Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans

Not Applicable

Active, not recruiting

• Conditions: Sarcopenia
• Interventions: Behavioral: Eccentric Exercise; Behavioral: Concentric Exercise

• Registration Number: NCT02350465
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-25
• Study First Posted: 2015-01-29
• Study Start: 2015-03-01
• Primary Completion: 2022-08-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-02
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 136

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).

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eccentric Exercise	Eccentric Exercise	Supervised strengthening exercise using eccentric muscle actions.
Concentric Exercise	Concentric Exercise	Supervised strengthening exercise using concentric muscle actions.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Sonographic Lean Body Mass at 3 months	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

Name	Time	Method
Change from Baseline in dual-energy X-ray absorptiometry (DXA) scanning at 3 months	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).
Change from Baseline in metabolic status at 3 months	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).
Change from Baseline in intramuscular adipose tissue assessment at 3 months	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.
Change from Baseline in strength assessment at 3 months	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.

Trial Locations

Locations (3)

Rocky Mountain Regional VA Medical Center, Aurora, CO; 🇺🇸 Aurora, Colorado, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Howard University; 🇺🇸 Washington, District of Columbia, United States