Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health (REALPA)

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?

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Diabetes Mellitus; Insulin Resistance; Sarcopenia; Aging; Disability Physical
• Intervention / Treatment: Behavioral: Exercise Intervention

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center
    • Baton Rouge, Louisiana, United States, 70803
      • Lousiana State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Are capable and willing to give written informed consent, and understand exclusion criteria
2. 65-80 years of age inclusive
3. Body Mass Index (BMI) between 18.5-34.9 kg/m2, inclusive
4. Physically inactive determined by self-report

5. Stable medical therapy for allowable medications for 30 days defined as:

   1. No addition or removal of a medication
   2. No change in dosage of a medication
6. Having no life-threatening conditions or diseases
7. 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
8. 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:

1. Nursing home resident

2. Physically Active:

   a. > 100 min/wk of moderate OR > 50 min/wk vigorous intensity PA

3. Saint Louis University Mental State (SLUMS) score < 21
4. Evidence or self-report history of deep vein thrombosis, pulmonary embolism, cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease
5. Evidence or self-report history of type 1 or 2 diabetes mellitus
6. Evidence or self-report history of a bleeding disorder
7. Evidence or self-report history of recurrent vasovagal episodes
8. Evidence or self-report history of severe depression, Schizophrenia, bipolar disease
9. Evidence or self-report history of mobility disability requiring a walker, wheel chair, or inability to walk across a small room.
10. Evidence or self-report history of orthopedic limitations that would preclude them from participation in a dynamic exercise program
11. Evidence or self-report history of severe arthritis (either osteoarthritis or rheumatoid arthritis) that would preclude them from participation in a dynamic exercise program
12. Evidence or self-report of history untreated thyroid dysfunction.
13. Weight loss of > 10% in the last 3 months prior to screening
14. History of weight loss surgery.

15. Use of medications known to influence study outcomes, such as:

    1. Insulin
    2. Oral antidiabetic medications (e.g., metformin)
    3. Corticosteroids
    4. Beta-blockers

    c. Anticoagulants

16. Allergy to lidocaine
17. Active smoking
18. Current consumption of > 14 alcoholic drinks per week based on self-report
19. Regular participation in resistance or aerobic exercise training within 3 months of initial screening

20. Absolute Contraindication to Exercise as Defined by the American College of Sports Medicine,16 including:

    1. Resting diastolic blood pressure > 100 mm Hg
    2. Resting systolic blood pressure > 180 mm Hg
    3. Resting heart rate > 100 beats per min
21. Having a body weight greater than 440 pounds
22. Having medical implants such as a pacemaker or metal joint replacements
23. Having tattoos or permanent makeup completed <30 days prior to the visit
24. Recent (past 3 months) cancer diagnosis, undergoing immunotherapy, taking immune suppressants
25. Presence of allergies or infections requiring antibiotics within the past 14 days
26. Recent (past 3 months) major surgery on the abdomen, pelvis, or lower extremities
27. 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.
28. Evidence or self-report history of severe depression in the last 5 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistance Exercise; Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.	Behavioral: Exercise Intervention; The use of exercise to improve muscle and cardiometabolic health in older adults.
Experimental: 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].	Behavioral: Exercise Intervention; The use of exercise to improve muscle and cardiometabolic health in older adults.
Active Comparator: 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).	Behavioral: Exercise Intervention; The use of exercise to improve muscle and cardiometabolic health in older adults.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Louisiana State University and A&M College
• Collaborators: National Institute on Aging (NIA); Pennington Biomedical Research Center
• Investigators: Principal Investigator: Brian Irving, PhD, Louisiana State University and A&M College

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Actual): February 9, 2023
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: December 7, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Muscular Atrophy; Atrophy; Cardiovascular Diseases; Insulin Resistance; Sarcopenia
• Other Study ID Numbers: 2018-026; R21AG058181 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No