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

Primary Purpose

Aging, Sarcopenia, Disability Physical

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
Louisiana State University and A&M College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Lousiana State University
  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Resistance Exercise

RE plus Low Intensity Physical Activity

RE plus Moderate IntensityExercise

Arm Description

Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.

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: 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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 7, 2018
Last Updated
April 26, 2023
Sponsor
Louisiana State University and A&M College
Collaborators
Pennington Biomedical Research Center, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03771417
Brief Title
Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
February 9, 2023 (Actual)
Study Completion Date
February 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University and A&M College
Collaborators
Pennington Biomedical Research Center, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Sarcopenia, Disability Physical, Cardiovascular Diseases, Insulin Resistance, Diabetes Mellitus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance Exercise
Arm Type
Experimental
Arm Description
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.
Arm Title
RE plus Low Intensity Physical Activity
Arm Type
Experimental
Arm Description
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].
Arm Title
RE plus Moderate IntensityExercise
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
The use of exercise to improve muscle and cardiometabolic health in older adults.
Primary Outcome Measure Information:
Title
Skeletal Muscle Strength
Description
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.
Time Frame
Measured at week 0 (baseline) and week 16
Title
Skeletal Muscle Mass
Description
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.
Time Frame
Measured at week 0 (baseline) and week 16
Secondary Outcome Measure Information:
Title
Mitochondrial Function
Description
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.
Time Frame
Measured at week 0 (baseline) and week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: No addition or removal of a medication 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. 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: Insulin Oral antidiabetic medications (e.g., metformin) Corticosteroids Beta-blockers 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Irving, PhD
Organizational Affiliation
Louisiana State University and A&M College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lousiana State University
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70803
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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

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