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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03308903
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Prof David Hewson, University of Bedfordshire

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.


Condition or disease Intervention/treatment
Sarcopenia Diagnostic Test: DEXA scan

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Can the Sit-to-Stand Test be Used as a Screening Tool to Detect Sarcopenia in Community-dwelling Older People?
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : March 31, 2019

Intervention Details:
  • Diagnostic Test: DEXA scan
    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%).


Primary Outcome Measures :
  1. Muscle mass measurement using dual X-ray absorptiometry [ Time Frame: 5 minutes ]
    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).


Secondary Outcome Measures :
  1. Hip and knee flexion and extension and ankle plantarflexion and dorsiflexion of both lower extremities on the Biodex System 3 Isokinetic Dynamometer [ Time Frame: 5 minutes ]
    Participants will perform two sets of five repetitions of hip and knee flexion and extension and ankle plantarflexion and dorsiflexion of both lower extremities on the Biodex System 3 Isokinetic Dynamometer (IKD) (Suffolk, UK), with a 2-minute rest period between sets. The angular velocity of the IKD will be set at 60º/s.

  2. Five times sit to stand test [ Time Frame: 5 minutes ]
    Participants will sit in a straight back chair with a solid seat that is 16" high. Participants will have their arms folded across their chest. They will then stand up and sit down as quickly as possible five times, keeping their arms folded across their chest. The test is measured with a stopwatch and is completed when the participant stands for the 5th time.

  3. Diagnostic ultrasound [ Time Frame: 5 minutes ]
    Sonographic estimates of LBM will be measured using a diagnostic ultrasound. Muscle thickness measurements will be taken from both arms and legs of the participants.

  4. Grip strength [ Time Frame: 5 minutes ]
    A measure of handgrip strength will be taken using the JAMAR PLUS + (Patterson Medical, IL, USA) of both the participant's upper extremities. Measures will be taken twice with a 2-minute rest period between trials. This requires the participant to exert their maximal grip in an isometric contraction.

  5. Handheld dynamometer assessment of muscle strength [ Time Frame: 5 minutes ]
    Measures of isometric muscle strength will be measured using the hand-held dynamometer (HHD). Measures will be taken from the hip flexors, quadriceps, hamstrings, gastroc-soleus complex and tibialis anterior of both lower extremities.

  6. Timed Up and Go test [ Time Frame: 2 minutes ]

    The participant sits on a standard armchair, placing his/her back against the chair and resting his/her arms chair's arms. The participant is instructed to use a comfortable and safe walking speed. The participant walks to a line that is 3 meters away, turns around at the line, walks back to the chair, and sits down. The test ends when the patient's buttocks touch the seat.

    A stopwatch is used to time the test (in seconds).


  7. 30-second sit to stand test [ Time Frame: 5 minutes ]
    Participants will sit in a straight back chair with a solid seat that is 16" high. Participants will have their arms folded across their chest. They will then stand up and sit down as quickly as possible for 30 seconds, keeping their arms folded across their chest. The test is measured with a stopwatch and is completed after 30 seconds, with the number of completed sit to stands taken as the score.

  8. Gait velocity [ Time Frame: 2 minutes ]
    Participants will be asked to walk at a comfortable pace between two lines, marked five metres apart. The time taken will be measured with a stopwatch, with total time taken as the score.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community-dwelling people aged 65 years and over with no musculoskeletal problems.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308903


Contacts
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Contact: David Hewson, PhD 0044 7525616645 david.hewson@beds.ac.uk
Contact: Daniel Bailey, PhD 0044 1234793237 daniel.bailey@beds.ac.uk

Locations
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United Kingdom
University of Bedfordshire Recruiting
Bedford, Bedfordshire, United Kingdom, MK41 9EA
Contact: David Hewson, PhD    0044 7525 616645    david.hewson@beds.ac.uk   
Sponsors and Collaborators
University of Bedfordshire
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Responsible Party: Prof David Hewson, Professor of Health and Ageing, University of Bedfordshire
ClinicalTrials.gov Identifier: NCT03308903    
Other Study ID Numbers: IHREC751
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms