<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/NCT02974452</url>
  </required_header>
  <id_info>
    <org_study_id>UAlcalaH</org_study_id>
    <nct_id>NCT02974452</nct_id>
  </id_info>
  <brief_title>Age-related Changes of Shoulder Muscles</brief_title>
  <acronym>SEMG</acronym>
  <official_title>Age-related Changes in Activation Patterns of Shoulder Muscles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alcala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alcala</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A cross-sectional descriptive study, in which the surface electromyographic activity of five&#xD;
      shoulder muscles was compared in three populations: older adults, middle-aged adults and&#xD;
      young adults. The evaluation of the electromyographic data offers a suitable foundation to&#xD;
      understand aging process.&#xD;
&#xD;
      This supports that surface electromyography provide information about the aged shoulder&#xD;
      muscles. Loss of functionality is suffered by a high percentage of older adults, which&#xD;
      greatly limits their physical activity. In this sense, this paper presents findings that&#xD;
      might be related with possible therapeutic approaches in subsequent studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the present work was to assess neuromotor abnormalities in aging shoulder.&#xD;
      Twenty young adults (20-42), 20 middle-aged adults (43-67) and 20older adults (&gt;68) were&#xD;
      recruited. A comparative electromyography (EMG) study was performed on the upper and lower&#xD;
      trapezius, middle deltoid, infraspinatus and serratus anterior. The EMG measurement (root&#xD;
      mean square (RMS)) and onset time of isometric contractions were analyzed. Body mass index&#xD;
      and strength were also tested.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The mean Root Mean Square (RMS) value</measure>
    <time_frame>30 minutes</time_frame>
    <description>The electromyographic data were captured simultaneously on a PC by using the LabChart® software. Within the time interval from 2 to 4 seconds after contraction initiation a power spectrum analysis was performed together with the determination of RMS values. The mean RMS values were automatically obtained from the software</description>
  </primary_outcome>
  <primary_outcome>
    <measure>onset latency</measure>
    <time_frame>30 minutes</time_frame>
    <description>Start of contraction on the basis of 15% of RMS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>maximal isometric voluntary contraction</measure>
    <time_frame>5 minutes</time_frame>
    <description>Using hand-held dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body mass index</measure>
    <time_frame>5 minutes</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Electromyography</condition>
  <arm_group>
    <arm_group_label>Group I: Older adults</arm_group_label>
    <description>healthy subjects older than 68 years old whose shoulder muscle are measured by surface electromyography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II: Adults</arm_group_label>
    <description>healthy subjects 43 to 67 years old, whose shoulder muscle are measured by surface electromyography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III: Young adults</arm_group_label>
    <description>healthy subjects 20 to 42 years old, whose shoulder muscle are measured by surface electromyography</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants came from Madrid and Castilla La Mancha (Spain) and voluntarily attended the&#xD;
        Unit of the Research Group &quot;Physical Therapy in Women´s Health Processes&quot; in the Department&#xD;
        of Physical Therapy, University of Alcalá, and the Ocaña Senior Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects with no previously manifested symptoms in the shoulder joint and/or&#xD;
             the neck during the past year,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  moderate or severe cognitive impairment, rheumatologic diseases, massive&#xD;
             osteoarthritis, tumors, shoulder joint instability, circulatory disorders (hemophilia&#xD;
             clotting problems) and dermatological problems exacerbated by contact with skin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Tommes Lacomba, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Alcalá</affiliation>
  </overall_official>
  <results_reference>
    <citation>Lirio Romero C, Torres Lacomba M, Castilla Montoro Y, Prieto Merino D, Pacheco da Costa S, Velasco Marchante MJ, Bodes Pardo G. Mobilization With Movement for Shoulder Dysfunction in Older Adults: A Pilot Trial. J Chiropr Med. 2015 Dec;14(4):249-58. doi: 10.1016/j.jcm.2015.03.001. Epub 2015 Nov 24.</citation>
    <PMID>26793036</PMID>
  </results_reference>
  <results_reference>
    <citation>Phadke V, Camargo P, Ludewig P. Scapular and rotator cuff muscle activity during arm elevation: A review of normal function and alterations with shoulder impingement. Rev Bras Fisioter. 2009 Feb 1;13(1):1-9. doi: 10.1590/S1413-35552009005000012.</citation>
    <PMID>20411160</PMID>
  </results_reference>
  <results_reference>
    <citation>Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.</citation>
    <PMID>11018445</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Cristina Lirio Romero</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02974452
org study id: UAlcalaH
nct id: NCT02974452
lead sponsor: 
has dmc: Yes
A cross-sectional descriptive study, in which the surface electromyographic activity of five
      shoulder muscles was compared in three populations: older adults, middle-aged adults and
      young adults. The evaluation of the electromyographic data offers a suitable foundation to
      understand aging process.

      This supports that surface electromyography provide information about the aged shoulder
      muscles. Loss of functionality is suffered by a high percentage of older adults, which
      greatly limits their physical activity. In this sense, this paper presents findings that
      might be related with possible therapeutic approaches in subsequent studies.
The purpose of the present work was to assess neuromotor abnormalities in aging shoulder.
      Twenty young adults (20-42), 20 middle-aged adults (43-67) and 20older adults (>68) were
      recruited. A comparative electromyography (EMG) study was performed on the upper and lower
      trapezius, middle deltoid, infraspinatus and serratus anterior. The EMG measurement (root
      mean square (RMS)) and onset time of isometric contractions were analyzed. Body mass index
      and strength were also tested.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: The mean Root Mean Square (RMS) value
time frame: 30 minutes
description: The electromyographic data were captured simultaneously on a PC by using the LabChart® software. Within the time interval from 2 to 4 seconds after contraction initiation a power spectrum analysis was performed together with the determination of RMS values. The mean RMS values were automatically obtained from the software
measure: onset latency
time frame: 30 minutes
description: Start of contraction on the basis of 15% of RMS
measure: maximal isometric voluntary contraction
time frame: 5 minutes
description: Using hand-held dynamometer
measure: body mass index
time frame: 5 minutes
arm group label: Group I: Older adults
description: healthy subjects older than 68 years old whose shoulder muscle are measured by surface electromyography
arm group label: Group II: Adults
description: healthy subjects 43 to 67 years old, whose shoulder muscle are measured by surface electromyography
arm group label: Group III: Young adults
description: healthy subjects 20 to 42 years old, whose shoulder muscle are measured by surface electromyography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Tommes Lacomba, PhD
role: Study Director
affiliation: University of Alcalá
citation: Lirio Romero C, Torres Lacomba M, Castilla Montoro Y, Prieto Merino D, Pacheco da Costa S, Velasco Marchante MJ, Bodes Pardo G. Mobilization With Movement for Shoulder Dysfunction in Older Adults: A Pilot Trial. J Chiropr Med. 2015 Dec;14(4):249-58. doi: 10.1016/j.jcm.2015.03.001. Epub 2015 Nov 24.
PMID: 26793036
citation: Phadke V, Camargo P, Ludewig P. Scapular and rotator cuff muscle activity during arm elevation: A review of normal function and alterations with shoulder impingement. Rev Bras Fisioter. 2009 Feb 1;13(1):1-9. doi: 10.1590/S1413-35552009005000012.
PMID: 20411160
citation: Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
PMID: 11018445
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Cristina Lirio Romero
investigator title: Physiotherapist
sharing ipd: No