Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans (ARMS-II)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02350465|
Recruitment Status : Active, not recruiting
First Posted : January 29, 2015
Last Update Posted : March 4, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Sarcopenia||Behavioral: Eccentric Exercise Behavioral: Concentric Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans|
|Actual Study Start Date :||March 1, 2015|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||December 30, 2022|
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
- 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.
- 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).
- 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).
- 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.
- 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|
- 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).
- 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.
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
|United States, Colorado|
|Rocky Mountain Regional VA Medical Center, Aurora, CO|
|Aurora, Colorado, United States, 80045|
|University of Colorado Anschutz Medical Campus|
|Aurora, Colorado, United States, 80045|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20060|
|Principal Investigator:||Michael Harris-Love, DSc MPT BS||Rocky Mountain Regional VA Medical Center, Aurora, CO|
|Responsible Party:||VA Office of Research and Development|
|Other Study ID Numbers:||
MIRB01714 ( Other Identifier: Washington D.C. Veterans Affairs Medical Center )
|First Posted:||January 29, 2015 Key Record Dates|
|Last Update Posted:||March 4, 2022|
|Last Verified:||February 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
Nervous System Diseases
Pathological Conditions, Anatomical