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SarcopeniaARMS-IINCT02350465

Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans

A study testing Eccentric Exercise and Concentric Exercise in people with Sarcopenia, run by VA Office of Research and Development at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objectives of this study are to: 1) validate a rapid, portable, cost-effective method for screening myosteatosis and sarcopenia using diagnostic ultrasound, and 2) investigate a novel approach to progressive resistance exercise involving eccentric muscle actions that will counter the local effects of myosteatosis… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Sarcopenia
What is being tested?
Eccentric Exercise and Concentric Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
3 sitesUnited States
Study dates
1 Mar 2015to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • An African American adult.
  • Between 18 and 30 years of age, or between 65 and 85 years of age.
  • Able to independently walk at home and in your community (use of an assistive device like a cane or a walker is acceptable).

Who cannot join

  • Uncontrolled hypertension or other cardiovascular disease.
  • A Body Mass Index of 32.5 or above may be an exclusion criterion if the X-ray technician determines that dimensions of the scanning bed are not adequate for a reliable examination.
  • A musculoskeletal condition that would stop you from performing the physical assessment tests.
  • Muscle weakness due to neurological disease or injury (such as stroke or spinal cord injury).
  • Moderate to severe sepsis (blood infection) or edema (such as swelling of a limb).
  • Been hospitalized over the last three months.
  • History of a broken arm or leg bone because of osteoporosis.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Howard University

    Washington D.C., District of Columbia, 20060

Other trials in United States

About this study

The objectives of this study are to: 1) validate a rapid, portable, cost-effective method for screening myosteatosis and sarcopenia using diagnostic ultrasound, and 2) investigate a novel approach to progressive resistance exercise involving eccentric muscle actions that will counter the local effects of myosteatosis and sarcopenia in African Americans.

Read the detailed description

The rationale for this study is the need to proactively address health disparities associated with age-related skeletal muscle dysfunction. Age-related changes in muscle may be characterized by sarcopenia (i.e., loss of muscle mass) and/or myosteatosis (i.e., excessive intramuscular adipose tissue). These changes may result in physical impairments that may be exacerbated by the lack of a formal screening and diagnosis process for older adults in standard healthcare settings. Myosteatosis may compound the effects of sarcopenia and play a significant role the age-related functional decline and higher incidence of type 2 diabetes observed in African Americans in comparison to other ethnic/racial groups. The initial phase of the study will involve the assessment of older African Americans (n = 70) to characterize muscle size and quality in comparison to a younger reference group (n = 70). Participants randomly selected from the older subject pool will be assigned to either the Eccentric Exercise Group or the Concentric Exercise Group for 12 weeks of a supervised strengthening exercise regimen.

Conditions
Sarcopenia
Being tested
Eccentric Exercise, Concentric Exercise
Keywords
sarcopenia, aging, myosteatosis, exercise, screening
Medical subject headings
Sarcopenia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eccentric ExerciseBehavioural

    Also called Negative work training

    Submaximal progressive resistance exercise (PRE) using eccentric muscle actions for the knee extensors/flexors will be performed for 10 repetitions, 3 to 4 sets, twice per week for 12 weeks.

  • Concentric ExerciseBehavioural

    Also called Conventional strength training

    Submaximal progressive resistance exercise (PRE) using concentric muscle actions for the knee extensors/flexors will be performed for 10 repetitions, 3 to 4 sets, twice per week for 12 weeks.

Study groups in NCT02350465
Study groupRoleWhat they receive
Eccentric ExerciseExperimentalSupervised strengthening exercise using eccentric muscle actions.
Receives: Behavioral: Eccentric Exercise
Concentric ExerciseActive comparatorSupervised strengthening exercise using concentric muscle actions.
Receives: Behavioral: Concentric Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Sonographic Lean Body Mass at 3 months

    US estimates of aggregate regional LBM (muscle thickness, cm), will be assessed using B-mode diagnostic US with a 13-6 megahertz (MHz) linear array transducer for morphology measures at 6 axial and appendicular sites.

