<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/NCT03039556</url>
  </required_header>
  <id_info>
    <org_study_id>0574</org_study_id>
    <nct_id>NCT03039556</nct_id>
  </id_info>
  <brief_title>Step-reduction in Older Men and Women</brief_title>
  <acronym>CDA-SR</acronym>
  <official_title>The Influence of Acute Physical Inactivity on Metabolic Function in Older Men and Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Diabetes Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</source>
  <brief_summary>
    <textblock>
      This study investigates the effects of two weeks of reduced daily ambulation and a subsequent&#xD;
      return to normal physical activity on metabolic health of older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aging results in a progressive loss of muscle mass that is accelerated by periods of muscular&#xD;
      disuse, common for older adults during hospitalization or convalescence from illness.&#xD;
      Transient physical inactivity has been shown to cause muscular atrophy and impairments in&#xD;
      insulin sensitivity in both younger and older adults. However, the recovery capacity of older&#xD;
      adults after such physical inactivity remains unknown. This study aims to determine the&#xD;
      impact of two weeks of daily step reduction to ≤1000 steps per day, an experimental model&#xD;
      mimicking short-term physical inactivity, on glycemic control in older adults and further&#xD;
      investigate whether older adults are able to recover from the consequences of this inactivity&#xD;
      simply by returning to their habitual activity for 14 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Insulin Sensitivity</measure>
    <time_frame>Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)</time_frame>
    <description>Assessed via Matsuda ISI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in lean tissue mass</measure>
    <time_frame>Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)</time_frame>
    <description>Assessed via Dual Energy X-Ray Absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Peak Isometric Maximal Voluntary Leg Extension Strength</measure>
    <time_frame>Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)</time_frame>
    <description>Assessed via muscle dynamometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Protein Synthesis</measure>
    <time_frame>Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)</time_frame>
    <description>Obtained via vastus lateralis muscle biopsy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Older Adults</condition>
  <condition>Reduced Physical Activity</condition>
  <arm_group>
    <arm_group_label>Change in physical activity for older adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Older adult participants undergo alterations in daily ambulation by completing Normal Daily Steps for one week, followed by a two-week Step-Reduction and a subsequent Return to Normal Daily Steps for two weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Normal Daily Steps</intervention_name>
    <description>Complete normal daily ambulation for one week</description>
    <arm_group_label>Change in physical activity for older adults</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Step-Reduction</intervention_name>
    <description>Reduce daily ambulation to fewer than 1000 steps per day for two weeks</description>
    <arm_group_label>Change in physical activity for older adults</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Return to Normal Daily Steps</intervention_name>
    <description>Increase daily ambulation to 100% of normal daily step-count for two weeks</description>
    <arm_group_label>Change in physical activity for older adults</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of assistive walking devices&#xD;
&#xD;
          -  Chronic use of analgesic or anti-inflammatory drugs&#xD;
&#xD;
          -  History of neuromuscular problems or muscle and/or bone wasting disease&#xD;
&#xD;
          -  Acute or chronic illness including cardiac, pulmonary, liver or kidney abnormalities,&#xD;
             uncontrolled hypertension, insulin or non-insulin dependent diabetes or other&#xD;
             metabolic disorders&#xD;
&#xD;
          -  Daily use of statins, particularly simvastatin and atorvastatin&#xD;
&#xD;
          -  Use of medications known to affect protein metabolism&#xD;
&#xD;
          -  Normally complete fewer than 3000 steps per day&#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>
  <location>
    <facility>
      <name>Exercise Metabolism Research Laboratory, McMaster Univeristy</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces &quot;anabolic resistance&quot; of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.</citation>
    <PMID>23589526</PMID>
  </reference>
  <reference>
    <citation>Devries MC, Breen L, Von Allmen M, MacDonald MJ, Moore DR, Offord EA, Horcajada MN, Breuille D, Phillips SM. Low-load resistance training during step-reduction attenuates declines in muscle mass and strength and enhances anabolic sensitivity in older men. Physiol Rep. 2015 Aug;3(8):e12493. doi: 10.14814/phy2.12493.</citation>
    <PMID>26265753</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Stuart Phillips</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03039556
org study id: 0574
nct id: NCT03039556
lead sponsor: 
collaborator: 
This study investigates the effects of two weeks of reduced daily ambulation and a subsequent
      return to normal physical activity on metabolic health of older adults.
Aging results in a progressive loss of muscle mass that is accelerated by periods of muscular
      disuse, common for older adults during hospitalization or convalescence from illness.
      Transient physical inactivity has been shown to cause muscular atrophy and impairments in
      insulin sensitivity in both younger and older adults. However, the recovery capacity of older
      adults after such physical inactivity remains unknown. This study aims to determine the
      impact of two weeks of daily step reduction to ≤1000 steps per day, an experimental model
      mimicking short-term physical inactivity, on glycemic control in older adults and further
      investigate whether older adults are able to recover from the consequences of this inactivity
      simply by returning to their habitual activity for 14 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Insulin Sensitivity
time frame: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)
description: Assessed via Matsuda ISI
measure: Change in lean tissue mass
time frame: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)
description: Assessed via Dual Energy X-Ray Absorptiometry
measure: Change in Peak Isometric Maximal Voluntary Leg Extension Strength
time frame: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)
description: Assessed via muscle dynamometry
measure: Change in Muscle Protein Synthesis
time frame: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)
description: Obtained via vastus lateralis muscle biopsy
arm group label: Change in physical activity for older adults
arm group type: Experimental
description: Older adult participants undergo alterations in daily ambulation by completing Normal Daily Steps for one week, followed by a two-week Step-Reduction and a subsequent Return to Normal Daily Steps for two weeks
intervention type: Behavioral
intervention name: Normal Daily Steps
description: Complete normal daily ambulation for one week
arm group label: Change in physical activity for older adults
intervention type: Behavioral
intervention name: Step-Reduction
description: Reduce daily ambulation to fewer than 1000 steps per day for two weeks
arm group label: Change in physical activity for older adults
intervention type: Behavioral
intervention name: Return to Normal Daily Steps
description: Increase daily ambulation to 100% of normal daily step-count for two weeks
arm group label: Change in physical activity for older adults
criteria: 
gender: All
minimum age: 65 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
citation: Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces "anabolic resistance" of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.
PMID: 23589526
citation: Devries MC, Breen L, Von Allmen M, MacDonald MJ, Moore DR, Offord EA, Horcajada MN, Breuille D, Phillips SM. Low-load resistance training during step-reduction attenuates declines in muscle mass and strength and enhances anabolic sensitivity in older men. Physiol Rep. 2015 Aug;3(8):e12493. doi: 10.14814/phy2.12493.
PMID: 26265753
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Stuart Phillips
investigator title: Professor