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Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans (ARMS-II)

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ClinicalTrials.gov Identifier: NCT02350465
Recruitment Status : Recruiting
First Posted : January 29, 2015
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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 and sarcopenia in African Americans.

Condition or disease Intervention/treatment Phase
Sarcopenia Behavioral: Eccentric Exercise Behavioral: Concentric Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans
Actual Study Start Date : March 1, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Eccentric Exercise
Supervised strengthening exercise using eccentric muscle actions.
Behavioral: Eccentric Exercise
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.
Other Name: Negative work training

Active Comparator: Concentric Exercise
Supervised strengthening exercise using concentric muscle actions.
Behavioral: Concentric Exercise
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.
Other Name: Conventional strength training




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Change from Baseline in dual-energy X-ray absorptiometry (DXA) scanning at 3 months [ Time Frame: At study baseline for all subjects, and at Week 12 of the intervention period for subjects randomly assigned to an exercise group ]
    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).

  2. Change from Baseline in metabolic status at 3 months [ Time Frame: At study baseline for all subjects ]
    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).

  3. Change from Baseline in intramuscular adipose tissue assessment at 3 months [ Time Frame: At study baseline for all subjects ]
    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.

  4. Change from Baseline in strength assessment 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 ]
    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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

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): NCT02350465


Contacts
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Contact: Michael Harris-Love, DSc MPT BS (202) 745-8240 michael.harris-love@va.gov
Contact: Erin E Leasure, BS (202) 745-8000 ext 55828 Erin.Leasure@va.gov

Locations
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United States, District of Columbia
Howard University Recruiting
Washington, District of Columbia, United States, 20060
Contact: Alice Ukaegbu, MSN    202-865-4272    gcrc@howard.edu   
Washington DC VA Medical Center, Washington, DC Recruiting
Washington, District of Columbia, United States, 20422
Contact: Michael Harris-Love, DSc MPT BS    202-745-8240    michael.harris-love@va.gov   
Sub-Investigator: Haniel J Hernandez, DPT         
Sub-Investigator: Marc R Blackman, MD         
Principal Investigator: Michael Harris-Love, DSc MPT BS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Michael Harris-Love, DSc MPT BS Washington DC VA Medical Center, Washington, DC

Publications:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02350465     History of Changes
Other Study ID Numbers: E1854-W
MIRB01714 ( Other Identifier: Washington D.C. Veterans Affairs Medical Center )
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
sarcopenia
aging
myosteatosis
exercise
screening
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