<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03771417</url>
  </required_header>
  <id_info>
    <org_study_id>2018-026</org_study_id>
    <secondary_id>R21AG058181</secondary_id>
    <nct_id>NCT03771417</nct_id>
  </id_info>
  <brief_title>Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health</brief_title>
  <acronym>REALPA</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisiana State University and A&amp;M College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Louisiana State University and A&amp;M College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      What are the effects of resistance exercise (RE) alone or RE plus low intensity physical&#xD;
      activity (LPA) breaks in sedentary time (ST) on skeletal muscle health in older adults?&#xD;
&#xD;
      What are the effects of resistance exercise (RE) alone or RE plus low intensity physical&#xD;
      activity (LPA) breaks in sedentary time (ST) on skeletal cardiometabolic health in older&#xD;
      adults?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although awareness of the detrimental impact that sedentary behavior has on skeletal muscle&#xD;
      and cardiometabolic health has increased over the last 20 years, more than 60% of older&#xD;
      adults remain sedentary for greater than 8 hours per day. Moreover, 80% to 90% of adults 60&#xD;
      years of age or older do not meet the current public health guidelines for aerobic exercise&#xD;
      (AE) or resistance exercise (RE) based physical activity (PA). Collectively, these adverse&#xD;
      health behaviors contribute to the development of multiple chronic medical conditions&#xD;
      commonly afflicting older adults, including type 2 diabetes, cardiovascular disease,&#xD;
      sarco/dynapenia, frailty, and premature mortality. Emerging evidence suggests that breaking&#xD;
      up sedentary time with light intensity PA (LPA) improves muscle and cardiometabolic health.&#xD;
      Recent data also suggest that RE combined with moderate intensity AE effectively improves&#xD;
      muscle and cardiometabolic health in older adults. However, the impact that RE combined with&#xD;
      LPA breaks in sedentary time has on muscle and cardiometabolic health in older adults remains&#xD;
      unknown. The overall objective of this pilot study is to determine the effect of 16 weeks of&#xD;
      RE alone or RE combined with LPA breaks in sedentary time on muscle and cardiometabolic&#xD;
      health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2018</start_date>
  <completion_date type="Actual">February 9, 2023</completion_date>
  <primary_completion_date type="Actual">February 9, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skeletal Muscle Strength</measure>
    <time_frame>Measured at week 0 (baseline) and week 16</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skeletal Muscle Mass</measure>
    <time_frame>Measured at week 0 (baseline) and week 16</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mitochondrial Function</measure>
    <time_frame>Measured at week 0 (baseline) and week 16</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Aging</condition>
  <condition>Sarcopenia</condition>
  <condition>Disability Physical</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Insulin Resistance</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Resistance Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RE plus Low Intensity Physical Activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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].</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RE plus Moderate IntensityExercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>The use of exercise to improve muscle and cardiometabolic health in older adults.</description>
    <arm_group_label>RE plus Low Intensity Physical Activity</arm_group_label>
    <arm_group_label>RE plus Moderate IntensityExercise</arm_group_label>
    <arm_group_label>Resistance Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Are capable and willing to give written informed consent, and understand exclusion&#xD;
             criteria&#xD;
&#xD;
          2. 65-80 years of age inclusive&#xD;
&#xD;
          3. Body Mass Index (BMI) between 18.5-34.9 kg/m2, inclusive&#xD;
&#xD;
          4. Physically inactive determined by self-report&#xD;
&#xD;
          5. Stable medical therapy for allowable medications for 30 days defined as:&#xD;
&#xD;
               1. No addition or removal of a medication&#xD;
&#xD;
               2. No change in dosage of a medication&#xD;
&#xD;
          6. Having no life-threatening conditions or diseases&#xD;
&#xD;
          7. Willing to allow researchers to use data, bio-specimens (blood and muscle tissue), and&#xD;
             images (e.g., magnetic resonance imaging) for research purposes after study&#xD;
             participation is completed&#xD;
&#xD;
          8. At least 2 weeks post-completion of the COVID19 vaccine regimen. a. Acceptable proof&#xD;
             of vaccine includes a completed vaccine card and/or letter from a healthcare provider&#xD;
             indicating the date that the COVID19 vaccine was completed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Nursing home resident&#xD;
&#xD;
          2. Physically Active:&#xD;
&#xD;
             a. &gt; 100 min/wk of moderate OR &gt; 50 min/wk vigorous intensity PA&#xD;
&#xD;
          3. Saint Louis University Mental State (SLUMS) score &lt; 21&#xD;
