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Muscle Capillarization and Sarcopenia

Increasing Muscle Capillarization to Enhance Responses to Strength Training in Sarcopenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03984994
Enrollment
14
Registered
2019-06-13
Start date
2021-11-01
Completion date
2024-04-30
Last updated
2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

muscle, capillary, exercise

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.

Interventions

OTHERAerobic exercise training

3 months of center-based, supervised treadmill exercise

OTHERStrength training

3 months of center-based, supervise strength training

Sponsors

University of Maryland, Baltimore
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Baltimore VA Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
65 Years to 88 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Skeletal Muscle Capillarization3 months (post minus pre-resistance training)Change in the number of capillaries per unit of skeletal muscle tissue after resistance training. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.
Quadriceps Muscle Cross-sectional Area3 months (post minus pre-resistance training)Change in the size of the thigh muscles. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.

Secondary

MeasureTime frameDescription
Skeletal Muscle Fiber Size3 months (post minus pre-resistance training)Change in the cross-sectional size of individual thigh skeletal muscle fibers. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.
Muscle Strength3 months (post minus pre-resistance training)Change in the strength/force produced by skeletal muscles of the thigh. Only the resistance training-induced change (post minus pre-resistance training) is reported as this is the primary outcome for each arm.

Countries

United States

Participant flow

Pre-assignment details

Participants are assigned to groups upon completion of baseline testing.

Participants by arm

ArmCount
Aerobic Exercise Training Followed by Resistance Training
Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training
7
Resistance Training Followed by Aerobic Exercise Training
Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training
7
Total14

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject21

Baseline characteristics

CharacteristicAerobic Exercise Training Followed by Resistance TrainingTotalResistance Training Followed by Aerobic Exercise Training
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
7 Participants14 Participants7 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous78 years
STANDARD_DEVIATION 4
75 years
STANDARD_DEVIATION 6
73 years
STANDARD_DEVIATION 6
Appendicular Lean Mass (kg)17.1 kilograms
STANDARD_DEVIATION 1.9
18.4 kilograms
STANDARD_DEVIATION 4.4
19.3 kilograms
STANDARD_DEVIATION 5.4
Quadriceps muscle strength (Newton*meters)91 Newton*meters
STANDARD_DEVIATION 15
101 Newton*meters
STANDARD_DEVIATION 25
107 Newton*meters
STANDARD_DEVIATION 30
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants5 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
6 Participants8 Participants2 Participants
Region of Enrollment
United States
7 participants14 participants7 participants
Sex: Female, Male
Female
4 Participants9 Participants5 Participants
Sex: Female, Male
Male
3 Participants5 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 70 / 7
other
Total, other adverse events
0 / 70 / 7
serious
Total, serious adverse events
0 / 70 / 7

Outcome results

Primary

Quadriceps Muscle Cross-sectional Area

Change in the size of the thigh muscles. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.

Time frame: 3 months (post minus pre-resistance training)

Population: All participants completing the resistance training portion of the intervention in each arm were analyzed. Only data for the resistance training portion of the study are reported (change post-pre training). Data and analyses are not reported for aerobic exercise as this was not part of the aims/outcomes and was only assessed to gauge responses to only RT.

ArmMeasureValue (MEAN)Dispersion
Aerobic Exercise Training Followed by Resistance TrainingQuadriceps Muscle Cross-sectional Area2.5 square centimetersStandard Error 2
Resistance Training Followed by Aerobic Exercise TrainingQuadriceps Muscle Cross-sectional Area0.7 square centimetersStandard Error 2.6
Comparison: Per the aims of the study, the responses to RT were compared between 2 arms/groups. The change in the outcome (post-RT minus pre-RT) in each arm/group was compared using a t-test. Responses to AEX training itself are not assessed as this was not an aim or hypothesis of the study.~The hypothesis was that the Aerobic exercise training followed by resistance training arm would have greater changes/improvements in study outcomes than the Resistance training followed by aerobic training group.p-value: 0.22t-test, 2 sided
Primary

Skeletal Muscle Capillarization

Change in the number of capillaries per unit of skeletal muscle tissue after resistance training. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.

Time frame: 3 months (post minus pre-resistance training)

Population: All participants completing the resistance training portion of the intervention in each arm were analyzed. Only data for the resistance training portion of the study are reported (change post-pre training). Data and analyses are not reported for aerobic exercise as this was not part of the aims/outcomes and was only assessed to gauge responses to only RT.

ArmMeasureValue (MEAN)Dispersion
Aerobic Exercise Training Followed by Resistance TrainingSkeletal Muscle Capillarization0.4 capillaries per muscle fiberStandard Error 0.1
Resistance Training Followed by Aerobic Exercise TrainingSkeletal Muscle Capillarization0.2 capillaries per muscle fiberStandard Error 0.1
Comparison: Per the aims of the study, the responses to RT were compared between 2 arms/groups. The change in the outcome (post-RT minus pre-RT) in each arm/group was compared using a t-test. Responses to AEX training itself are not assessed as this was not an aim or hypothesis of the study.~The hypothesis was that the Aerobic exercise training followed by resistance training arm would have greater changes/improvements in study outcomes than the Resistance training followed by aerobic training group.p-value: 0.27t-test, 2 sided
Secondary

Muscle Strength

Change in the strength/force produced by skeletal muscles of the thigh. Only the resistance training-induced change (post minus pre-resistance training) is reported as this is the primary outcome for each arm.

Time frame: 3 months (post minus pre-resistance training)

Population: All participants completing the resistance training portion of the intervention in each arm were analyzed. Only data for the resistance training portion of the study are reported (change post-pre training). Data and analyses are not reported for aerobic exercise as this was not part of the aims/outcomes and was only assessed to gauge responses to only RT.

ArmMeasureValue (MEAN)Dispersion
Aerobic Exercise Training Followed by Resistance TrainingMuscle Strength12.7 Newton-metersStandard Error 2.3
Resistance Training Followed by Aerobic Exercise TrainingMuscle Strength2.0 Newton-metersStandard Error 5.8
Comparison: Per the aims of the study, the responses to RT were compared between 2 arms/groups. The change in the outcome (post-RT minus pre-RT) in each arm/group was compared using a t-test. Responses to AEX training itself are not assessed as this was not an aim or hypothesis of the study.~The hypothesis was that the Aerobic exercise training followed by resistance training arm would have greater changes/improvements in study outcomes than the Resistance training followed by aerobic training group.p-value: 0.28t-test, 2 sided
Secondary

Skeletal Muscle Fiber Size

Change in the cross-sectional size of individual thigh skeletal muscle fibers. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.

Time frame: 3 months (post minus pre-resistance training)

Population: All participants completing the resistance training portion of the intervention in each arm were analyzed. Only data for the resistance training portion of the study are reported (change post-pre training). Data and analyses are not reported for aerobic exercise as this was not part of the aims/outcomes and was only assessed to gauge responses to only RT.

ArmMeasureValue (MEAN)Dispersion
Aerobic Exercise Training Followed by Resistance TrainingSkeletal Muscle Fiber Size607 square micrometersStandard Error 108
Resistance Training Followed by Aerobic Exercise TrainingSkeletal Muscle Fiber Size356 square micrometersStandard Error 227
Comparison: Per the aims of the study, the responses to RT were compared between 2 arms/groups. The change in the outcome (post-RT minus pre-RT) in each arm/group was compared using a t-test. Responses to AEX training itself are not assessed as this was not an aim or hypothesis of the study.~The hypothesis was that the Aerobic exercise training followed by resistance training arm would have greater changes/improvements in study outcomes than the Resistance training followed by aerobic training group.p-value: 0.21t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026