<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/NCT02984553</url>
  </required_header>
  <id_info>
    <org_study_id>ACC-01</org_study_id>
    <nct_id>NCT02984553</nct_id>
  </id_info>
  <brief_title>Objective Physical Activity Assesment in Postmenopausal Women</brief_title>
  <official_title>The Use of Lactate Thresholds to Individualize Accelerometer Cut-points and Objectively Assess Physical Activity Levels in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro de Estudios, Investigación y Medicina del Deporte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of the Basque Country (UPV/EHU)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centro de Estudios, Investigación y Medicina del Deporte</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to accurately assess weekly physical activity levels of&#xD;
      postmenopausal women using lactate thresholds to individualize the accelerometer cut-points.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This observational study aims to accurately assess weekly physical activity levels of&#xD;
      postmenopausal women using lactate thresholds to individualize the accelerometer cut-points.&#xD;
&#xD;
      Postmenopausal women will be recruited from local advertisements in public health centers.&#xD;
      Each woman will perfom on different days a progressive discontinuous submaximal&#xD;
      walking-running test and several constant speed tests wearing an accelerometer to identify&#xD;
      the individual lactate threshold (LT), the maximal lactate steady state (MLSS) and the&#xD;
      corresponding accelerometer activity counts/min (cpm). Participants then will wear an&#xD;
      actigraph accelerometer (wGT3X-BT) for seven days.&#xD;
&#xD;
      Linear regression equations will be developed for each participant to determine accelerometer&#xD;
      activity counts for each intensity level: 1) sedentary behaviour (&lt;200 cpm), 2) light&#xD;
      intensity (200 cpm to activity counts at LT), 3) moderate intensity (activity counts between&#xD;
      LT and MLSS) and 4) vigorous intensity (activity counts &gt;MLSS). Physical activity levels will&#xD;
      be measured using both, individualized approach and Sasaki, Jonh and Freedson´s (2011)&#xD;
      absolute cut-points obtained through walking and running activities eliciting 3-6 MET&#xD;
      intensities (2689-6166 cpm), considering it a &quot;moderate&quot; effort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2015</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time spent in moderate-to-vigorous physical activities</measure>
    <time_frame>1 week</time_frame>
    <description>The time spent in moderate-to-vigorous physical activities during a week (The participants have to wear an accelerometer attatched at the hip on an elastic belt for a period of 7 days)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>accelerometer intensity cut-points</measure>
    <time_frame>an average of 1 month</time_frame>
    <description>accelerometer activity counts corresponding to each woman´s lactate thresholds will determine each intensity level (These thresholds are determined on the walking-running tests performed on different days with a minimum of one week in between. These tests are independent, they are performed at constant speed during 20min to determine the highest speed at which the lactate concentration remains in a steady state between the minute 10 and 20 of the test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of vertical acceleration peaks during the day</measure>
    <time_frame>1 week</time_frame>
    <description>raw acceleration data will be measured to describe daily exposure to potentially osteogenic vertical impacts (The participants have to wear an accelerometer attatched at the hip on an elastic belt for a period of 7 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>aerobic fitness</measure>
    <time_frame>an average of 1 month</time_frame>
    <description>determination of the speeds corresponding to the lactate thresolds during the walking-running test</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Maximum Strength</measure>
    <time_frame>1 day</time_frame>
    <description>hand grip, leg and bench press maximum lifted weight (kg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>an average of 1 month</time_frame>
    <description>the heart rate variability response during the walking-running tests and during the weekly physical activity assessment</description>
  </other_outcome>
  <enrollment type="Actual">80</enrollment>
  <condition>Primary Prevention</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Postmenopausal women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 50 and 70 years&#xD;
&#xD;
          -  Surgical or natural menopause (no menstrual periods during at least the last 6 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index less than 39kg/m2 (obesity class III)&#xD;
&#xD;
          -  Osteoporosis&#xD;
&#xD;
          -  Presence of low-trauma fractures or severe arthrosis at hip, knees or feet&#xD;
&#xD;
          -  Functional limitation to walk fast or altered gait patters and instability&#xD;
&#xD;
          -  Presence of any chronic disesase that would impair the cardiovascular (e.g. myocardial&#xD;
             infarction, stroke, chronic heart failure), musculoskeletal (osteoporosis, low-trauma&#xD;
             fractures) and respiratory systems (COPD) or any disease or medication known to affect&#xD;
             bone metabolism (glucocorticoids)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esteban Gorostiaga, Medicine</last_name>
    <role>Study Director</role>
    <affiliation>Centro de Estudios, Investigación y Medicina del Deporte</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Estudios, Investigación y Medicina del Deporte</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Vainionpaa A, Korpelainen R, Vihriala E, Rinta-Paavola A, Leppaluoto J, Jamsa T. Intensity of exercise is associated with bone density change in premenopausal women. Osteoporos Int. 2006;17(3):455-63. doi: 10.1007/s00198-005-0005-x. Epub 2006 Jan 11.</citation>
    <PMID>16404492</PMID>
  </reference>
  <reference>
    <citation>Martyn-St James M, Carroll S. High-intensity resistance training and postmenopausal bone loss: a meta-analysis. Osteoporos Int. 2006;17(8):1225-40. doi: 10.1007/s00198-006-0083-4. Epub 2006 Jun 1.</citation>
    <PMID>16823548</PMID>
  </reference>
  <reference>
    <citation>Borer KT, Fogleman K, Gross M, La New JM, Dengel D. Walking intensity for postmenopausal bone mineral preservation and accrual. Bone. 2007 Oct;41(4):713-21. doi: 10.1016/j.bone.2007.06.009. Epub 2007 Jun 26.</citation>
    <PMID>17686670</PMID>
  </reference>
  <reference>
    <citation>Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998 May;30(5):777-81. doi: 10.1097/00005768-199805000-00021.</citation>
    <PMID>9588623</PMID>
  </reference>
  <reference>
    <citation>Ozemek C, Cochran HL, Strath SJ, Byun W, Kaminsky LA. Estimating relative intensity using individualized accelerometer cutpoints: the importance of fitness level. BMC Med Res Methodol. 2013 Apr 1;13:53. doi: 10.1186/1471-2288-13-53.</citation>
    <PMID>23547769</PMID>
  </reference>
  <reference>
    <citation>Sasaki JE, John D, Freedson PS. Validation and comparison of ActiGraph activity monitors. J Sci Med Sport. 2011 Sep;14(5):411-6. doi: 10.1016/j.jsams.2011.04.003. Epub 2011 May 25.</citation>
    <PMID>21616714</PMID>
  </reference>
  <reference>
    <citation>Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.</citation>
    <PMID>1494764</PMID>
  </reference>
  <reference>
    <citation>Miller NE, Strath SJ, Swartz AM, Cashin SE. Estimating absolute and relative physical activity intensity across age via accelerometry in adults. J Aging Phys Act. 2010 Apr;18(2):158-70. doi: 10.1123/japa.18.2.158.</citation>
    <PMID>20440028</PMID>
  </reference>
  <reference>
    <citation>Lopes VP, Magalhaes P, Bragada J, Vasques C. Actigraph calibration in obese/overweight and type 2 diabetes mellitus middle-aged to old adult patients. J Phys Act Health. 2009;6 Suppl 1:S133-40. doi: 10.1123/jpah.6.s1.s133.</citation>
    <PMID>19998859</PMID>
  </reference>
  <reference>
    <citation>Hannam K, Deere KC, Hartley A, Clark EM, Coulson J, Ireland A, Moss C, Edwards MH, Dennison E, Gaysin T, Cooper R, Wong A, McPhee JS, Cooper C, Kuh D, Tobias JH. A novel accelerometer-based method to describe day-to-day exposure to potentially osteogenic vertical impacts in older adults: findings from a multi-cohort study. Osteoporos Int. 2017 Mar;28(3):1001-1011. doi: 10.1007/s00198-016-3810-5. Epub 2016 Oct 31.</citation>
    <PMID>27798733</PMID>
  </reference>
  <reference>
    <citation>Beneke R. Methodological aspects of maximal lactate steady state-implications for performance testing. Eur J Appl Physiol. 2003 Mar;89(1):95-9. doi: 10.1007/s00421-002-0783-1. Epub 2003 Jan 21.</citation>
    <PMID>12627312</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of the Basque Country (UPV/EHU)</investigator_affiliation>
    <investigator_full_name>Erreka Gil Rey</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>accelerometry</keyword>
  <keyword>aerobic fitness</keyword>
  <keyword>metabolic thresholds</keyword>
  <keyword>moderate to vigorous physical activity</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Codified IPD (personal data not shown, e.g. 321RR) will be shared with the Musculoskeletal Research Unit of the University of Bristol for the deep analysis of the 3th outcome</ipd_description>
  </patient_data>
  <!-- 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/NCT02984553
org study id: ACC-01
nct id: NCT02984553
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to accurately assess weekly physical activity levels of
      postmenopausal women using lactate thresholds to individualize the accelerometer cut-points.
This observational study aims to accurately assess weekly physical activity levels of
      postmenopausal women using lactate thresholds to individualize the accelerometer cut-points.

      Postmenopausal women will be recruited from local advertisements in public health centers.
      Each woman will perfom on different days a progressive discontinuous submaximal
      walking-running test and several constant speed tests wearing an accelerometer to identify
      the individual lactate threshold (LT), the maximal lactate steady state (MLSS) and the
      corresponding accelerometer activity counts/min (cpm). Participants then will wear an
      actigraph accelerometer (wGT3X-BT) for seven days.