&#xD;
          4. Evidence or self-report history of deep vein thrombosis, pulmonary embolism,&#xD;
             cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease&#xD;
&#xD;
          5. Evidence or self-report history of type 1 or 2 diabetes mellitus&#xD;
&#xD;
          6. Evidence or self-report history of a bleeding disorder&#xD;
&#xD;
          7. Evidence or self-report history of recurrent vasovagal episodes&#xD;
&#xD;
          8. Evidence or self-report history of severe depression, Schizophrenia, bipolar disease&#xD;
&#xD;
          9. Evidence or self-report history of mobility disability requiring a walker, wheel&#xD;
             chair, or inability to walk across a small room.&#xD;
&#xD;
         10. Evidence or self-report history of orthopedic limitations that would preclude them&#xD;
             from participation in a dynamic exercise program&#xD;
&#xD;
         11. Evidence or self-report history of severe arthritis (either osteoarthritis or&#xD;
             rheumatoid arthritis) that would preclude them from participation in a dynamic&#xD;
             exercise program&#xD;
&#xD;
         12. Evidence or self-report of history untreated thyroid dysfunction.&#xD;
&#xD;
         13. Weight loss of &gt; 10% in the last 3 months prior to screening&#xD;
&#xD;
         14. History of weight loss surgery.&#xD;
&#xD;
         15. Use of medications known to influence study outcomes, such as:&#xD;
&#xD;
               1. Insulin&#xD;
&#xD;
               2. Oral antidiabetic medications (e.g., metformin)&#xD;
&#xD;
               3. Corticosteroids&#xD;
&#xD;
               4. Beta-blockers&#xD;
&#xD;
             c. Anticoagulants&#xD;
&#xD;
         16. Allergy to lidocaine&#xD;
&#xD;
         17. Active smoking&#xD;
&#xD;
         18. Current consumption of &gt; 14 alcoholic drinks per week based on self-report&#xD;
&#xD;
         19. Regular participation in resistance or aerobic exercise training within 3 months of&#xD;
             initial screening&#xD;
&#xD;
         20. Absolute Contraindication to Exercise as Defined by the American College of Sports&#xD;
             Medicine,16 including:&#xD;
&#xD;
               1. Resting diastolic blood pressure &gt; 100 mm Hg&#xD;
&#xD;
               2. Resting systolic blood pressure &gt; 180 mm Hg&#xD;
&#xD;
               3. Resting heart rate &gt; 100 beats per min&#xD;
&#xD;
         21. Having a body weight greater than 440 pounds&#xD;
&#xD;
         22. Having medical implants such as a pacemaker or metal joint replacements&#xD;
&#xD;
         23. Having tattoos or permanent makeup completed &lt;30 days prior to the visit&#xD;
&#xD;
         24. Recent (past 3 months) cancer diagnosis, undergoing immunotherapy, taking immune&#xD;
             suppressants&#xD;
&#xD;
         25. Presence of allergies or infections requiring antibiotics within the past 14 days&#xD;
&#xD;
         26. Recent (past 3 months) major surgery on the abdomen, pelvis, or lower extremities&#xD;
&#xD;
         27. Any other condition that in the judgement of the Principal Investigator and/or the&#xD;
             Medical Director of this protocol may interfere with study participation and adherence&#xD;
             to the protocol.&#xD;
&#xD;
         28. Evidence or self-report history of severe depression in the last 5 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Irving, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Louisiana State University and A&amp;M College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lousiana State University</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louisiana State University and A&amp;M College</investigator_affiliation>
    <investigator_full_name>Brian Irving</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03771417
org study id: 2018-026
secondary id: R21AG058181
nct id: NCT03771417
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Skeletal Muscle Strength
time frame: Measured at week 0 (baseline) and week 16
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.
measure: Skeletal Muscle Mass
time frame: Measured at week 0 (baseline) and week 16
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.
measure: Mitochondrial Function
time frame: Measured at week 0 (baseline) and week 16
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.
arm group label: Resistance Exercise
arm group type: Experimental
description: Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.
arm group label: RE plus Low Intensity Physical Activity
arm group type: Experimental
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 group label: RE plus Moderate IntensityExercise
arm group type: Active Comparator
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: Exercise Intervention
description: The use of exercise to improve muscle and cardiometabolic health in older adults.
arm group label: RE plus Low Intensity Physical Activity
arm group label: RE plus Moderate IntensityExercise
arm group label: Resistance Exercise
criteria: 
gender: All
minimum age: 65 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Brian Irving, PhD
role: Principal Investigator
affiliation: Louisiana State University and A&M College
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Louisiana State University and A&M College
investigator full name: Brian Irving
investigator title: Assistant Professor
mesh term: Sarcopenia
mesh term: Cardiovascular Diseases
mesh term: Insulin Resistance