AgingREALPANCT03771417
Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health
A study testing Exercise Intervention in people with Aging and Sarcopenia, run by Louisiana State University and A&M College at 2 sites in United States.
Trial summary
What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal muscle health in older adults? What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Sarcopenia, Disability Physical
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jan 2019to 9 Feb 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Are capable and willing to give written informed consent, and understand exclusion criteria
- 65-80 years of age inclusive
- Body Mass Index (BMI) between 18.5-34.9 kg/m2, inclusive
- Physically inactive determined by self-report
- Stable medical therapy for allowable medications for 30 days defined as:
- No addition or removal of a medication
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- No change in dosage of a medication
- Having no life-threatening conditions or diseases
- Willing to allow researchers to use data, bio-specimens (blood and muscle tissue), and images (e.g., magnetic resonance imaging) for research purposes after study participation is completed
- At least 2 weeks post-completion of the COVID19 vaccine regimen. a. Acceptable proof of vaccine includes a completed vaccine card and/or letter from a healthcare provider indicating the date that the COVID19 vaccine was completed.
Who cannot join
- Nursing home resident
- Physically Active:
- > 100 min/wk of moderate OR > 50 min/wk vigorous intensity PA
- Saint Louis University Mental State (SLUMS) score < 21
- Evidence or self-report history of deep vein thrombosis, pulmonary embolism, cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease
- Evidence or self-report history of type 1 or 2 diabetes mellitus
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- Evidence or self-report history of a bleeding disorder
- Evidence or self-report history of recurrent vasovagal episodes
- Evidence or self-report history of severe depression, Schizophrenia, bipolar disease
- Evidence or self-report history of mobility disability requiring a walker, wheel chair, or inability to walk across a small room.
- Evidence or self-report history of orthopedic limitations that would preclude them from participation in a dynamic exercise program
- Evidence or self-report history of severe arthritis (either osteoarthritis or rheumatoid arthritis) that would preclude them from participation in a dynamic exercise program
- Evidence or self-report of history untreated thyroid dysfunction.
- Weight loss of > 10% in the last 3 months prior to screening
- History of weight loss surgery.
- Use of medications known to influence study outcomes, such as:
- Insulin
- Oral antidiabetic medications (e.g., metformin)
- Corticosteroids
- Beta-blockers
- Anticoagulants
- Allergy to lidocaine
- Active smoking
- Current consumption of > 14 alcoholic drinks per week based on self-report
- Regular participation in resistance or aerobic exercise training within 3 months of initial screening
- Absolute Contraindication to Exercise as Defined by the American College of Sports Medicine,16 including:
- Resting diastolic blood pressure > 100 mm Hg
- Resting systolic blood pressure > 180 mm Hg
- Resting heart rate > 100 beats per min
- Having a body weight greater than 440 pounds
- Having medical implants such as a pacemaker or metal joint replacements
- Having tattoos or permanent makeup completed <30 days prior to the visit
- Recent (past 3 months) cancer diagnosis, undergoing immunotherapy, taking immune suppressants
- Presence of allergies or infections requiring antibiotics within the past 14 days
- Recent (past 3 months) major surgery on the abdomen, pelvis, or lower extremities
- Any other condition that in the judgement of the Principal Investigator and/or the Medical Director of this protocol may interfere with study participation and adherence to the protocol.
- Evidence or self-report history of severe depression in the last 5 years.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lousiana State University
Baton Rouge, Louisiana, 70803
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Skeletal Muscle and Cardiometabolic Health in Older Adults-REALPA Breaks in Sedentary Time Pilot Study
What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal muscle health in older adults?
What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal cardiometabolic health in older adults?
Read the detailed description
Although awareness of the detrimental impact that sedentary behavior has on skeletal muscle and cardiometabolic health has increased over the last 20 years, more than 60% of older adults remain sedentary for greater than 8 hours per day. Moreover, 80% to 90% of adults 60 years of age or older do not meet the current public health guidelines for aerobic exercise (AE) or resistance exercise (RE) based physical activity (PA). Collectively, these adverse health behaviors contribute to the development of multiple chronic medical conditions commonly afflicting older adults, including type 2 diabetes, cardiovascular disease, sarco/dynapenia, frailty, and premature mortality. Emerging evidence suggests that breaking up sedentary time with light intensity PA (LPA) improves muscle and cardiometabolic health. Recent data also suggest that RE combined with moderate intensity AE effectively improves muscle and cardiometabolic health in older adults. However, the impact that RE combined with LPA breaks in sedentary time has on muscle and cardiometabolic health in older adults remains unknown. The overall objective of this pilot study is to determine the effect of 16 weeks of RE alone or RE combined with LPA breaks in sedentary time on muscle and cardiometabolic health.
