Fried scale, participants with scores 3 to 5 is frail person; with scores 1 to 2 is prefrail, and robust if scores is 0.
Frailty: Kihon Check List (KCL)	The cohort group will be assessed in one day visit.	Frailty measured by the Kihon Check List (reference: Geriatr Gerontol Int. 2016;16(6):709-15). The KCL is a simple self-reporting yes/no survey consisting of 25 questions structured into seven domains /dimensions. A total score ≥ 10 points allow to identify a frail person and each domain can identify the specific need.

Trial Locations

Locations (1)

Armonea Group; 🇪🇸 Valencia, Spain