- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03984994
Muscle Capillarization and Sarcopenia
January 23, 2024 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
Active, not recruiting
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)
32
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: 6 months
|
Change in the number of capillaries per unit of skeletal muscle tissue
|
6 months
|
Muscle volume
Time Frame: 6 months
|
Change in the size of the thigh muscles
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skeletal muscle fiber size
Time Frame: 6 months
|
Change in the cross-sectional size of individual thigh skeletal muscle fibers
|
6 months
|
Muscle strength
Time Frame: 6 months
|
Change in the strength/force produced by skeletal muscles of the thigh
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Estimated)
April 30, 2024
Study Completion (Estimated)
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 (Actual)
January 24, 2024
Last Update Submitted That Met QC Criteria
January 23, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00086001
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
-
University of Texas at AustinNot yet recruitingExercise Training and SarcopeniaUnited States
-
Centre Hospitalier Universitaire DijonCompleted
-
Creighton UniversityUniversity of NebraskaRecruiting
-
University Hospital, CaenCompleted
-
University of NottinghamUniversity of OxfordRecruitingMuscle Atrophy | Age-Related SarcopeniaUnited Kingdom
-
Tufts UniversityNational Institute on Aging (NIA)CompletedMuscle Loss | Age-Related SarcopeniaUnited States
-
China Medical University HospitalCompleted
-
King's College LondonCo-sponsor: Guy's and St Thomas' NHS Foundation TrustCompletedFrailty | Sarcopenia | Age-Related SarcopeniaUnited Kingdom
-
Norwegian School of Sport SciencesOslo University HospitalNot yet recruitingHealthy Aging | Testosterone Deficiency | Age-Related Sarcopenia
-
Ningbo Medical Center Lihuili HospitalCompletedHemodialysis Patients With SarcopeniaChina
Clinical Trials on Aerobic exercise training
-
UNC Lineberger Comprehensive Cancer CenterCompletedStem Cell Transplantation, HematopoieticUnited States
-
National Taiwan University HospitalCompletedAtrial FibrillationTaiwan
-
Riphah International UniversityCompletedSpinal Cord InjuriesPakistan
-
University of HoustonTerminated
-
Istanbul University - Cerrahpasa (IUC)CompletedObstructive Sleep Apnea SyndromeTurkey
-
University of Alberta, Physical EducationCanadian Breast Cancer Research AllianceCompleted
-
Chang Gung Memorial HospitalCompleted
-
Chang Gung Memorial HospitalUnknownStroke Patients With Cognitive DeclineTaiwan
-
Federal University of UberlandiaSuspendedHypertension | Dyslipidemias | Multimorbidity | Multiple Chronic ConditionsBrazil
-
Parkwood Hospital, London, OntarioCanadian Institutes of Health Research (CIHR); University of Western Ontario...CompletedCognitive ImpairmentCanada