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

Cardiovascular Diseases Clinical Trial

— REALPA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771417
• Other study ID #: 2018-026
• Secondary ID: R21AG058181
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: February 9, 2023

Study information

• Verified date: October 2023
• Source: Louisiana State University and A&M College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 skeletal cardiometabolic health in older adults?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Cardiovascular Diseases
• Diabetes Mellitus
• Disability Physical
• Insulin Resistance
• Sarcopenia

Intervention

Behavioral:
• Exercise Intervention
The use of exercise to improve muscle and cardiometabolic health in older adults.

Locations

Country	Name	City	State
United States	Lousiana State University	Baton Rouge	Louisiana
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Louisiana State University and A&M College	National Institute on Aging (NIA), Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Measured at week 0 (baseline) and week 16
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 and Magnetic Resonance Imaging.	Measured at week 0 (baseline) and week 16
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.	Measured at week 0 (baseline) and week 16