<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/NCT02188849</url>
  </required_header>
  <id_info>
    <org_study_id>Creatine elderly</org_study_id>
    <secondary_id>Creatine INTA</secondary_id>
    <nct_id>NCT02188849</nct_id>
  </id_info>
  <brief_title>Effects of Creatine Supplementation on Muscle Mass and Function Among Older Women Subjected to Resistance Training</brief_title>
  <official_title>Effects of Creatine Supplementation on Muscle Mass and Function Among Older Women Subjected to Resistance Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chile</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine, in a double blind trial, the effects of creatine supplementation during 12&#xD;
      weeks on muscle mass and function of community living older women subjected to resistance&#xD;
      training. Material and methods: Fifty healthy older women will be selected for the study. All&#xD;
      participants will be subjected to a progressive resistance training program using elastic&#xD;
      bands and weights, consisting in three sessions per week lasting 1 hour. Participant will be&#xD;
      randomly allocated in a double blind fashion, to receive creatine 5 g per day or an identical&#xD;
      placebo. The training and supplementation period will last 12 weeks. At baseline and at the&#xD;
      end of the study, body composition will be measured by dual energy x-ray absorptiometry,&#xD;
      rectus femoris cross sectional height and surface will be measured by ultrasound, quadriceps&#xD;
      strength will be measured in a quadriceps table and 12 minutes' walk will be assessed. The&#xD;
      main outcome measure will be quadriceps cross sectional height. Expected results: We expect&#xD;
      that creatine supplementation will increase rectus femoris height over and above the effect&#xD;
      of resistance training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy women of middle and low socioeconomic level, living in the community and aged between&#xD;
      60 and 75 years, will be invited to participate in this study.&#xD;
&#xD;
      At baseline and after signing an informed consent form, the following assessments will be&#xD;
      carried out:&#xD;
&#xD;
        1. A complete medical history including medications, previous diseases and surgical&#xD;
           procedures.&#xD;
&#xD;
        2. Evaluation of usual physical activity using the International Physical Activity&#xD;
           Questionnaire (IPAQ) .&#xD;
&#xD;
        3. Minimental state examination .&#xD;
&#xD;
        4. Mininutritional assessment .&#xD;
&#xD;
        5. Measurement of weight, height, waist and hip circumference.&#xD;
&#xD;
        6. Measurement of body composition by double energy X ray absorptiometry in a General&#xD;
           Electric iDEXA equipment.&#xD;
&#xD;
        7. Measurement of rectus femoris cross sectional height using a General Electric LogiQ&#xD;
           ultrasonographer. Measurements will be made with the participant in supine position and&#xD;
           the tight relaxed. The mid-point between the superior anterior iliac spine and the&#xD;
           superior border to the patella will be the measurement point.&#xD;
&#xD;
        8. Measurement of quadriceps isometric force using a quadriceps table as previously&#xD;
           described .&#xD;
&#xD;
        9. Measurement of hand grip strength using a hand grip dynamometer.&#xD;
&#xD;
       10. Measurement of 12 minutes walking capacity .&#xD;
&#xD;
      After performing the baseline assessment, participants will be randomized in one of two&#xD;
      groups, balancing by age and nutritional status, using a double blind design:&#xD;
&#xD;
        1. The active group will receive creatine 5 g/day in one dose as a powder to be dissolved&#xD;
           in water&#xD;
&#xD;
        2. The control group will receive a placebo of similar aspect and taste as creatine.&#xD;
&#xD;
      The active prescription and the placebo will be identified by a unique numeric code. The&#xD;
      codes will be known by an external professional, not involved in the research. In case of&#xD;
      adverse events, the opening of a specific patient code of a will be requested to this&#xD;
      professional, who will decide the pertinence of the request. Thus, even breaking one code,&#xD;
      the double blind will be maintained for the rest of participants&#xD;
&#xD;
      All participants will be incorporated to an exercise training program, that will last 12&#xD;
      weeks, with three sessions per week. Each exercise session will consist of:&#xD;
&#xD;
        1. A warm-up period of 15 minutes, consisting in walking and cycling in braked bicycle&#xD;
           ergometers.&#xD;
&#xD;
        2. Resistance training of upper and lower limbs, using elastic bands and tubing and free&#xD;
           weights. Training will be calibrated at 60% of one repetition maximum for each muscle&#xD;
           group with three sets of 15 repetitions with one minute rest between each set. All&#xD;
           exercises will be additionally calibrated to be of moderate intensity according to the&#xD;
           Borg scale. The exercise load will be adapted according to the progression of each&#xD;
           participant.&#xD;
&#xD;
        3. An elongation period lasting 10 minutes that will include elongation in mats and&#xD;
           exercise balls.&#xD;
&#xD;
      The attendance of participants to each session, their level of engagement with the exercise&#xD;
      protocol and the overall Borg score will be recorded. All adverse events will be also&#xD;
      recorded following good clinical practice guidelines Every two weeks, a new supply of the&#xD;
      research prescription will be delivered. Participants will be requested to return the unused&#xD;
      sachets to have an approximate assessment of compliance.&#xD;
&#xD;
      At the end of 12 weeks of intervention, all the assessments done at baseline will be&#xD;
      repeated.&#xD;
&#xD;
      All the information of participants will be recorded in encrypted INTERNET databases. Only&#xD;
      researchers will have access to the information, but participants will be informed about the&#xD;
      results of all assessments.&#xD;
&#xD;
      Main outcome measure and calculation of sample size:&#xD;
&#xD;
      The main outcome will be rectus femoris cross sectional height. According to previously&#xD;
      published results, this parameter increases from 20 ± 3.2 to 24.3 ± 3.8 mm after a training&#xD;
      period of 12 weeks . If we expect a 15% difference in rectus femoris cross sectional height&#xD;
      at the end of the intervention period, we would require 19 participants per group to obtain&#xD;
      differences with an α of 0.05 and a power of 0.8- Considering an attrition rate of 30% during&#xD;
      training, we would require 25 participants per group.&#xD;
&#xD;
      Analysis of results:&#xD;
&#xD;
      An intention to treat analysis will be performed. Also a safety analysis will also be carried&#xD;
      out, considering all participants that took at least one dose of creatine or placebo.&#xD;
      According to the normality of variable distribution, parametric or non-parametric tests will&#xD;
      be used to analyze differences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rectus Femoris Cross Sectional Height</measure>
    <time_frame>Twelve weeks</time_frame>
    <description>Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quadriceps Isometric Strength</measure>
    <time_frame>Twelve weeks</time_frame>
    <description>Measurement of quadriceps isometric force using a quadriceps table</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Twelve Minutes Walk</measure>
    <time_frame>Twelve weeks</time_frame>
    <description>Measurement of the distance that a participant can walk during 12 minutes</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Serum Creatinine</measure>
    <time_frame>Twelve weeks</time_frame>
    <description>Serum creatinine levels</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Creatine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Creatine 5 g/ day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin 5 g/day to be dissolved in water</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance exercise training</intervention_name>
    <description>All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.</description>
    <arm_group_label>Creatine</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Creatine</intervention_name>
    <description>Creatine powder 5 g day</description>
    <arm_group_label>Creatine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Absence of a significant disability, defined as the capacity to reach the health&#xD;
             center by their own means with the use of any aid such as canes or wheelchairs&#xD;
&#xD;
          2. Absence of disabling diseases such as cardiac, respiratory, liver or kidney failure or&#xD;
             active cancer&#xD;
&#xD;
          3. Absence of decompensated diabetes mellitus of hypertension. Diabetic patients with&#xD;
             repeated fasting blood glucose levels below 120 mg/dl and a glycosylated hemoglobin&#xD;
             below 7% will be allowed to participate. Hypertensive patients in treatment with a&#xD;
             blood pressure (measured in at least two occasions) below 140/90 mm Hg will also be&#xD;
             allowed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Smoking or excessive consumption of alcohol&#xD;
&#xD;
          2. Use of medications that can cause muscle dysfunction or limit exercise capacity such&#xD;
             as adrenal steroids, chemotherapeutic agents, statins in high doses (ie more than 40&#xD;
             mg/day of atorvastatin) or muscle relaxants.&#xD;
&#xD;
          3. Having a severe osteoarticular disease such as rheumatoid arthritis or severe&#xD;
             osteoarthritis, with precludes participating in an exercise training program.&#xD;
&#xD;
          4. Recent use of ergogenic supplements such as creatine.&#xD;
&#xD;
          5. Being engaged in an active exercise training program.&#xD;
&#xD;
          6. Being illiterate or having a level of cognitive dysfunction that precludes the free&#xD;
             signature of a written informed consent to participate in the study.&#xD;
&#xD;
          7. Any personal or socioeconomic condition that, in opinion of the research team, will&#xD;
             hamper the correct compliance of the participant with the research program.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra Hirsch, MD</last_name>
    <role>Study Director</role>
    <affiliation>INTA University of Chile</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>INTA University of Chile</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitan</state>
        <zip>7830489</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <results_first_submitted>October 1, 2015</results_first_submitted>
  <results_first_submitted_qc>October 1, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 30, 2015</results_first_posted>
  <last_update_submitted>October 1, 2015</last_update_submitted>
  <last_update_submitted_qc>October 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>Daniel Bunout</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>creatine</keyword>
  <keyword>resistance training</keyword>
  <keyword>older women</keyword>
  <keyword>muscle strength</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Creatine</title>
          <description>Creatine 5 g/ day&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.&#xD;
Creatine: Creatine powder 5 g day</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Maltodextrin 5 g/day to be dissolved in water&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Creatine</title>
          <description>Creatine 5 g/ day&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.&#xD;
Creatine: Creatine powder 5 g day</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Maltodextrin 5 g/day to be dissolved in water&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.5" spread="4.5"/>
