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Completed

NCT Number: NCT03832608

Sarcopenia Cut-points and Functionality in Older Adults

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.

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Key information

Conditions

Sarcopenia Atrophy Diagnostic Disease Frailty Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Armonea Group

Valencia, 46015, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No intervention

Other

There is not intervention to be administered, only collection of data through various tests and questionnaires.

Primary outcomes

  1. First criteria of sarcopenia diagnostic: hand grip strength

    Time frame: 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).

  2. First criteria of sarcopenia diagnostic: knew extension strength

    Time frame: 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).

  3. First criteria of sarcopenia diagnostic: elbow flexion strength

    Time frame: 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).

  4. Second criteria of sarcopenia diagnostic: muscle mass

    Time frame: 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).

  5. Third criteria of sarcopenia diagnostic: walk speed

    Time frame: 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.

Secondary outcomes

  1. Functionality: Modified Baecke Questionnaire

    Time frame: 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.

  2. Functionality: Barthel Index

    Time frame: 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.

  3. Functionality: Lawton and Brody Questionnaire

    Time frame: 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.

  4. Frailty: Fried Scale

    Time frame: 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.

  5. Frailty:Frail Scale

    Time frame: 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.

  6. Frailty: Kihon Check List (KCL)

    Time frame: 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.

  7. Comorbidity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Relationship Between the Sarcopenia Diagnostic Cut-points and Functionality in Older Adults

Acronym: SARCOFUNC

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2019
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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