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

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Active, not recruiting

CT.gov ID

NCT02350465

Collaborator

(none)

136

Enrollment

Locations

Arms

Anticipated Duration (Months)

45.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia	Behavioral: Eccentric Exercise Behavioral: Concentric Exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

136 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 :

Mar 1, 2015

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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 Names: 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 Names: Conventional strength training

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 Names:

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 Names:

Conventional strength training

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado	United States	80045
2	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045
3	Howard University	Washington	District of Columbia	United States	20060