- Conditions
- Aging, Sarcopenia, Disability Physical, Cardiovascular Diseases, Insulin Resistance, Diabetes Mellitus
- Being tested
- Exercise Intervention
- Medical subject headings
- Sarcopenia, Cardiovascular Diseases, Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
The use of exercise to improve muscle and cardiometabolic health in older adults.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise | Experimental | Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week. Receives: Behavioral: Exercise Intervention |
| RE plus Low Intensity Physical Activity | Experimental | Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week and regular unsupervised low intensity physical activity breaks in sedentary time 5 days per week [6x10 min breaks/d at 2 metabolic equivalents (METS) or ~30-40% peak oxygen consumption (VO2 peak), ~500 kcal/wk above resting metabolism]. Receives: Behavioral: Exercise Intervention |
| RE plus Moderate IntensityExercise | Active comparator | Exercise Intervention: Participants will be asked to complete supervised RE 2 days per week and supervised calorically matched moderate intensity physical activity 3 days per week (50 min/session at 4 METS (~60-75% VO2 peak), ~500 kcal/week above resting metabolism). Receives: Behavioral: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Strength
The investigators will determine the change from baseline in skeletal muscle strength. These measurements will be performed at baseline and following 16 weeks of exercise training using isokinetic dynamometry and 1 repetition maximum testing.
Measured: Measured at week 0 (baseline) and week 16
Skeletal Muscle Mass
The investigators will determine the change from baseline in skeletal muscle mass. These measurements will be performed at baseline and following 16 weeks of exercise training using Dual X-Ray Absorptiometry.
Measured: Measured at week 0 (baseline) and week 16
Secondary outcomes (1)
Mitochondrial Function
The investigators will determine the change from baseline in mitochondrial function. These measurements will be performed at baseline and following 16 weeks of exercise training.
Measured: Measured at week 0 (baseline) and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start16 Jan 2019
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University and A&M College
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Brian Irving, Louisiana State University and A&M College
- Investigators
- Brian Irving, PhD, Principal investigator, Louisiana State University and A&M College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771417
- Sponsor's protocol ID
- 2018-026
- Other IDs
- R21AG058181
- Acronym
- REALPA
- Status last verified
- Mar 2025
- First submitted
- 7 Dec 2018
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marazzato F, McCarthy C, Field RH, Nguyen H, Nguyen T, Shepherd JA, Tinsley GM, Heymsfield SB. Advances in digital anthropometric body composition assessment: neural network algorithm prediction of appendicular lean mass. Eur J Clin Nutr. 2024 May;78(5):452-454. doi: 10.1038/s41430-023-01396-3. Epub 2023 Dec 23.
PubMed 38142263McCarthy C, Tinsley GM, Yang S, Irving BA, Wong MC, Bennett JP, Shepherd JA, Heymsfield SB. Smartphone prediction of skeletal muscle mass: model development and validation in adults. Am J Clin Nutr. 2023 Apr;117(4):794-801. doi: 10.1016/j.ajcnut.2023.02.003. Epub 2023 Feb 8.
PubMed 36822238Wong MC, Bennett JP, Leong LT, Tian IY, Liu YE, Kelly NN, McCarthy C, Wong JMW, Ebbeling CB, Ludwig DS, Irving BA, Scott MC, Stampley J, Davis B, Johannsen N, Matthews R, Vincellette C, Garber AK, Maskarinec G, Weiss E, Rood J, Varanoske AN, Pasiakos SM, Heymsfield SB, Shepherd JA. Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry. Am J Clin Nutr. 2023 Apr;117(4):802-813. doi: 10.1016/j.ajcnut.2023.02.006. Epub 2023 Feb 14.
PubMed 36796647
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Skeletal Muscle and Cardiometabolic Health in Older Adults-REALPA Breaks in Sedentary Time Pilot Study
- ClinicalTrials.gov ID
- NCT03771417
- Acronym / sponsor ID
- REALPA / 2018-026
- Conditions
- Aging, Sarcopenia, Disability Physical, Cardiovascular Diseases, Insulin Resistance, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Louisiana State University and A&M CollegeUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center, National Institute on Aging (NIA)
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal muscle health in older adults?
What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal cardiometabolic health in older adults?
