<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/NCT03258827</url>
  </required_header>
  <id_info>
    <org_study_id>201700238B0</org_study_id>
    <nct_id>NCT03258827</nct_id>
  </id_info>
  <brief_title>Outcome of Exercise With a Towel in Elderly With Sarcopenia</brief_title>
  <official_title>Chang Gung Medical Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      As the proportion of older adults increases, elderly-related issues attract more attention.&#xD;
      Sarcopenia is one of the popular elderly-related issues. Sarcopenia may induce decreased&#xD;
      muscle strength, poor physical activity, even disability and increase rate of hospitalization&#xD;
      and mortality. Therefore, we want to figure out the management for decreasing prevalence of&#xD;
      sarcopenia in older adults. This trial is planned to perform during 2017/08/01~2017/12/31. We&#xD;
      plan to enroll 60 elderlies who are sarcopenia. These patient will be divided into 2 group&#xD;
      randomize. Experimental group will be received a set of exercise, composed by warm-up,&#xD;
      strengthening training with a towel, cold-down, 60 minutes per time, 3 times per week.&#xD;
      Control group will be suggested home-based walking activity. We will evaluate the patient's&#xD;
      functional performance three times, before training, after training, post-training for three&#xD;
      months, respectively. These results will be analyzed by repeated measure ANOVA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As the proportion of older adults increases, elderly-related issues attract more attention.&#xD;
      Sarcopenia is one of the popular elderly-related issues. Skeletal muscle is an important&#xD;
      component for sustaining physical activity and storing protein. Protein of skeletal muscle is&#xD;
      used as energy substrates in cases of starvation or under stress. As being aging, physical&#xD;
      condition degenerates gradually. Older adults usually have multiple chronic diseases. Lesser&#xD;
      physical function results in less physical activity. As a result, more muscle mass would be&#xD;
      lost. In previous study, after the age of 50 year-old, muscle mass decreases 1-2% per year.&#xD;
      The velocity of muscle mass decline increases after the age of 60 year-old. Sarcopenia may&#xD;
      induce decreased muscle strength, poor physical activity, even disability and increase rate&#xD;
      of hospitalization and mortality. Therefore, we want to figure out the management for&#xD;
      decreasing prevalence of sarcopenia in older adults.&#xD;
&#xD;
      Exercise is an important method for preventing sarcopenia. In this study, we intend to design&#xD;
      a set of exercise which is easily performed for older adults and also has preventing muscle&#xD;
      mass loss effect. Towel is an important tool for exercise.&#xD;
&#xD;
      Duration to execute is during 2017/08/01~2017/12/31. We randomize these 60 older adults into&#xD;
      2 groups (experimental group and control group) and there are 30 older adults in each group.&#xD;
      Those older adults are age above 65 year-old, have lower grip strength and slower walking&#xD;
      speed. One assistant who doesn't know which group these older adults belonged to would record&#xD;
      their basic information and is responsible for the evaluation. We will evaluate the older&#xD;
      adults' functional performance three times, before training, after training, post-training&#xD;
      for three months, respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>We randomize these 60 older adults into 2 groups (experimental group and control group) and there are 30 older adults in each group. Those older adults are age above 65 year-old, have lower grip strength and slower walking speed. Experimental group receive this exercise program training, 60 minutes/time, 3 times/week, total duration: 3 months. Home-based program focuses on walking activity at fast speed, 3 times/week, 60 minutes/times, would be assigned for Control group. Total duration is 3 months.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The assistant who doesn't know the group which patients belong to will evaluate the functional performance of the patients three times, such as before training, after training, post-training 3 months.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fat mass</measure>
    <time_frame>Baseline</time_frame>
    <description>Dual-energy X-ray absorptiometry is used for measuring fat mass.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat-free mass</measure>
    <time_frame>Baseline</time_frame>
    <description>Dual-energy X-ray absorptiometry is used for measuring fat-free mass.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone mineral density</measure>
    <time_frame>Baseline</time_frame>
    <description>Dual-energy X-ray absorptiometry is used for measuring bone mineral density.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal grip strength</measure>
    <time_frame>Baseline</time_frame>
    <description>Handgrip dynamometer is used for measuring maximal grip strength.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Walking speed</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants are asked to walk at a comfortable speed to perform 10 meter walk test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed up and go test</measure>
    <time_frame>Baseline</time_frame>
    <description>At first, the participant sits down. Then the participant would be asked to stand up, walk straight for 3 meters, turn around, go back to the chair and sit down. The duration of whole test would be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Times of stand-up and sit-down within 30 seconds</measure>
    <time_frame>Baseline</time_frame>
    <description>The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sit-down within 30 seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>6 minutes walking test</measure>
    <time_frame>Baseline</time_frame>
    <description>At first, the participant sits down for a rest for 10 minutes. The participant would be asked to walk as longer distance as the participant can within 6 minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Berg balance test</measure>
    <time_frame>Baseline</time_frame>
    <description>The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fat mass</measure>
    <time_frame>Change between baseline and 3 month after training</time_frame>
    <description>Dual-energy X-ray absorptiometry is used for measuring fat mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass</measure>
    <time_frame>Change between baseline and 6 month after training</time_frame>
    <description>Dual-energy X-ray absorptiometry is used for measuring fat mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat-free mass</measure>
