- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03984994
Muscle Capillarization and Sarcopenia
October 15, 2025 updated by: Steven J. Prior, Ph.D., Baltimore VA Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland, Baltimore & Baltimore VA Medical Center
-
College Park, Maryland, United States, 20742
- University of Maryland
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 88 years (Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
3 months of center-based, supervised treadmill exercise
3 months of center-based, supervise strength training
|
|
Active Comparator: 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
|
3 months of center-based, supervised treadmill exercise
3 months of center-based, supervise strength training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months (post minus pre-resistance training)
|
|
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.
|
3 months (post minus pre-resistance training)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skeletal Muscle Fiber Size
Time Frame: 3 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.
|
3 months (post minus pre-resistance training)
|
|
Muscle Strength
Time Frame: 3 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.
|
3 months (post minus pre-resistance training)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
April 30, 2024
Study Registration Dates
First Submitted
June 5, 2019
First Submitted That Met QC Criteria
June 12, 2019
First Posted (Actual)
June 13, 2019
Study Record Updates
Last Update Posted (Estimated)
October 29, 2025
Last Update Submitted That Met QC Criteria
October 15, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Sarcopenia
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- HP-00086001
- 5R21AG064571 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcopenia
-
Cairo UniversityNot yet recruitingGeriatric SarcopeniaEgypt
-
University Hospital, BonnRecruiting
-
Shanghai Yueyang Integrated Medicine HospitalShanghai University of Traditional Chinese Medicine; DongE E Jiao Coporation... and other collaboratorsNot yet recruiting
-
Assiut UniversityNot yet recruiting
-
TNF Pharmaceuticals, Inc.Not yet recruitingFrailty | Sarcopenia in Elderly | Frailty/Sarcopenia | Frailty in Older Adults
-
University of ExtremaduraCompletedSarcopenia in Elderly | Institutionalized Older Adults | HIITSpain
-
Animuscure Inc.Recruiting
-
West China HospitalNot yet recruitingSarcopenia in Elderly
-
Centre Hospitalier Universitaire DijonCompleted
-
Medway NHS Foundation TrustNot yet recruitingFalls | Sarcopenia in ElderlyUnited Kingdom
Clinical Trials on Aerobic exercise training
-
Gazi UniversityActive, not recruiting
-
UNC Lineberger Comprehensive Cancer CenterCompletedStem Cell Transplantation, HematopoieticUnited States
-
National Taiwan University HospitalCompletedAtrial FibrillationTaiwan
-
Riphah International UniversityCompletedSpinal Cord InjuriesPakistan
-
Istinye UniversityNot yet recruitingCOPD (Chronic Obstructive Pulmonary Disease)
-
Bezmialem Vakif UniversityThe Scientific and Technological Research Council of TurkeyCompletedDown Syndrome | Cognitive Function | Functional Capacity | Aerobic Exercise | Physical Fitness | Virtual Reality Based Therapy | ExergameTurkey (Türkiye)
-
Istanbul University - Cerrahpasa (IUC)CompletedObstructive Sleep Apnea SyndromeTurkey
-
University of HoustonTerminated
-
University of AlbertaCanadian Breast Cancer Research AllianceCompleted
-
Chang Gung Memorial HospitalCompleted