                    <measurement group_id="B2" value="68.1" spread="4.9"/>
                    <measurement group_id="B3" value="67.8" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Chile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rectus Femoris Cross Sectional Height</title>
        <description>Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound</description>
        <time_frame>Twelve weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Creatine</title>
            <description>Creatine 5 g/ day&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.&#xD;
Creatine: Creatine powder 5 g day</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Maltodextrin 5 g/day to be dissolved in water&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.</description>
          </group>
        </group_list>
        <measure>
          <title>Rectus Femoris Cross Sectional Height</title>
          <description>Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" spread="2.0"/>
                    <measurement group_id="O2" value="17.6" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quadriceps Isometric Strength</title>
        <description>Measurement of quadriceps isometric force using a quadriceps table</description>
        <time_frame>Twelve weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Creatine</title>
            <description>Creatine 5 g/ day&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.&#xD;
Creatine: Creatine powder 5 g day</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Maltodextrin 5 g/day to be dissolved in water&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.</description>
          </group>
        </group_list>
        <measure>
          <title>Quadriceps Isometric Strength</title>
          <description>Measurement of quadriceps isometric force using a quadriceps table</description>
          <units>Newtons</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="278.6" spread="53.9"/>
                    <measurement group_id="O2" value="225.3" spread="50.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Twelve Minutes Walk</title>
        <description>Measurement of the distance that a participant can walk during 12 minutes</description>
        <time_frame>Twelve weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Creatine</title>
            <description>Creatine 5 g/ day&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.&#xD;
Creatine: Creatine powder 5 g day</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Maltodextrin 5 g/day to be dissolved in water&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.</description>
          </group>
        </group_list>
        <measure>
          <title>Twelve Minutes Walk</title>
          <description>Measurement of the distance that a participant can walk during 12 minutes</description>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1091.4" spread="101.1"/>
                    <measurement group_id="O2" value="1087.5" spread="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Serum Creatinine</title>
        <description>Serum creatinine levels</description>
        <time_frame>Twelve weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Creatine</title>
            <description>Creatine 5 g/ day&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.&#xD;
Creatine: Creatine powder 5 g day</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Maltodextrin 5 g/day to be dissolved in water&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Creatinine</title>
          <description>Serum creatinine levels</description>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.12"/>
                    <measurement group_id="O2" value="0.75" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Creatine</title>
          <description>Creatine 5 g/ day&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.&#xD;
Creatine: Creatine powder 5 g day</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Maltodextrin 5 g/day to be dissolved in water&#xD;
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroinftestinal symptoms</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Falls</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sandra Hirsch MD</name_or_title>
      <organization>Institute of Nutrition and Food Technology University of Chile</organization>
      <phone>+56 229781485</phone>
      <email>shirsch@inta.uchile.cl</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02188849
org study id: Creatine elderly
secondary id: Creatine INTA
nct id: NCT02188849
lead sponsor: 
has dmc: Yes
To determine, in a double blind trial, the effects of creatine supplementation during 12
      weeks on muscle mass and function of community living older women subjected to resistance
      training. Material and methods: Fifty healthy older women will be selected for the study. All
      participants will be subjected to a progressive resistance training program using elastic
      bands and weights, consisting in three sessions per week lasting 1 hour. Participant will be
      randomly allocated in a double blind fashion, to receive creatine 5 g per day or an identical
      placebo. The training and supplementation period will last 12 weeks. At baseline and at the
      end of the study, body composition will be measured by dual energy x-ray absorptiometry,
      rectus femoris cross sectional height and surface will be measured by ultrasound, quadriceps
      strength will be measured in a quadriceps table and 12 minutes' walk will be assessed. The
      main outcome measure will be quadriceps cross sectional height. Expected results: We expect
      that creatine supplementation will increase rectus femoris height over and above the effect
      of resistance training.
Healthy women of middle and low socioeconomic level, living in the community and aged between
      60 and 75 years, will be invited to participate in this study.

