Use of the Sit-To-Stand Task as a Screening Tool for Sarcopenia The

NCT03308903 | Unknown FDA Device

• 1 other identifier: IHREC751
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A common condition associated with ageing is sarcopenia, which is a progressive decrease in muscle mass. Sarcopenia is associated with adverse outcomes including increased mortality, and places a major burden on healthcare spending, with the annual cost of sarcopenia in the United States exceeding that of osteoporosis and hip fracture. In the UK, the prevalence of sarcopenia in community-dwelling older people has been estimated at 5% for men and 8% for women. Current guidelines for sarcopenia diagnosis require muscle mass to be measured using costly devices such as Dual Energy X-ray Absorptiometry (DXA) and Magnetic Resonance Imaging (MRI). Previous research has found strong relationships between the sit-to-stand (STS) test and both muscle mass and muscle strength. This pilot study aims to examine this relationship in community-dwelling older people to develop predictive equations for initial screening of sarcopenia. Forty subjects will be tested using the diagnostic criteria developed by the European Working Group on Sarcopenia in Older People (EWGSOP). Muscle mass will be measured using the DXA and diagnostic ultrasound. Muscle strength will be measured using isokinetic dynamometer, handgrip dynamometry, and hand-held dynamometry. Functional performance will be measured using the Timed-up-and-Go and gait velocity, and the STS. Subjects will perform two variants of the STS; the five times STS (5STS), which requires subjects to perform five consecutive STS movements as quick as possible, and the 30-second STS (30STS), which requires subjects to perform as many STS movements as possible in 30 seconds. All testing will be completed in a single session lasting 90 minutes for each subject. Testing will be performed at the University of Bedfordshire Polhill Campus. Subject recruitment will be recruited using advertisement posters and word of mouth.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Muscle mass measurement using dual X-ray absorptiometry

  The participant will undergo a whole-body DEXA (DEXA; GE Medical Systems, Chalfont St Giles, UK) scan, lasting approximately 5 minutes. This scan will produce body composition data, including M and body fat percentage (BF%). For the purpose of this study, aLM values will be calculated in relation to height (sum of LBM in the arms and legs, scaled to height) (aLM/ht²).

  5 minutes

Secondary Outcomes (8)

• Hip and knee flexion and extension and ankle plantarflexion and dorsiflexion of both lower extremities on the Biodex System 3 Isokinetic Dynamometer

  5 minutes

• Five times sit to stand test

  5 minutes

• Diagnostic ultrasound

  5 minutes

• Grip strength

  5 minutes

• Handheld dynamometer assessment of muscle strength

  5 minutes

Interventions

DEXA scan DIAGNOSTIC_TEST

The participant will undergo a whole-body DEXA (DEXA; GE Medical Systems, Chalfont St Giles, UK) scan, lasting approximately 5 minutes. This scan will produce body composition data, including estimates of lean body mass (LBM), appendicular lean mass (aLM) and body fat percentage (BF%).

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling people aged 65 years and over with no musculoskeletal problems.

You may qualify if:

• Male or female
• Community-dwelling adults
• Aged 65+ years

You may not qualify if:

• Cardiovascular and/or respiratory problems
• High blood pressure (140/90mmHG or higher)
• Low blood pressure (90/60mmHg or lower)
• A diagnosis of arthritis and/or osteoporosis
• Had a musculoskeletal injury within the last twelve months
• Had an X-ray examination with contrast medium in the 3 weeks prior to the DEXA scan (if this does apply to the participant, the date of which they will participate will be delayed until 3 weeks after the date of their contrast scan)
• Recently had a Nuclear Medicine diagnostic or therapy investigation, depending on its nature (this will be referred to the Medical Physics Expert to determine if and when the participant can receive a DEXA scan for this study)
• Any significant internal metalwork or irremovable external metalwork.

Sponsors & Collaborators

• University of Bedfordshire: lead

Study Sites (1)

University of Bedfordshire

Bedford, Bedfordshire, MK41 9EA, United Kingdom

RECRUITING

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

Central Study Contacts

David Hewson, PhD

CONTACT

0044 7525616645; david.hewson@beds.ac.uk

Daniel Bailey, PhD

CONTACT

0044 1234793237; daniel.bailey@beds.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health and Ageing

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 13, 2017
• Study Start: January 22, 2018
• Primary Completion: January 31, 2019
• Study Completion: March 31, 2019
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

GB (1)