SarcopeniaNCT03984994
Muscle Capillarization and Sarcopenia
A study testing Aerobic exercise training and Strength training in people with Sarcopenia, run by Baltimore VA Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Aerobic exercise training and Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 88 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Body Mass Index = 18-32.5 kg/m2
- Non-smoker
- Presence of at least moderate sarcopenia (low muscle mass per unit body height)
Who cannot join
- Diagnosis of diabetes, cancer, pulmonary or renal disease
- Physical impairment preventing exercise
- Recent history of exercise training
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland, Baltimore & Baltimore VA Medical Center
Baltimore, Maryland, 21201
University of Maryland
College Park, Maryland, 20742
About this study
Official title: Increasing Muscle Capillarization to Enhance Responses to Strength Training in Sarcopenia
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Aerobic exercise training, Strength training
- Keywords
- muscle, capillary, exercise
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingOther
3 months of center-based, supervised treadmill exercise
Strength trainingOther
3 months of center-based, supervise strength training
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Aerobic exercise training; Other: 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 Receives: Other: Aerobic exercise training; Other: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months (post minus pre-resistance training)
Secondary outcomes (2)
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.
Measured: 3 months (post minus pre-resistance 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.
Measured: 3 months (post minus pre-resistance training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start1 Nov 2021
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland, Baltimore, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Steven J. Prior, Ph.D., University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984994
- Sponsor's protocol ID
- HP-00086001
- Other IDs
- 5R21AG064571
- Status last verified
- Oct 2025
- First submitted
- 5 Jun 2019
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Muscle Capillarization to Enhance Responses to Strength Training in Sarcopenia
- ClinicalTrials.gov ID
- NCT03984994
- Acronym / sponsor ID
- HP-00086001
- Conditions
- Sarcopenia
- Keywords
- muscle, capillary, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Collaborators
- University of Maryland, Baltimore, National Institute on Aging (NIA)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise training followed by resistance training | Experimental | Other: Aerobic exercise training, Other: Strength trainingParticipants 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 | Other: Aerobic exercise training, Other: Strength trainingParticipants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training |
Who may qualify
- Ages
- 65 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Body Mass Index = 18-32.5 kg/m2
- Non-smoker
- Presence of at least moderate sarcopenia (low muscle mass per unit body height)
Key exclusion criteria (3 listed)
- Diagnosis of diabetes, cancer, pulmonary or renal disease
- Physical impairment preventing exercise
- Recent history of exercise training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise training3 months of center-based, supervised treadmill exercise | Other | Aerobic exercise training followed by resistance training, Resistance training followed by aerobic exercise training |
| Strength training3 months of center-based, supervise strength training | Other | Aerobic exercise training followed by resistance training, Resistance training followed by aerobic exercise training |
Primary outcome
Skeletal Muscle Capillarization
Time frame: 3 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 Area
Time frame: 3 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.
2 secondary outcomes
Skeletal Muscle Fiber Size
Time frame: 3 months (post minus pre-resistance training)
Muscle Strength
Time frame: 3 months (post minus pre-resistance training)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training and Strength training in people with Sarcopenia, run by Baltimore VA Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Capillarization (time frame: 3 months (post minus pre-resistance training)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.