      Linear regression equations will be developed for each participant to determine accelerometer
      activity counts for each intensity level: 1) sedentary behaviour (<200 cpm), 2) light
      intensity (200 cpm to activity counts at LT), 3) moderate intensity (activity counts between
      LT and MLSS) and 4) vigorous intensity (activity counts >MLSS). Physical activity levels will
      be measured using both, individualized approach and Sasaki, Jonh and Freedson´s (2011)
      absolute cut-points obtained through walking and running activities eliciting 3-6 MET
      intensities (2689-6166 cpm), considering it a "moderate" effort.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Time spent in moderate-to-vigorous physical activities
time frame: 1 week
description: The time spent in moderate-to-vigorous physical activities during a week (The participants have to wear an accelerometer attatched at the hip on an elastic belt for a period of 7 days)
measure: accelerometer intensity cut-points
time frame: an average of 1 month
description: accelerometer activity counts corresponding to each woman´s lactate thresholds will determine each intensity level (These thresholds are determined on the walking-running tests performed on different days with a minimum of one week in between. These tests are independent, they are performed at constant speed during 20min to determine the highest speed at which the lactate concentration remains in a steady state between the minute 10 and 20 of the test)
measure: Number of vertical acceleration peaks during the day
time frame: 1 week
description: raw acceleration data will be measured to describe daily exposure to potentially osteogenic vertical impacts (The participants have to wear an accelerometer attatched at the hip on an elastic belt for a period of 7 days)
measure: aerobic fitness
time frame: an average of 1 month
description: determination of the speeds corresponding to the lactate thresolds during the walking-running test
measure: Maximum Strength
time frame: 1 day
description: hand grip, leg and bench press maximum lifted weight (kg)
measure: Heart rate variability
time frame: an average of 1 month
description: the heart rate variability response during the walking-running tests and during the weekly physical activity assessment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Esteban Gorostiaga, Medicine
role: Study Director
affiliation: Centro de Estudios, Investigación y Medicina del Deporte
facility: 
country: Spain
citation: Vainionpaa A, Korpelainen R, Vihriala E, Rinta-Paavola A, Leppaluoto J, Jamsa T. Intensity of exercise is associated with bone density change in premenopausal women. Osteoporos Int. 2006;17(3):455-63. doi: 10.1007/s00198-005-0005-x. Epub 2006 Jan 11.
PMID: 16404492
citation: Martyn-St James M, Carroll S. High-intensity resistance training and postmenopausal bone loss: a meta-analysis. Osteoporos Int. 2006;17(8):1225-40. doi: 10.1007/s00198-006-0083-4. Epub 2006 Jun 1.
PMID: 16823548
citation: Borer KT, Fogleman K, Gross M, La New JM, Dengel D. Walking intensity for postmenopausal bone mineral preservation and accrual. Bone. 2007 Oct;41(4):713-21. doi: 10.1016/j.bone.2007.06.009. Epub 2007 Jun 26.
PMID: 17686670
citation: Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998 May;30(5):777-81. doi: 10.1097/00005768-199805000-00021.
PMID: 9588623
citation: Ozemek C, Cochran HL, Strath SJ, Byun W, Kaminsky LA. Estimating relative intensity using individualized accelerometer cutpoints: the importance of fitness level. BMC Med Res Methodol. 2013 Apr 1;13:53. doi: 10.1186/1471-2288-13-53.
PMID: 23547769
citation: Sasaki JE, John D, Freedson PS. Validation and comparison of ActiGraph activity monitors. J Sci Med Sport. 2011 Sep;14(5):411-6. doi: 10.1016/j.jsams.2011.04.003. Epub 2011 May 25.
PMID: 21616714
citation: Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.
PMID: 1494764
citation: Miller NE, Strath SJ, Swartz AM, Cashin SE. Estimating absolute and relative physical activity intensity across age via accelerometry in adults. J Aging Phys Act. 2010 Apr;18(2):158-70. doi: 10.1123/japa.18.2.158.
PMID: 20440028
citation: Lopes VP, Magalhaes P, Bragada J, Vasques C. Actigraph calibration in obese/overweight and type 2 diabetes mellitus middle-aged to old adult patients. J Phys Act Health. 2009;6 Suppl 1:S133-40. doi: 10.1123/jpah.6.s1.s133.
PMID: 19998859
citation: Hannam K, Deere KC, Hartley A, Clark EM, Coulson J, Ireland A, Moss C, Edwards MH, Dennison E, Gaysin T, Cooper R, Wong A, McPhee JS, Cooper C, Kuh D, Tobias JH. A novel accelerometer-based method to describe day-to-day exposure to potentially osteogenic vertical impacts in older adults: findings from a multi-cohort study. Osteoporos Int. 2017 Mar;28(3):1001-1011. doi: 10.1007/s00198-016-3810-5. Epub 2016 Oct 31.
PMID: 27798733
citation: Beneke R. Methodological aspects of maximal lactate steady state-implications for performance testing. Eur J Appl Physiol. 2003 Mar;89(1):95-9. doi: 10.1007/s00421-002-0783-1. Epub 2003 Jan 21.
PMID: 12627312
responsible party type: Principal Investigator
investigator affiliation: University of the Basque Country (UPV/EHU)
investigator full name: Erreka Gil Rey
investigator title: Principal Investigator
sharing ipd: Yes
ipd description: Codified IPD (personal data not shown, e.g. 321RR) will be shared with the Musculoskeletal Research Unit of the University of Bristol for the deep analysis of the 3th outcome