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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21AG064571 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Maryland, Baltimore | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic exercise training followed by resistance training | Experimental | Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training |
|
| Resistance training followed by aerobic exercise training | Active Comparator | Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise training | Other | 3 months of center-based, supervised treadmill exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months (post minus pre-resistance training) |
| 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. | 3 months (post minus pre-resistance training) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months (post minus pre-resistance training) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore & Baltimore VA Medical Center | Baltimore | Maryland | 21201 | United States | ||
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Participants are assigned to groups upon completion of baseline testing.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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All participants assigned to an intervention are included.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | capillaries per muscle fiber | 3 months (post minus pre-resistance training) |
|
Data were collected over 6 months of study participation
The study adhered to clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven J. Prior | University of Maryland | 301-405-2483 | sprior@umd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2024 | Oct 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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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.
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| Strength training | Other | 3 months of center-based, supervise strength training |
|
| 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. | 3 months (post minus pre-resistance training) |
| University of Maryland |
| College Park |
| Maryland |
| 20742 |
| United States |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Appendicular Lean Mass (kg) | Mean | Standard Deviation | kilograms |
|
| Quadriceps muscle strength (Newton*meters) | Mean | Standard Deviation | Newton*meters |
|
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
| OG001 | 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 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | square centimeters | 3 months (post minus pre-resistance training) |
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|
|
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| 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. | 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. | Posted | Mean | Standard Error | square micrometers | 3 months (post minus pre-resistance training) |
|
|
|
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| 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. | 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. | Posted | Mean | Standard Error | Newton-meters | 3 months (post minus pre-resistance training) |
|
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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 | 0 | 7 | 0 | 7 | 0 | 7 |
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| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |