SArcopenia Prevalence in Frail Older Adults. SAF Study

NCT02903992 | Completed DMC

• 2 other identifiers: RC31/15/78172016-A00181-50
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Keywords

Frail Elderly; sarcopenia

Outcome Measures

Primary Outcomes (1)

• Sarcopenia Diagnostic with Dual-energy X-ray absorptiometry

  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.

  one day (participation of subject)

Secondary Outcomes (4)

• (SPPB) score

  one day (participation of subject)

• (MMSE) score

  one day (participation of subject)

• (MNA) score

  one day (participation of subject)

• (IADL) score

  one day (participation of subject)

Study Arms (1)

All patients recruited

OTHER

All patients who are enrolled in study 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.

Radiation: Dual-energy X-ray absorptiometry (DXA)

Interventions

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.

All patients recruited

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Bertrand FOUGERE, MD, Ph D

  oulouse University Hospital (CHU de Toulouse)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: September 16, 2016
• Study Start: May 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 1, 2019
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)