Detailed description
Although awareness of the detrimental impact that sedentary behavior has on skeletal muscle and cardiometabolic health has increased over the last 20 years, more than 60% of older adults remain sedentary for greater than 8 hours per day. Moreover, 80% to 90% of adults 60 years of age or older do not meet the current public health guidelines for aerobic exercise (AE) or resistance exercise (RE) based physical activity (PA). Collectively, these adverse health behaviors contribute to the development of multiple chronic medical conditions commonly afflicting older adults, including type 2 diabetes, cardiovascular disease, sarco/dynapenia, frailty, and premature mortality. Emerging evidence suggests that breaking up sedentary time with light intensity PA (LPA) improves muscle and cardiometabolic health. Recent data also suggest that RE combined with moderate intensity AE effectively improves muscle and cardiometabolic health in older adults. However, the impact that RE combined with LPA breaks in sedentary time has on muscle and cardiometabolic health in older adults remains unknown. The overall objective of this pilot study is to determine the effect of 16 weeks of RE alone or RE combined with LPA breaks in sedentary time on muscle and cardiometabolic health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise | Experimental | Behavioral: Exercise InterventionExercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week. |
| RE plus Low Intensity Physical Activity | Experimental | Behavioral: Exercise InterventionExercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week and regular unsupervised low intensity physical activity breaks in sedentary time 5 days per week [6x10 min breaks/d at 2 metabolic equivalents (METS) or ~30-40% peak oxygen consumption (VO2 peak), ~500 kcal/wk above resting metabolism]. |
| RE plus Moderate IntensityExercise | Active comparator | Behavioral: Exercise InterventionExercise Intervention: Participants will be asked to complete supervised RE 2 days per week and supervised calorically matched moderate intensity physical activity 3 days per week (50 min/session at 4 METS (~60-75% VO2 peak), ~500 kcal/week above resting metabolism). |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Are capable and willing to give written informed consent, and understand exclusion criteria
- 65-80 years of age inclusive
- Body Mass Index (BMI) between 18.5-34.9 kg/m2, inclusive
- Physically inactive determined by self-report
- Stable medical therapy for allowable medications for 30 days defined as:
Key exclusion criteria (37 listed)
- Nursing home resident
- Physically Active:
- Saint Louis University Mental State (SLUMS) score < 21
- Evidence or self-report history of deep vein thrombosis, pulmonary embolism, cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease
- Evidence or self-report history of type 1 or 2 diabetes mellitus
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 |
|---|---|---|
| Exercise InterventionThe use of exercise to improve muscle and cardiometabolic health in older adults. | Behavioural | RE plus Low Intensity Physical Activity, RE plus Moderate IntensityExercise, Resistance Exercise |
Primary outcome
Skeletal Muscle Strength
Time frame: Measured at week 0 (baseline) and week 16
The investigators will determine the change from baseline in skeletal muscle strength. These measurements will be performed at baseline and following 16 weeks of exercise training using isokinetic dynamometry and 1 repetition maximum testing.
Skeletal Muscle Mass
Time frame: Measured at week 0 (baseline) and week 16
The investigators will determine the change from baseline in skeletal muscle mass. These measurements will be performed at baseline and following 16 weeks of exercise training using Dual X-Ray Absorptiometry.
1 secondary outcome
Mitochondrial Function
Time frame: Measured at week 0 (baseline) and week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38142263Marazzato F, McCarthy C, Field RH, Nguyen H, Nguyen T, Shepherd JA, Tinsley GM, Heymsfield SB. Advances in digital anthropometric body composition assessment: neural network algorithm prediction of appendicular lean mass. Eur J Clin Nutr. 2024 May;78(5):452-454. doi: 10.1038/s41430-023-01396-3. Epub 2023 Dec 23.
- Derived from this study: PubMed 36822238McCarthy C, Tinsley GM, Yang S, Irving BA, Wong MC, Bennett JP, Shepherd JA, Heymsfield SB. Smartphone prediction of skeletal muscle mass: model development and validation in adults. Am J Clin Nutr. 2023 Apr;117(4):794-801. doi: 10.1016/j.ajcnut.2023.02.003. Epub 2023 Feb 8.
- Derived from this study: PubMed 36796647Wong MC, Bennett JP, Leong LT, Tian IY, Liu YE, Kelly NN, McCarthy C, Wong JMW, Ebbeling CB, Ludwig DS, Irving BA, Scott MC, Stampley J, Davis B, Johannsen N, Matthews R, Vincellette C, Garber AK, Maskarinec G, Weiss E, Rood J, Varanoske AN, Pasiakos SM, Heymsfield SB, Shepherd JA. Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry. Am J Clin Nutr. 2023 Apr;117(4):802-813. doi: 10.1016/j.ajcnut.2023.02.006. Epub 2023 Feb 14.
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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.
Brian Irving, PhD principal investigator
Louisiana State University and A&M College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Aging and Sarcopenia, run by Louisiana State University and A&M College 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 10 inclusion and 37 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 19 Mar 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 19 Mar 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 Strength (time frame: Measured at week 0 (baseline) and week 16). 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?
On the ClinicalTrials.gov record for NCT03771417, which also lists 3 linked publications.
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 19 Mar 2025.