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Muscle Capillarization and Sarcopenia

Primary Purpose

Sarcopenia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aerobic exercise training

Strength training

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring muscle, capillary, exercise

Eligibility Criteria

65 Years - 88 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Body Mass Index = 18-32.5 kg/m2
Non-smoker
Presence of at least moderate sarcopenia (low muscle mass per unit body height)

Exclusion Criteria:

Diagnosis of diabetes, cancer, pulmonary or renal disease
Physical impairment preventing exercise
Recent history of exercise training

Sites / Locations

University of Maryland, Baltimore & Baltimore VA Medical CenterRecruiting
University of Maryland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic exercise training followed by resistance training

Resistance training followed by aerobic exercise training

Arm Description

Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training

Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training

Outcomes

Primary Outcome Measures

Skeletal muscle capillarization

Change in the number of capillaries per unit of skeletal muscle tissue

Muscle volume

Change in the size of the thigh muscles

Secondary Outcome Measures

Skeletal muscle fiber size

Change in the cross-sectional size of individual thigh skeletal muscle fibers

Muscle strength

Change in the strength/force produced by skeletal muscles of the thigh

Full Information

NCT ID

NCT03984994

First Posted

June 5, 2019

Last Updated

April 12, 2023

Sponsor

Baltimore VA Medical Center

Collaborators

University of Maryland, Baltimore

1. Study Identification

Unique Protocol Identification Number

NCT03984994

Brief Title

Muscle Capillarization and Sarcopenia

Official Title

Increasing Muscle Capillarization to Enhance Responses to Strength Training in Sarcopenia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baltimore VA Medical Center

Collaborators

University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Aging is associated with a loss of muscle mass, termed sarcopenia, that reduces mobility, decreases physical function and accelerates progression of other age-related disorders. This study is designed to determine whether increasing skeletal muscle capillarization through aerobic exercise will enhance muscular adaptations to strength training in older adults with sarcopenia.

Detailed Description

Sarcopenia, or the aging-related loss of muscle mass, affects a large number of older adults. The presence of sarcopenia is associated with physical disability, poor quality of life, and all-cause mortality, in part because sarcopenic adults have low muscle skeletal muscle capillarization and may lack the adequate perfusion needed to maintain muscle mass and function. This study will test the effects of increasing skeletal muscle capillarization through aerobic exercise training on responses to resistance training in older adults. Eligible participants will be randomized to one of two groups, resistance training preceded by aerobic exercise training (AEX-RT), or resistance training followed by aerobic exercise training (RT-AEX). Participants in the AEX-RT group will undergo 3 months of aerobic exercise training to increase skeletal muscle capillarization, followed by 3 months of resistance training. Participants in the RT-AEX group will undergo 3 months of resistance training, followed by 3 months of aerobic exercise training. Before and after the interventions, participants will undergo assessments of muscle size, strength, and capillarization, as well as assessments of physical function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia

Keywords

muscle, capillary, exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

The study employs 2 interventions: resistance training and aerobic exercise training. One group of participants will undergo resistance training then aerobic exercise training; the other group will undergo aerobic exercise training then resistance training.

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aerobic exercise training followed by resistance training

Arm Type

Experimental

Arm Description

Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training

Arm Title

Resistance training followed by aerobic exercise training

Arm Type

Active Comparator

Arm Description

Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training

Intervention Type

Other

Intervention Name(s)

Aerobic exercise training

Intervention Description

3 months of center-based, supervised treadmill exercise

Intervention Type

Other

Intervention Name(s)

Strength training

Intervention Description

3 months of center-based, supervise strength training

Primary Outcome Measure Information:

Title

Skeletal muscle capillarization

Description

Change in the number of capillaries per unit of skeletal muscle tissue

Time Frame

6 months

Title

Muscle volume

Description

Change in the size of the thigh muscles

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Skeletal muscle fiber size

Description

Change in the cross-sectional size of individual thigh skeletal muscle fibers

Time Frame

6 months

Title

Muscle strength

Description

Change in the strength/force produced by skeletal muscles of the thigh

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

88 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Body Mass Index = 18-32.5 kg/m2 Non-smoker Presence of at least moderate sarcopenia (low muscle mass per unit body height) Exclusion Criteria: Diagnosis of diabetes, cancer, pulmonary or renal disease Physical impairment preventing exercise Recent history of exercise training

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Steven J Prior, PhD

Phone

301-405-2483

sprior@umd.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Odessa Addison, PT, PhD

Phone

410-605-7000

Ext

55393

oaddison@som.umaryland.edu

Facility Information:

Facility Name

University of Maryland, Baltimore & Baltimore VA Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bailey Rammling, M.S.

Phone

443-488-3749

bailey.rammling@va.gov

Facility Name

University of Maryland

City

College Park

State/Province

Maryland

ZIP/Postal Code

20742

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Catherine Sapp, MS

Phone

301-405-2483

CMMLab@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Muscle Capillarization and Sarcopenia

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