      At baseline and after signing an informed consent form, the following assessments will be
      carried out:

        1. A complete medical history including medications, previous diseases and surgical
           procedures.

        2. Evaluation of usual physical activity using the International Physical Activity
           Questionnaire (IPAQ) .

        3. Minimental state examination .

        4. Mininutritional assessment .

        5. Measurement of weight, height, waist and hip circumference.

        6. Measurement of body composition by double energy X ray absorptiometry in a General
           Electric iDEXA equipment.

        7. Measurement of rectus femoris cross sectional height using a General Electric LogiQ
           ultrasonographer. Measurements will be made with the participant in supine position and
           the tight relaxed. The mid-point between the superior anterior iliac spine and the
           superior border to the patella will be the measurement point.

        8. Measurement of quadriceps isometric force using a quadriceps table as previously
           described .

        9. Measurement of hand grip strength using a hand grip dynamometer.

       10. Measurement of 12 minutes walking capacity .

      After performing the baseline assessment, participants will be randomized in one of two
      groups, balancing by age and nutritional status, using a double blind design:

        1. The active group will receive creatine 5 g/day in one dose as a powder to be dissolved
           in water

        2. The control group will receive a placebo of similar aspect and taste as creatine.

      The active prescription and the placebo will be identified by a unique numeric code. The
      codes will be known by an external professional, not involved in the research. In case of
      adverse events, the opening of a specific patient code of a will be requested to this
      professional, who will decide the pertinence of the request. Thus, even breaking one code,
      the double blind will be maintained for the rest of participants

      All participants will be incorporated to an exercise training program, that will last 12
      weeks, with three sessions per week. Each exercise session will consist of:

        1. A warm-up period of 15 minutes, consisting in walking and cycling in braked bicycle
           ergometers.

        2. Resistance training of upper and lower limbs, using elastic bands and tubing and free
           weights. Training will be calibrated at 60% of one repetition maximum for each muscle
           group with three sets of 15 repetitions with one minute rest between each set. All
           exercises will be additionally calibrated to be of moderate intensity according to the
           Borg scale. The exercise load will be adapted according to the progression of each
           participant.

        3. An elongation period lasting 10 minutes that will include elongation in mats and
           exercise balls.

      The attendance of participants to each session, their level of engagement with the exercise
      protocol and the overall Borg score will be recorded. All adverse events will be also
      recorded following good clinical practice guidelines Every two weeks, a new supply of the
      research prescription will be delivered. Participants will be requested to return the unused
      sachets to have an approximate assessment of compliance.

      At the end of 12 weeks of intervention, all the assessments done at baseline will be
      repeated.

      All the information of participants will be recorded in encrypted INTERNET databases. Only
      researchers will have access to the information, but participants will be informed about the
      results of all assessments.

      Main outcome measure and calculation of sample size:

      The main outcome will be rectus femoris cross sectional height. According to previously
      published results, this parameter increases from 20 ± 3.2 to 24.3 ± 3.8 mm after a training
      period of 12 weeks . If we expect a 15% difference in rectus femoris cross sectional height
      at the end of the intervention period, we would require 19 participants per group to obtain
      differences with an α of 0.05 and a power of 0.8- Considering an attrition rate of 30% during
      training, we would require 25 participants per group.

      Analysis of results:

      An intention to treat analysis will be performed. Also a safety analysis will also be carried
      out, considering all participants that took at least one dose of creatine or placebo.
      According to the normality of variable distribution, parametric or non-parametric tests will
      be used to analyze differences.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Rectus Femoris Cross Sectional Height
time frame: Twelve weeks
description: Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound
measure: Quadriceps Isometric Strength
time frame: Twelve weeks
description: Measurement of quadriceps isometric force using a quadriceps table
measure: Twelve Minutes Walk
time frame: Twelve weeks
description: Measurement of the distance that a participant can walk during 12 minutes
measure: Serum Creatinine
time frame: Twelve weeks
description: Serum creatinine levels
arm group label: Creatine
arm group type: Experimental
description: Creatine 5 g/ day
arm group label: Placebo
arm group type: Placebo Comparator
description: Maltodextrin 5 g/day to be dissolved in water
intervention type: Other
intervention name: Resistance exercise training
description: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.
arm group label: Creatine
arm group label: Placebo
intervention type: Drug
intervention name: Creatine
description: Creatine powder 5 g day
arm group label: Creatine
criteria: 
gender: Female
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sandra Hirsch, MD
role: Study Director
affiliation: INTA University of Chile
facility: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: University of Chile
investigator full name: Daniel Bunout
investigator title: Medical Doctor
mesh term: Muscle Weakness
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 