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/NCT06038500</url>
    </required_header>
    <id_info>
      <org_study_id>R-2019-1310-040</org_study_id>
      <nct_id>NCT06038500</nct_id>
    </id_info>
    <brief_title>Multicomponent Intervention in Women at Risk of Sarcopenia</brief_title>
    <official_title>Effect of an Intervention of Dance, Resistance Exercises and Nutritional Recommendations on Muscle Mass and Strength in Women With Risk of Sarcopenia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Coordinación de Investigación en Salud, Mexico</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Guadalajara</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Universidad de Colima</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Coordinación de Investigación en Salud, Mexico</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>
        The goal of this quasi-experimental pilot study is to evaluate the effect of a&#xD;
        multi-component intervention in women between 55 and 75 years old at risk of sarcopenia. The&#xD;
        main question it aims to answer are: What is the effect of a multi-component intervention in&#xD;
        women at risk of sarcopenia? Participants will twelve women between 55 and 75 years old with&#xD;
        risk of sarcopenia, who agreed through written informed consent for participate 12 weeks with&#xD;
        24 sessions included dancing, resistance exercises, and nutritional education. The outcomes&#xD;
        were muscle mass, grip strength, gait speed and body composition. The effects were measured&#xD;
        before and after the intervention, under a self-controlled design.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The women in our study were recruited by simple random sampling from the database of patients&#xD;
        who regularly attend the climacteric clinic. Participation in the study was requested through&#xD;
        written informed consent. The selection criteria were being a biological woman, aged between&#xD;
        55-75 years, with current public health insurance, preserved physical and mental capacities&#xD;
        (verified through data from the medical record), and meeting the stipulated criteria to&#xD;
        consider probable sarcopenia according to consensus of European Working Group on Sarcopenia&#xD;
        in Older People (EWGSOP). The latter has a lower grip strength of less or equal to 20.99 kg;&#xD;
        appendicular skeletal muscle index (ASMI) maintained, greater than or equal to 5.5 kg/m^2;&#xD;
        and a walking speed of greater than or equal to 0.8 m/s. The exclusion criteria were related&#xD;
        to conditions that could affect: 1) bioelectric activity (osteosynthesis metal systems or&#xD;
        devices, pacemakers, defibrillators), 2) body composition (history of cancer, uncontrolled&#xD;
        chronic degenerative diseases, risk of malnutrition, respiratory insufficiency, asthma or&#xD;
        chronic obstructive pulmonary disease, hospitalization in the year prior to the study;&#xD;
        limitations in carrying out the basic activities of daily living; medical contraindication&#xD;
        for physical activity, and or belonging to another physical activity group).&#xD;
  &#xD;
        The multicomponent intervention program included 24 sessions and was developed over 12 weeks&#xD;
        (two sessions per week), incorporating resistance exercises, dancing sessions, and&#xD;
        nutritional education.&#xD;
  &#xD;
        The resistance exercises consisted of performing four exercises for the upper and lower parts&#xD;
        of the body using low-intensity resistance bands (from 4 to 15 kg) with a length of 1.22 m.&#xD;
        The workload in the first month consisted of two sets of ten repetitions, the second month&#xD;
        four sets of eight repetitions, and the third month four sets of fifteen repetitions.&#xD;
  &#xD;
        Regarding dancing, the styles practiced throughout the program were salsa, merengue, rock &amp;&#xD;
        rock, cumbia, and &quot;cumbia norteña&quot;. It was estimated that each session (dance + resistance&#xD;
        exercise) generated a caloric expenditure of 270.85 calories corresponding to 4.5 and 3.5&#xD;
        METs per activity, according to the Compendium of Physical Activities. The resistance&#xD;
        exercises and the dance sessions began with a warm-up and stretching session (10 min),&#xD;
        followed by the resistance exercises (30 min) and dancing practice (30 min). The session&#xD;
        ended with a cooling down session (10 min).&#xD;
  &#xD;
        The nutritional education offered included weekly topics lasting 20 min, on basic concepts of&#xD;
        nutrition, hydration, carbohydrates, proteins, fats, fiber, dairy, and non-dairy milk,&#xD;
        probiotics and prebiotics, antioxidants, use of sugar and sweeteners, the importance of&#xD;
        calcium and vitamin D, and recommended diet for the maintenance of skeletal muscle mass.&#xD;
        Reinforcement of the topics was carried out through triptychs that were provided throughout&#xD;
        the 12 sessions.&#xD;
  &#xD;
        The total intervention was 12 weeks with 24 sessions, including dancing, resistance&#xD;
        exercises, and nutritional education.&#xD;
  &#xD;
        The outcomes were muscle mass, grip strength, gait speed, and body composition. The effects&#xD;
        were measured before and after the intervention, under a self-controlled design.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 3, 2019</start_date>
    <completion_date type="Actual">September 27, 2019</completion_date>
    <primary_completion_date type="Actual">September 27, 2019</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>
      <intervention_model_description>quasi-experimental Pre-test/Post-test design - pilot</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Grip strength</measure>
      <time_frame>Baseline measurement and final measurement as the end of the 12 weeks of intervention</time_frame>
      <description>Evaluated with the JAMAR Plus+ Patterson Medical® digital dynamometer, using the technique proposed by the American Society of Hand Therapists. It was based on the average among all the attempts done on each hand</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skeletal muscle mass index (SMI)</measure>
      <time_frame>Baseline measurement and final measurement as the end of the 12 weeks of intervention</time_frame>
      <description>Based on the formula validated by Yamada et al (10.3390/ijerph14070809) for multi-frequency devices using the measurements taken with a TANITA MC 780 (ALM = (0.6947 × (Ht^2/Z50)) + (-55.24 × (Z250/Z5)) + (-10,940 × (1/Z50)) + 51.33)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gait speed</measure>
      <time_frame>Baseline measurement and final measurement as the end of the 12 weeks of intervention</time_frame>
      <description>Evaluated with a stopwatch to estimate the time after acceleration and before deceleration for a total distance of 4 meters.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anthropometric measurements</measure>
      <time_frame>Baseline measurement and final measurement as the end of the 12 weeks of intervention</time_frame>
      <description>Height, mid-arm, waist, hip, and calf measurements stipulated by the ISAK protocol</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Polypharmacy</measure>
      <time_frame>Baseline measurement</time_frame>
      <description>Obtained direct information of women about current pharmacological regimen for diseases</description>
    </other_outcome>
    <other_outcome>
      <measure>Comorbidity</measure>
      <time_frame>Baseline measurement</time_frame>
      <description>Obtained direct information of women about diseases assessed using the Charlson index</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">14</enrollment>
    <condition>Sarcopenia</condition>
    <condition>Grip Strength</condition>
    <condition>Gait Speed</condition>
    <condition>Body Composition</condition>
    <arm_group>
      <arm_group_label>Multicomponent Intervention in only one group of women at Risk of Sarcopenia</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Quasi-experimental Pre-test/Post-test design - pilot</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Multicomponent intervention of resistance exercises, dancing sessions and nutritional education</intervention_name>
      <description>The intervention consisted of two sets of ten repetitions of resistance exercises, the second month four sets of eight repetitions, and the third month four sets of fifteen repetitions. It was estimated that each session (dance + resistance exercise) generated a caloric expenditure of 270.85 calories corresponding to 4.5 and 3.5 METs per activity. The resistance exercises and the dance sessions began and with a warm-up and stretching session 10 min, followed by the resistance exercises 30 min and dancing practice 30 min. The session ended with a cooling down session 10 min. The nutritional education offered included weekly topics lasting 20 min, on basic concepts of nutrition and recommended diet for the maintenance of skeletal muscle mass. Reinforcement of the topics was carried out through triptychs that were provided throughout the 12 sessions.</description>
      <arm_group_label>Multicomponent Intervention in only one group of women at Risk of Sarcopenia</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Positive requested through written informed consent&#xD;
  &#xD;
            -  Current public health insurance&#xD;
  &#xD;
            -  Preserved physical and mental capacities (verified through data from the medical&#xD;
