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Completed

NCT Number: NCT02903992

SArcopenia Prevalence in Frail Older Adults. SAF Study

The age-associated loss of lean mass is a defining parameter of sarcopenia and may lead to various negative health outcomes such as impairment of physical performance and disability. Furthermore sarcopenia is considered to be one of the main factors in the pathogenesis of the frailty syndrome. However, for clinical use and for treatment and prevention strategies, reliable diagnostic criteria and cutpoints based on clinically relevant thresholds are indispensable.

This topic has recently been addressed by the Foundation for the National Institutes of Health Sarcopenia Project which identified cutpoints for appendicular lean mass (ALM) below which older adults had a higher likelihood of clinically relevant weakness reflected by low grip strength. Moreover, a low ALM-to-body mass index (BMI) ratio (<0.789 men and <0.512 women) was found to be associated with increased likelihood for mobility impairment.

In this context, the aim of this study is to study the prevalence of sarcopenia in a sample of community-dwelling frail and pre-frail older adults.

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Key information

Conditions

Aging Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 70 years and over,
  • Living independently (ADL score ≥ 5/6),
  • Fail or pre-frail according to Fried criteria,
  • Informed written consent,
  • Subjects affiliated to a social security.

Exclusion criteria

  • Robusts patients (no Fried criteria),
  • Other disorders that could interfere with the interpretation of the study (like visual or hearing impairments),
  • Subjects under justice protection,
  • Participation in another study at the same time.

Treatment and study plan

Dual-energy X-ray absorptiometry (DXA)

Radiation

Patients with at least one Fried criteria will have a Dual-energy X-ray absorptiometry (DXA) to measure lean muscle mass adjusted for body mass index. As part of the usual care in the Frailty Clinic patients will also have a clinical examination, a standard biological sample (requiring 15 ml of blood); an evaluation of the cognitive and functional performances, of their medico-economic situation and lifestyle.

Primary outcomes

  1. Sarcopenia Diagnostic with Dual-energy X-ray absorptiometry

    Time frame: one day (participation of subject)

    The primary outcome of SAF study is to assess the prevalence of sarcopenia in frail and pre-frail older adults. The primary endpoint is the sarcopenia diagnostic. In patients with at least one Fried criteria, we would like to detect the number of patient with low lean muscle mass adjusted for body mass index <0.789 for men and <0.512 for women.

Secondary outcomes

  1. (SPPB) score

    Time frame: one day (participation of subject)

    Short Physical Performance Battery (SPPB) score

  2. (MMSE) score

    Time frame: one day (participation of subject)

    Mini-Mental State Examination (MMSE) score

  3. (MNA) score

    Time frame: one day (participation of subject)

    Mini Nutritional Assessment (MNA) score

  4. (IADL) score

    Time frame: one day (participation of subject)

    Instrumental Activities of Daily Living (IADL) score

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

SArcopenia Prevalence in Frail Older Adults: SAF Study

Acronym: SAF

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 16, 2016
Registry last updated
Oct 29, 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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