NCT02350465

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

7.5 years

First QC Date

January 19, 2015

Last Update Submit

May 30, 2023

Conditions

Sarcopenia

Keywords

sarcopeniaagingmyosteatosisexercisescreening

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (4)

  • 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

  • Change from Baseline in metabolic status at 3 months

    At study baseline for all subjects

  • Change from Baseline in intramuscular adipose tissue assessment at 3 months

    At study baseline for all subjects

  • 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

Study Arms (2)

Eccentric Exercise

EXPERIMENTAL

Supervised strengthening exercise using eccentric muscle actions.

Behavioral: Eccentric Exercise

Concentric Exercise

ACTIVE COMPARATOR

Supervised strengthening exercise using concentric muscle actions.

Behavioral: Concentric Exercise

Interventions

Eccentric ExerciseBEHAVIORAL

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.

Also known as: Negative work training
Eccentric Exercise
Concentric ExerciseBEHAVIORAL

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.

Also known as: Conventional strength training
Concentric Exercise

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Uncontrolled hypertension or other cardiovascular disease.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

Related Publications (5)

  • 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.

    PMID: 25071595BACKGROUND

  • 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.

    PMID: 25071570BACKGROUND

  • 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.

    PMID: 26925339BACKGROUND

  • 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.

    PMID: 30533549RESULT

  • 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.

    PMID: 30308959RESULT

MeSH Terms

Conditions

SarcopeniaMotor Activity

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Study Officials

  • Michael Harris-Love, DSc MPT BS

    Rocky Mountain Regional VA Medical Center, Aurora, CO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 29, 2015

Study Start

March 1, 2015

Primary Completion

August 31, 2022

Study Completion

September 1, 2023

Last Updated

June 2, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)