    <time_frame>Change between baseline and 3 month after training</time_frame>
    <description>Dual-energy X-ray absorptiometry is used for measuring fat-free mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat-free mass</measure>
    <time_frame>Change between baseline and 6 month after training</time_frame>
    <description>Dual-energy X-ray absorptiometry is used for measuring fat-free mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone mineral density</measure>
    <time_frame>Change between baseline and 3 month after training</time_frame>
    <description>Dual-energy X-ray absorptiometry is used for measuring bone mineral density</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone mineral density</measure>
    <time_frame>Change between baseline and 6 month after training</time_frame>
    <description>Dual-energy X-ray absorptiometry is used for measuring bone mineral density</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal grip strength</measure>
    <time_frame>Change between baseline and 3 month after training</time_frame>
    <description>Handgrip dynamometer is used for measuring maximal grip strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal grip strength</measure>
    <time_frame>Change between baseline and 6 month after training</time_frame>
    <description>Handgrip dynamometer is used for measuring maximal grip strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking speed</measure>
    <time_frame>Change between baseline and 3 month after training</time_frame>
    <description>Participants are asked to walk at a comfortable speed to perform 10 meter walk test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking speed</measure>
    <time_frame>Change between baseline and 6 month after training</time_frame>
    <description>Participants are asked to walk at a comfortable speed to perform 10 meter walk test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and go test</measure>
    <time_frame>Change between baseline and 3 month after training</time_frame>
    <description>At first, the participant sits down. Then the participant would be asked to stand up, walk straight for 3 meters, turn around, go back to the chair and sit down. The duration of whole test would be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and go test</measure>
    <time_frame>Change between baseline and 6 month after training</time_frame>
    <description>At first, the participant sits down. Then the participant would be asked to stand up, walk straight for 3 meters, turn around, go back to the chair and sit down. The duration of whole test would be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Times of stand-up and sit-down within 30 seconds</measure>
    <time_frame>Change between baseline and 3 month after training</time_frame>
    <description>The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sitdown within 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Times of stand-up and sit-down within 30 seconds</measure>
    <time_frame>Change between baseline and 6 month after training</time_frame>
    <description>The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sitdown within 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 minutes walking test</measure>
    <time_frame>Change between baseline and 3 month after training</time_frame>
    <description>At first, the participant sits down for a rest for 10 minutes. The participant would be asked to walk as longer distance as the participant can within 6 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 minutes walking test</measure>
    <time_frame>Change between baseline and 6 month after training</time_frame>
    <description>At first, the participant sits down for a rest for 10 minutes. The participant would be asked to walk as longer distance as the participant can within 6 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg balance test</measure>
    <time_frame>Change between baseline and 3 month after training</time_frame>
    <description>The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg balance test</measure>
    <time_frame>Change between baseline and 6 month after training</time_frame>
    <description>The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>Exercise with a towel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There are 30 old adults in this group who receives exercise program with a towel.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home-based exercise</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>There are 30 old adults in this group who is suggested a home-based program focuses on walking activity at fast speed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Exercise with a towel</intervention_name>
    <description>Exercise program composes with warm-up, strengthening exercise, cold-down, 60 minutes/time, 3 times/week. A towel is an important tool for exercise. Total duration of the program is 3 months.</description>
    <arm_group_label>Exercise with a towel</arm_group_label>
    <other_name>Home-based exercise</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Home-based exercise</intervention_name>
    <description>Home-based program focuses on walking activity at fast speed, 3 times/week, 60 minutes/times. The total duration is 3 months.</description>
    <arm_group_label>Home-based exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age above 65 y/o&#xD;
&#xD;
          2. low muscle mass (male&lt;7.0 kg/m2, female&lt;5.4kg/m2, tested by Dual energy X-ray&#xD;
             Absorptiometry)&#xD;
&#xD;
          3. with or without low grip strength (male&lt; 26 kg, female &lt;18 kg)&#xD;
&#xD;
          4. with or without low walk speed (≤ 0.8 m/s).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. cognitive impairment or can't follow order appropriately&#xD;
&#xD;
          2. elderlies with medical problems that they can't perform the exercise program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shui Tseng</last_name>
    <role>Study Chair</role>
    <affiliation>Chang Gung Medical Foundation Institutional Review Board</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wujia Senior Citizens activity Center of Kaohsiung City Government</name>
      <address>
        <city>Kaohsiung</city>
        <zip>830</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>elderly</keyword>
  <keyword>sarcopenia</keyword>
  <keyword>strengthening exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <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/NCT03258827
org study id: 201700238B0
nct id: NCT03258827
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
As the proportion of older adults increases, elderly-related issues attract more attention.
