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

Primary Purpose

Sarcopenia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eccentric Exercise
Concentric Exercise
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring sarcopenia, aging, myosteatosis, exercise, screening

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rocky Mountain Regional VA Medical Center, Aurora, CO
  • University of Colorado Anschutz Medical Campus
  • Howard University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eccentric Exercise

Concentric Exercise

Arm Description

Supervised strengthening exercise using eccentric muscle actions.

Supervised strengthening exercise using concentric muscle actions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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.
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.

Full Information

First Posted
January 19, 2015
Last Updated
May 30, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02350465
Brief Title
Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans
Acronym
ARMS-II
Official Title
Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
sarcopenia, aging, myosteatosis, exercise, screening

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eccentric Exercise
Arm Type
Experimental
Arm Description
Supervised strengthening exercise using eccentric muscle actions.
Arm Title
Concentric Exercise
Arm Type
Active Comparator
Arm Description
Supervised strengthening exercise using concentric muscle actions.
Intervention Type
Behavioral
Intervention Name(s)
Eccentric Exercise
Other Intervention Name(s)
Negative work training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Concentric Exercise
Other Intervention Name(s)
Conventional strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Sonographic Lean Body Mass at 3 months
Description
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.
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
Secondary Outcome Measure Information:
Title
Change from Baseline in dual-energy X-ray absorptiometry (DXA) scanning at 3 months
Description
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).
Time Frame
At study baseline for all subjects, and at Week 12 of the intervention period for subjects randomly assigned to an exercise group
Title
Change from Baseline in metabolic status at 3 months
Description
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).
Time Frame
At study baseline for all subjects
Title
Change from Baseline in intramuscular adipose tissue assessment at 3 months
Description
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.
Time Frame
At study baseline for all subjects
Title
Change from Baseline in strength assessment at 3 months
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Harris-Love, DSc MPT BS
Organizational Affiliation
Rocky Mountain Regional VA Medical Center, Aurora, CO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Howard University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25071595
Citation
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.
Results Reference
background
PubMed Identifier
25071570
Citation
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.
Results Reference
background
PubMed Identifier
26925339
Citation
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.
Results Reference
background
PubMed Identifier
30533549
Citation
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.
Results Reference
result
PubMed Identifier
30308959
Citation
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.
Results Reference
result

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Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans

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