               record)&#xD;
  &#xD;
            -  Having a lower grip strength, less or equal to 20.99 kg&#xD;
  &#xD;
            -  Appendicular skeletal muscle index (ASMI) maintained, greater or equal to 5.5 kg/m^2&#xD;
  &#xD;
            -  Walking speed greater or equal to 0.8 m/s&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Bioelectric activity add (osteosynthesis metal systems or devices, pacemakers,&#xD;
               defibrillators)&#xD;
  &#xD;
            -  Alterations of body composition (history of cancer, uncontrolled chronic degenerative&#xD;
               diseases, risk of malnutrition, respiratory insufficiency, asthma or chronic&#xD;
               obstructive pulmonary disease, hospitalization in the year prior to the study;&#xD;
               limitations in carrying out the basic activities of daily living; medical&#xD;
               contraindication for physical activity, and or belonging to another physical activity&#xD;
               group).&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Maria Claudia Espinel-Bermudez</name>
        <address>
          <city>Guadalajara</city>
          <state>Jalisco</state>
          <zip>44340</zip>
          <country>Mexico</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Mexico</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Coordinación de Investigación en Salud, Mexico</investigator_affiliation>
      <investigator_full_name>Maria Claudia Espinel Bermudez</investigator_full_name>
      <investigator_title>PhD in Medical Sciences</investigator_title>
    </responsible_party>
    <keyword>Sarcopenia</keyword>
    <keyword>Multicomponent</keyword>
    <keyword>Aging</keyword>
    <keyword>Preventive</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sarcopenia</mesh_term>
    </condition_browse>
    <!-- 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/NCT06038500
  org study id: R-2019-1310-040
  nct id: NCT06038500
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this quasi-experimental pilot study is to evaluate the effect of a
        multi-component intervention in women between 55 and 75 years old at risk of sarcopenia. The
        main question it aims to answer are: What is the effect of a multi-component intervention in
        women at risk of sarcopenia? Participants will twelve women between 55 and 75 years old with
        risk of sarcopenia, who agreed through written informed consent for participate 12 weeks with
        24 sessions included dancing, resistance exercises, and nutritional education. The outcomes
        were muscle mass, grip strength, gait speed and body composition. The effects were measured
        before and after the intervention, under a self-controlled design.
  The women in our study were recruited by simple random sampling from the database of patients
        who regularly attend the climacteric clinic. Participation in the study was requested through
        written informed consent. The selection criteria were being a biological woman, aged between
        55-75 years, with current public health insurance, preserved physical and mental capacities
        (verified through data from the medical record), and meeting the stipulated criteria to
        consider probable sarcopenia according to consensus of European Working Group on Sarcopenia
        in Older People (EWGSOP). The latter has a lower grip strength of less or equal to 20.99 kg;
        appendicular skeletal muscle index (ASMI) maintained, greater than or equal to 5.5 kg/m^2;
        and a walking speed of greater than or equal to 0.8 m/s. The exclusion criteria were related
        to conditions that could affect: 1) bioelectric activity (osteosynthesis metal systems or
        devices, pacemakers, defibrillators), 2) body composition (history of cancer, uncontrolled
        chronic degenerative diseases, risk of malnutrition, respiratory insufficiency, asthma or
        chronic obstructive pulmonary disease, hospitalization in the year prior to the study;
        limitations in carrying out the basic activities of daily living; medical contraindication
        for physical activity, and or belonging to another physical activity group).
  
        The multicomponent intervention program included 24 sessions and was developed over 12 weeks
        (two sessions per week), incorporating resistance exercises, dancing sessions, and
        nutritional education.
  
        The resistance exercises consisted of performing four exercises for the upper and lower parts
        of the body using low-intensity resistance bands (from 4 to 15 kg) with a length of 1.22 m.
        The workload in the first month consisted of two sets of ten repetitions, the second month
        four sets of eight repetitions, and the third month four sets of fifteen repetitions.