      Sarcopenia is one of the popular elderly-related issues. Sarcopenia may induce decreased
      muscle strength, poor physical activity, even disability and increase rate of hospitalization
      and mortality. Therefore, we want to figure out the management for decreasing prevalence of
      sarcopenia in older adults. This trial is planned to perform during 2017/08/01~2017/12/31. We
      plan to enroll 60 elderlies who are sarcopenia. These patient will be divided into 2 group
      randomize. Experimental group will be received a set of exercise, composed by warm-up,
      strengthening training with a towel, cold-down, 60 minutes per time, 3 times per week.
      Control group will be suggested home-based walking activity. We will evaluate the patient's
      functional performance three times, before training, after training, post-training for three
      months, respectively. These results will be analyzed by repeated measure ANOVA.
As the proportion of older adults increases, elderly-related issues attract more attention.
      Sarcopenia is one of the popular elderly-related issues. Skeletal muscle is an important
      component for sustaining physical activity and storing protein. Protein of skeletal muscle is
      used as energy substrates in cases of starvation or under stress. As being aging, physical
      condition degenerates gradually. Older adults usually have multiple chronic diseases. Lesser
      physical function results in less physical activity. As a result, more muscle mass would be
      lost. In previous study, after the age of 50 year-old, muscle mass decreases 1-2% per year.
      The velocity of muscle mass decline increases after the age of 60 year-old. Sarcopenia may
      induce decreased muscle strength, poor physical activity, even disability and increase rate
      of hospitalization and mortality. Therefore, we want to figure out the management for
      decreasing prevalence of sarcopenia in older adults.

      Exercise is an important method for preventing sarcopenia. In this study, we intend to design
      a set of exercise which is easily performed for older adults and also has preventing muscle
      mass loss effect. Towel is an important tool for exercise.

      Duration to execute is during 2017/08/01~2017/12/31. We randomize these 60 older adults into
      2 groups (experimental group and control group) and there are 30 older adults in each group.
      Those older adults are age above 65 year-old, have lower grip strength and slower walking
      speed. One assistant who doesn't know which group these older adults belonged to would record
      their basic information and is responsible for the evaluation. We will evaluate the older
      adults' functional performance three times, before training, after training, post-training
      for three months, respectively.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: We randomize these 60 older adults into 2 groups (experimental group and control group) and there are 30 older adults in each group. Those older adults are age above 65 year-old, have lower grip strength and slower walking speed. Experimental group receive this exercise program training, 60 minutes/time, 3 times/week, total duration: 3 months. Home-based program focuses on walking activity at fast speed, 3 times/week, 60 minutes/times, would be assigned for Control group. Total duration is 3 months.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The assistant who doesn't know the group which patients belong to will evaluate the functional performance of the patients three times, such as before training, after training, post-training 3 months.
measure: Fat mass
time frame: Baseline
description: Dual-energy X-ray absorptiometry is used for measuring fat mass.
measure: Fat-free mass
time frame: Baseline
description: Dual-energy X-ray absorptiometry is used for measuring fat-free mass.
measure: Bone mineral density
time frame: Baseline
description: Dual-energy X-ray absorptiometry is used for measuring bone mineral density.
measure: Maximal grip strength
time frame: Baseline
description: Handgrip dynamometer is used for measuring maximal grip strength.