    Measured: At study baseline for all subjects, and at Week 6 and 12 of the intervention period for subjects randomly assigned to an exercise group

Secondary outcomes (4)

  1. Change from Baseline in dual-energy X-ray absorptiometry (DXA) scanning at 3 months

    Participants will undergo DXA scanning in the supine position per manufacturer guidelines to estimate absolute and percentage of total lean body mass (LBM) and body fat (BF).

    Measured: At study baseline for all subjects, and at Week 12 of the intervention period for subjects randomly assigned to an exercise group

  2. Change from Baseline in metabolic status at 3 months

    A blood sample (60 cc) will be obtained after an 8-hour overnight fast: glucose and insulin levels will be assessed. Other laboratory values will be obtained such as a standard lipid profile and glycated hemoglobin (HbA1C).

    Measured: At study baseline for all subjects

  3. Change from Baseline in intramuscular adipose tissue assessment at 3 months

    Estimates of intramuscular adipose tissue (IMAT) will be obtained with magnetic resonance imaging using a whole body transmit/receive coil for T2 fat image acquisition of the thigh (dominant side) will be obtained at the mid-femur region.

    Measured: At study baseline for all subjects

  4. Change from Baseline in strength assessment at 3 months

    Grip strength will be assessed bilaterally; isometric and isokinetic knee extension/flexion torques will be obtained bilaterally using a dynamometer. Peak concentric torque (at 60 /s and 180 /s) will be obtained in a randomized fashion with subject positioning and stabilization per the manufacturer operations manual.

    Measured: At study baseline for all subjects, and at Week 6 and 12 of the intervention period for subjects randomly assigned to an exercise group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2015 (estimated)
  2. Study start1 Mar 2015
  3. Primary completion31 Aug 2022
  4. Study completion1 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02350465
Sponsor's protocol ID
E1854-W
Other IDs
MIRB01714
Acronym
ARMS-II
Status last verified
May 2023
First submitted
19 Jan 2015
Last updated
2 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Harris-Love MO, Adams B, Hernandez HJ, DiPietro L, Blackman MR. Disparities in the consequences of sarcopenia: implications for African American Veterans. Front Physiol. 2014 Jul 7;5:250. doi: 10.3389/fphys.2014.00250. eCollection 2014. No abstract available.

    PubMed 25071595

  • Harris-Love MO, Monfaredi R, Ismail C, Blackman MR, Cleary K. Quantitative ultrasound: measurement considerations for the assessment of muscular dystrophy and sarcopenia. Front Aging Neurosci. 2014 Jul 14;6:172. doi: 10.3389/fnagi.2014.00172. eCollection 2014. No abstract available.

    PubMed 25071570

  • Harris-Love MO, Seamon BA, Teixeira C, Ismail C. Ultrasound estimates of muscle quality in older adults: reliability and comparison of Photoshop and ImageJ for the grayscale analysis of muscle echogenicity. PeerJ. 2016 Feb 22;4:e1721. doi: 10.7717/peerj.1721. eCollection 2016.

    PubMed 26925339

  • Harris-Love MO, Benson K, Leasure E, Adams B, McIntosh V. The Influence of Upper and Lower Extremity Strength on Performance-Based Sarcopenia Assessment Tests. J Funct Morphol Kinesiol. 2018 Dec;3(4):53. doi: 10.3390/jfmk3040053. Epub 2018 Nov 3.

    PubMed 30533549

  • Harris-Love MO, Avila NA, Adams B, Zhou J, Seamon B, Ismail C, Zaidi SH, Kassner CA, Liu F, Blackman MR. The Comparative Associations of Ultrasound and Computed Tomography Estimates of Muscle Quality with Physical Performance and Metabolic Parameters in Older Men. J Clin Med. 2018 Oct 10;7(10):340. doi: 10.3390/jcm7100340.

    PubMed 30308959

Questions about this trial

What is this clinical trial studying?

A study testing Eccentric Exercise and Concentric Exercise in people with Sarcopenia, run by VA Office of Research and Development at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Sonographic Lean Body Mass at 3 months (time frame: At study baseline for all subjects, and at Week 6 and 12 of the intervention period for subjects randomly assigned to an exercise group). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02350465, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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