xml: <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/NCT06042218</url>
    </required_header>
    <id_info>
      <org_study_id>UALBIO2023/005</org_study_id>
      <nct_id>NCT06042218</nct_id>
    </id_info>
    <brief_title>Xiaxi Program for Back Health</brief_title>
    <official_title>New Back. Analysis of the Acute and Chronic Effects of a Program of Body and Postural Work Through &quot;Xiaxi Aligns Your Health&quot;</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Católica San Antonio de Murcia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Universidad de Almeria</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universidad Católica San Antonio de Murcia</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Progressive deformity from the optimal spinal curvatures is a degenerative disorder related&#xD;
        to progressive ageing that affects an increasing number of adults. This is one of the main&#xD;
        affectations on the health of adults, being its cause multifactorial. That is why a totally&#xD;
        effective intervention has not yet been found that allows obtaining a substantial improvement&#xD;
        in all the adults who suffer from it. However, certain physical programs that include&#xD;
        mind-body work have been effective, but research is limited and the results are inconclusive.&#xD;
        For this reason, this research arises, in which a training protocol has been designed using&#xD;
        an instrument called Xiaxi with which the body-mind work is prioritized.&#xD;
  &#xD;
        The aims of this study were: 1) to evaluate the effects of a 12-weeks Xiaxi® exercise program&#xD;
        on the sagittal spinal disposition and hamstring extensibility of adults, and 2) to determine&#xD;
        whether the weekly training frequency influenced the changes found on sagittal spinal&#xD;
        disposition and hamstring extensibility with Xiaxi® training program.&#xD;
  &#xD;
        The present investigation is composed of two data collections that will be carried out before&#xD;
        and after a twelve-week intervention. Two intervention groups and a control group make up the&#xD;
        sample, with one of the intervention groups attending Xiaxi training once a week and the&#xD;
        other intervention group twice a week. The control group will only attend the measurements,&#xD;
        but will not participate in the intervention.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">September 11, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 8, 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>Other</primary_purpose>
      <masking>Double (Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sagittal spinal curvature in relaxed standing</measure>
      <time_frame>Up to 12 weeks</time_frame>
      <description>The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject in a standing position, adopting the usual and daily position. The unit of measurement will be the same, using the grades achieved.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sagittal spinal curvature in active alignment in standing</measure>
      <time_frame>Up to 12 weeks</time_frame>
      <description>The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject in a standing position, but in this case the subject will be asked to rectify the arrangement of the spine to be as straight as possible. The unit of measurement will be the same, using the grades achieved.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sagittal spinal curvature in relaxed sitting</measure>
      <time_frame>Up to 12 weeks</time_frame>
      <description>The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject in a seated position, maintaining a habitual, everyday position. The unit of measurement will be the same, using the grades achieved.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sagittal spinal curvature during Macrae &amp; Wright test</measure>
      <time_frame>Up to 12 weeks</time_frame>
      <description>The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject performing the Macrae &amp; Wright test, in which the subject will be asked to perform maximum trunk flexion from a seated position. The unit of measurement will be the same, using the grades achieved.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sagittal spinal curvature during sit and reach test.</measure>
      <time_frame>Up to 12 weeks</time_frame>
      <description>The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject performing the sit and reach test, in which the subject will be asked to perform a maximum trunk flexion from a seated position and with the soles of the feet resting on a box, keeping the knees fully extended during the same, to push a ribbon the maximum distance through the box. The unit of measurement will be the degrees of the curvatures of the back, as well as the distance reached in the test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sagittal spinal curvature during toe touch test</measure>
      <time_frame>Up to 12 weeks</time_frame>
      <description>The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject performing the toe touch test. In this test, the subject will be asked to perform a maximum trunk flexion in which he/she will try to reach the maximum possible distance from a standing position on a box. The knees will be kept fully extended during the test and an attempt will be made to reach the feet, and this distance may be exceeded if necessary. The unit of measurement will be the degrees of the curvatures of the back, as well as the distance reached in the test.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Adults</condition>
    <condition>No Sagittal Spine Disposition Disorder</condition>
    <condition>No Surgery on the Spine or the Hamstring</condition>
    <condition>No Specific Treatment for Spinal Pathology</condition>
    <condition>Not Involved in Structured Exercise Programs Before or During the Time of the Study</condition>
    <arm_group>
      <arm_group_label>Experimental group who trained one day a week</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This intervention group will attend a weekly sixty-minute training session with the Xiaxi machine during the twelve weeks of the intervention. The sessions will include flexibility and strength-resistance work, as well as postural awareness.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental group who trained two days a week</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This intervention group will attend two weekly sixty-minute training sessions with the Xiaxi machine during the twelve weeks of the intervention. The sessions will include flexibility and strength-resistance work, as well as postural awareness.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>They will not attend any type of intervention. They will continue to perform their daily activities without intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Xiaxi intervention program</intervention_name>
      <description>The Xiaxi sessions will follow the same structure in both intervention groups. First of all, 8-minute warm-up where the participants will work on: postural awareness; active static stretching of the pectoral, hamstring and psoas muscles; and mobility. The main part will include the following blocks of content during the 12 weeks of intervention (46 minutes will be spent on this part in each session): breathing; mobility; active and dynamic static stretching of the tonic muscles with effects on the spine dynamic; strength of the phasic muscles with effects on the spine dynamic, alternating upper limb, lower limb and core; postural awareness; and passive static stretching of the tonic muscles with effects on the spine dynamic. The cool down will be similar in each session (6 minutes) and will focus on: postural awareness and passive static stretching of the pectoral, hamstring and psoas muscles.</description>
      <arm_group_label>Experimental group who trained one day a week</arm_group_label>
      <arm_group_label>Experimental group who trained two days a week</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adults from 20 to 60 years-old&#xD;
  &#xD;
            -  not have a doctor-diagnosed sagittal spine disposition disorder&#xD;
  &#xD;
            -  not have had surgery on the spine or the hamstring musculature&#xD;
  &#xD;
            -  not being under a specific treatment for spinal pathology&#xD;
  &#xD;
            -  not involve in structured exercise programs before or during the time of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  not being able to complete all the evaluations&#xD;
  &#xD;
            -  for members of the experimental group missing more than 20% of the sessions&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Universidad Católica San Antonio</name>
        <address>
          <city>Murcia</city>
          <zip>30107</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidad de Almeria</investigator_affiliation>
      <investigator_full_name>Raquel Vaquero-Cristóbal</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042218
  org study id: UALBIO2023/005
  nct id: NCT06042218
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Progressive deformity from the optimal spinal curvatures is a degenerative disorder related
        to progressive ageing that affects an increasing number of adults. This is one of the main
        affectations on the health of adults, being its cause multifactorial. That is why a totally
        effective intervention has not yet been found that allows obtaining a substantial improvement
        in all the adults who suffer from it. However, certain physical programs that include
        mind-body work have been effective, but research is limited and the results are inconclusive.