measure: Walking speed
time frame: Baseline
description: Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
measure: Timed up and go test
time frame: Baseline
description: At first, the participant sits down. Then the participant would be asked to stand up, walk straight for 3 meters, turn around, go back to the chair and sit down. The duration of whole test would be measured.
measure: Times of stand-up and sit-down within 30 seconds
time frame: Baseline
description: The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sit-down within 30 seconds.
measure: 6 minutes walking test
time frame: Baseline
description: At first, the participant sits down for a rest for 10 minutes. The participant would be asked to walk as longer distance as the participant can within 6 minutes.
measure: Berg balance test
time frame: Baseline
description: The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
measure: Fat mass
time frame: Change between baseline and 3 month after training
description: Dual-energy X-ray absorptiometry is used for measuring fat mass
measure: Fat mass
time frame: Change between baseline and 6 month after training
description: Dual-energy X-ray absorptiometry is used for measuring fat mass
measure: Fat-free mass
time frame: Change between baseline and 3 month after training
description: Dual-energy X-ray absorptiometry is used for measuring fat-free mass
measure: Fat-free mass
time frame: Change between baseline and 6 month after training
description: Dual-energy X-ray absorptiometry is used for measuring fat-free mass
measure: Bone mineral density
time frame: Change between baseline and 3 month after training
description: Dual-energy X-ray absorptiometry is used for measuring bone mineral density
measure: Bone mineral density
time frame: Change between baseline and 6 month after training
description: Dual-energy X-ray absorptiometry is used for measuring bone mineral density
measure: Maximal grip strength
time frame: Change between baseline and 3 month after training
description: Handgrip dynamometer is used for measuring maximal grip strength.
measure: Maximal grip strength
time frame: Change between baseline and 6 month after training
description: Handgrip dynamometer is used for measuring maximal grip strength.
measure: Walking speed
time frame: Change between baseline and 3 month after training
description: Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
measure: Walking speed
time frame: Change between baseline and 6 month after training
description: Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
measure: Timed up and go test
time frame: Change between baseline and 3 month after training
description: At first, the participant sits down. Then the participant would be asked to stand up, walk straight for 3 meters, turn around, go back to the chair and sit down. The duration of whole test would be measured.
measure: Timed up and go test
time frame: Change between baseline and 6 month after training
description: At first, the participant sits down. Then the participant would be asked to stand up, walk straight for 3 meters, turn around, go back to the chair and sit down. The duration of whole test would be measured.
measure: Times of stand-up and sit-down within 30 seconds
time frame: Change between baseline and 3 month after training
description: The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sitdown within 30 seconds.
measure: Times of stand-up and sit-down within 30 seconds
time frame: Change between baseline and 6 month after training
description: The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sitdown within 30 seconds.
measure: 6 minutes walking test
time frame: Change between baseline and 3 month after training
description: At first, the participant sits down for a rest for 10 minutes. The participant would be asked to walk as longer distance as the participant can within 6 minutes.
measure: 6 minutes walking test
time frame: Change between baseline and 6 month after training
description: At first, the participant sits down for a rest for 10 minutes. The participant would be asked to walk as longer distance as the participant can within 6 minutes.
measure: Berg balance test
time frame: Change between baseline and 3 month after training
description: The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
measure: Berg balance test
time frame: Change between baseline and 6 month after training
description: The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
arm group label: Exercise with a towel
arm group type: Experimental
description: There are 30 old adults in this group who receives exercise program with a towel.
arm group label: Home-based exercise
arm group type: Placebo Comparator
description: There are 30 old adults in this group who is suggested a home-based program focuses on walking activity at fast speed.
intervention type: Procedure
intervention name: Exercise with a towel
description: Exercise program composes with warm-up, strengthening exercise, cold-down, 60 minutes/time, 3 times/week. A towel is an important tool for exercise. Total duration of the program is 3 months.
arm group label: Exercise with a towel
other name: Home-based exercise
intervention type: Procedure
intervention name: Home-based exercise
description: Home-based program focuses on walking activity at fast speed, 3 times/week, 60 minutes/times. The total duration is 3 months.
arm group label: Home-based exercise
criteria: 
gender: All
minimum age: 65 Years
maximum age: 85 Years
healthy volunteers: No
last name: Shui Tseng
role: Study Chair
affiliation: Chang Gung Medical Foundation Institutional Review Board
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Sarcopenia
sharing ipd: No