  
        Regarding dancing, the styles practiced throughout the program were salsa, merengue, rock &
        rock, cumbia, and "cumbia norteña". It was estimated that each session (dance + resistance
        exercise) generated a caloric expenditure of 270.85 calories corresponding to 4.5 and 3.5
        METs per activity, according to the Compendium of Physical Activities. The resistance
        exercises and the dance sessions began with a warm-up and stretching session (10 min),
        followed by the resistance exercises (30 min) and dancing practice (30 min). The session
        ended with a cooling down session (10 min).
  
        The nutritional education offered included weekly topics lasting 20 min, on basic concepts of
        nutrition, hydration, carbohydrates, proteins, fats, fiber, dairy, and non-dairy milk,
        probiotics and prebiotics, antioxidants, use of sugar and sweeteners, the importance of
        calcium and vitamin D, and recommended diet for the maintenance of skeletal muscle mass.
        Reinforcement of the topics was carried out through triptychs that were provided throughout
        the 12 sessions.
  
        The total intervention was 12 weeks with 24 sessions, including dancing, resistance
        exercises, and nutritional education.
  
        The outcomes were muscle mass, grip strength, gait speed, and body composition. The effects
        were measured before and after the intervention, under a self-controlled design.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: quasi-experimental Pre-test/Post-test design - pilot
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Grip strength
  time frame: Baseline measurement and final measurement as the end of the 12 weeks of intervention
  description: Evaluated with the JAMAR Plus+ Patterson Medical® digital dynamometer, using the technique proposed by the American Society of Hand Therapists. It was based on the average among all the attempts done on each hand
  measure: Skeletal muscle mass index (SMI)
  time frame: Baseline measurement and final measurement as the end of the 12 weeks of intervention
  description: Based on the formula validated by Yamada et al (10.3390/ijerph14070809) for multi-frequency devices using the measurements taken with a TANITA MC 780 (ALM = (0.6947 × (Ht^2/Z50)) + (-55.24 × (Z250/Z5)) + (-10,940 × (1/Z50)) + 51.33)
  measure: Gait speed
  time frame: Baseline measurement and final measurement as the end of the 12 weeks of intervention
  description: Evaluated with a stopwatch to estimate the time after acceleration and before deceleration for a total distance of 4 meters.
  measure: Anthropometric measurements
  time frame: Baseline measurement and final measurement as the end of the 12 weeks of intervention
  description: Height, mid-arm, waist, hip, and calf measurements stipulated by the ISAK protocol
  measure: Polypharmacy
  time frame: Baseline measurement
  description: Obtained direct information of women about current pharmacological regimen for diseases
  measure: Comorbidity
  time frame: Baseline measurement
  description: Obtained direct information of women about diseases assessed using the Charlson index
  arm group label: Multicomponent Intervention in only one group of women at Risk of Sarcopenia
  arm group type: Experimental
  description: Quasi-experimental Pre-test/Post-test design - pilot
  intervention type: Other
  intervention name: Multicomponent intervention of resistance exercises, dancing sessions and nutritional education
  description: The intervention consisted of two sets of ten repetitions of resistance exercises, the second month four sets of eight repetitions, and the third month four sets of fifteen repetitions. It was estimated that each session (dance + resistance exercise) generated a caloric expenditure of 270.85 calories corresponding to 4.5 and 3.5 METs per activity. The resistance exercises and the dance sessions began and with a warm-up and stretching session 10 min, followed by the resistance exercises 30 min and dancing practice 30 min. The session ended with a cooling down session 10 min. The nutritional education offered included weekly topics lasting 20 min, on basic concepts of nutrition and recommended diet for the maintenance of skeletal muscle mass. Reinforcement of the topics was carried out through triptychs that were provided throughout the 12 sessions.
  arm group label: Multicomponent Intervention in only one group of women at Risk of Sarcopenia
  criteria: 
  gender: Female
  minimum age: 55 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  country: Mexico
  responsible party type: Principal Investigator
  investigator affiliation: Coordinación de Investigación en Salud, Mexico
  investigator full name: Maria Claudia Espinel Bermudez
  investigator title: PhD in Medical Sciences
  mesh term: Sarcopenia