        For this reason, this research arises, in which a training protocol has been designed using
        an instrument called Xiaxi with which the body-mind work is prioritized.
  
        The aims of this study were: 1) to evaluate the effects of a 12-weeks Xiaxi® exercise program
        on the sagittal spinal disposition and hamstring extensibility of adults, and 2) to determine
        whether the weekly training frequency influenced the changes found on sagittal spinal
        disposition and hamstring extensibility with Xiaxi® training program.
  
        The present investigation is composed of two data collections that will be carried out before
        and after a twelve-week intervention. Two intervention groups and a control group make up the
        sample, with one of the intervention groups attending Xiaxi training once a week and the
        other intervention group twice a week. The control group will only attend the measurements,
        but will not participate in the intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Care Provider, Investigator)
  measure: Sagittal spinal curvature in relaxed standing
  time frame: Up to 12 weeks
  description: The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject in a standing position, adopting the usual and daily position. The unit of measurement will be the same, using the grades achieved.
  measure: Sagittal spinal curvature in active alignment in standing
  time frame: Up to 12 weeks
  description: The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject in a standing position, but in this case the subject will be asked to rectify the arrangement of the spine to be as straight as possible. The unit of measurement will be the same, using the grades achieved.
  measure: Sagittal spinal curvature in relaxed sitting
  time frame: Up to 12 weeks
  description: The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject in a seated position, maintaining a habitual, everyday position. The unit of measurement will be the same, using the grades achieved.
  measure: Sagittal spinal curvature during Macrae & Wright test
  time frame: Up to 12 weeks
  description: The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject performing the Macrae & Wright test, in which the subject will be asked to perform maximum trunk flexion from a seated position. The unit of measurement will be the same, using the grades achieved.
  measure: Sagittal spinal curvature during sit and reach test.
  time frame: Up to 12 weeks
  description: The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject performing the sit and reach test, in which the subject will be asked to perform a maximum trunk flexion from a seated position and with the soles of the feet resting on a box, keeping the knees fully extended during the same, to push a ribbon the maximum distance through the box. The unit of measurement will be the degrees of the curvatures of the back, as well as the distance reached in the test.
  measure: Sagittal spinal curvature during toe touch test
  time frame: Up to 12 weeks
  description: The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject performing the toe touch test. In this test, the subject will be asked to perform a maximum trunk flexion in which he/she will try to reach the maximum possible distance from a standing position on a box. The knees will be kept fully extended during the test and an attempt will be made to reach the feet, and this distance may be exceeded if necessary. The unit of measurement will be the degrees of the curvatures of the back, as well as the distance reached in the test.
  arm group label: Experimental group who trained one day a week
  arm group type: Experimental
  description: This intervention group will attend a weekly sixty-minute training session with the Xiaxi machine during the twelve weeks of the intervention. The sessions will include flexibility and strength-resistance work, as well as postural awareness.
  arm group label: Experimental group who trained two days a week
  arm group type: Experimental
  description: This intervention group will attend two weekly sixty-minute training sessions with the Xiaxi machine during the twelve weeks of the intervention. The sessions will include flexibility and strength-resistance work, as well as postural awareness.
  arm group label: Control Group
  arm group type: No Intervention
  description: They will not attend any type of intervention. They will continue to perform their daily activities without intervention.
  intervention type: Behavioral
  intervention name: Xiaxi intervention program
  description: The Xiaxi sessions will follow the same structure in both intervention groups. First of all, 8-minute warm-up where the participants will work on: postural awareness; active static stretching of the pectoral, hamstring and psoas muscles; and mobility. The main part will include the following blocks of content during the 12 weeks of intervention (46 minutes will be spent on this part in each session): breathing; mobility; active and dynamic static stretching of the tonic muscles with effects on the spine dynamic; strength of the phasic muscles with effects on the spine dynamic, alternating upper limb, lower limb and core; postural awareness; and passive static stretching of the tonic muscles with effects on the spine dynamic. The cool down will be similar in each session (6 minutes) and will focus on: postural awareness and passive static stretching of the pectoral, hamstring and psoas muscles.
  arm group label: Experimental group who trained one day a week
  arm group label: Experimental group who trained two days a week
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Universidad de Almeria
  investigator full name: Raquel Vaquero-Cristóbal
  investigator title: Principal Investigator
  sharing ipd: No