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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG058181 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| Pennington Biomedical Research Center | OTHER |
| National Institute on Aging (NIA) | NIH |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistance Exercise | Experimental | Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week. |
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| 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]. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | The use of exercise to improve muscle and cardiometabolic health in older adults. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 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 at week 0 (baseline) and week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at week 0 (baseline) and week 16 |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
Nursing home resident
Physically Active:
a. > 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
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:
c. 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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Brian Irving, PhD | Louisiana State University and A&M College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lousiana State University | Baton Rouge | Louisiana | 70803 | United States | ||
| Pennington Biomedical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38142263 | Derived | 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. | |
| 36822238 | Derived | McCarthy 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. |
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24 participants were enrolled in the present study, 23 participants were randomized. 1 participant did not complete baseline testing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Resistance Exercise | Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week. Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults. |
| FG001 | RE Plus Low Intensity Physical Activity |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Apr 30, 2021 |
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| Baton Rouge |
| Louisiana |
| 70808 |
| United States |
| 36796647 | Derived | Wong 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. |
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]. Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults. |
| FG002 | RE Plus Moderate Intensity Exercise | 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). Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults. |
| COMPLETED |
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| NOT COMPLETED |
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One participant in the resistance training group withdrew from the study due to time conflict, and one participant in the RE plus Low Intensity Physical Activity was lost to follow-up due to shutdown of campus during the beginning of the covid 19 pandemic.
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| ID | Title | Description |
|---|---|---|
| BG000 | Resistance Exercise | Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week. Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults. |
| BG001 | RE Plus Low Intensity Physical Activity | 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]. Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults. |
| BG002 | RE Plus Moderate IntensityExercise | 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). Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 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. | Change is Leg Press 1-RM | Posted | Mean | Standard Error | Change in Lbs | Measured at week 0 (baseline) and week 16 |
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| Primary | 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. | Change Appendicular Lean Mass (kg/m^2) | Posted | Mean | Standard Error | Change Appendicular Lean Mass (kg/m^2) | Measured at week 0 (baseline) and week 16 |
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| Secondary | 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. | Change skeletal muscle oxidative capacity measured using high-resolution respirometry in permeabilized muscle fibers for complex I and II substrates (pyruvate, malate, glutamate, and succinate) expressed as pmols/sec/mg wet weight. | Posted | Least Squares Mean | Standard Error | pmols/sec/mg wet weight | Measured at week 0 (baseline) and week 16 |
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During study period, up to 16 weeks
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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 | Resistance Exercise | Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week. Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG001 | RE Plus Moderate Intensity Exercise | 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). Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | RE Plus Low Intensity Physical Activity | 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]. Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults. | 0 | 8 | 0 | 8 | 2 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Investigations | Non-systematic Assessment | One participant fell during a study visit. |
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| Vasovagal | Cardiac disorders | Non-systematic Assessment | One participant experienced a vasovagal syncope episode during one of their strength assessments. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian A. Irving, PhD | Louisiana State University | 12255787179 | brianairving@lsu.edu |
| Jan 8, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| RE Plus Moderate IntensityExercise |
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). Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults. |
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