<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/NCT02185157</url>
  </required_header>
  <id_info>
    <org_study_id>ECAGGOMESUFMG -001</org_study_id>
    <secondary_id>CAAE 0448.0.203.000-11</secondary_id>
    <nct_id>NCT02185157</nct_id>
  </id_info>
  <brief_title>Effects of Dual-task Exercises on Gait Parameters and Cognitive Function in Elderly Women: A Randomized Controlled Trial</brief_title>
  <official_title>Effects of Dual-task Versus Aerobic Training on Gait Stride Variability and Cognitive Function of Independent Community-dwelling Elderly Women: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Minas Gerais</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The training of a secondary task while walking, whether it is reasoning activities, memory or&#xD;
      motor tasks, may enhance automation, walking performance, and postural control and, thus,&#xD;
      minimize the risk of falls influenced by the walking patterns variability. However, the&#xD;
      literature is scarce regarding the influence of dual-task training on changes in gait&#xD;
      parameters.&#xD;
&#xD;
      The purpose of this prospective, blinded randomized controlled trial is to compare the short-&#xD;
      and long-term effects of dual-task and aerobic training on gait stride variability and&#xD;
      superior cerebral functions of independent community-dwelling elderly women.&#xD;
&#xD;
      The participants will be randomly allocated into either experimental or control groups.The&#xD;
      experimental group will undertake 50 minutes/day of dual-task training, three times/week over&#xD;
      12 weeks, totaling 36 sessions, whereas the control group will receive the same doses of&#xD;
      aerobic training. At baseline, after 18 and 36 sessions, and 12 weeks after the cessation of&#xD;
      the interventions, researchers blinded to group allocations will collect the outcome&#xD;
      measures.The interventions will be delivered by trained physical therapists.&#xD;
&#xD;
      Primary outcome will include gait stride variability, which will be assessed by a movement&#xD;
      analysis system: the GaitRite® system, during cognitive and motor dual-tasks, at both normal&#xD;
      and fast speeds. Secondary outcome measures will include a battery of global and specific&#xD;
      cognitive function tests.&#xD;
&#xD;
      The findings of this trial may help better understand whether cognitive-motor interventions&#xD;
      with older adults, when compared to traditional aerobic training, would result in greater&#xD;
      improvements in gait under dual-task conditions and lead to improvements in cognitive tasks.&#xD;
      Furthermore, the findings could potentially bring important insights regarding the impacts of&#xD;
      improvements in walking abilities and cognition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Socially speaking, the findings could potentially bring important insights regarding the&#xD;
      impacts of improvements in walking abilities and cognition. If the elderly maintain safe gait&#xD;
      patterns that prevent falls, they could reach self-sustained community participation and&#xD;
      consequently reduce the burden of care on the family and caregivers. Additionally, the public&#xD;
      health system may ultimately receive important positive economic and social impacts. This&#xD;
      clinical trial may be reproduced in research and clinical practice environments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of gait stride variability</measure>
    <time_frame>Baseline, at the sixth week as a intermediary measure, final and three months after the end of the study</time_frame>
    <description>The change in gait stride variability will be measured by a movement analysis system: The GaitRite® system that gives another gait parameters as speed, step width, double support, etc.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes on the Executive function measured by Addenbrooke's Cognitive Examination-Revised (ACE-R)</measure>
    <time_frame>baseline, at the sixth week as a intermediary measure, final and three months after the end of study months later</time_frame>
    <description>This outcome measure will be assessed by the Brazilian version of the Addenbrooke's Cognitive Examination-Revised (ACE-R) that is a global cognitive assessment instrument with high sensitivity and specificity to detect mild dementia and differentiate frontotemporal dementia from Alzheimer's disease. This instrument assess orientation and attention, memory, verbal fluency, language and visual-spatial skills.&#xD;
A maximum score of 100 is calculated from five sub-scores: Orientation and attention (18 points); memory (26 points); verbal fluency (14 points); language (26 points); and visual-spatial skills (16 points) [26]. The validation study of the English version of the ACE-R proposed a cut-off score of 88 points for higher sensitivity (sensitivity 94 %, specificity89 %). A cut-off score of 82 points was proposed for better specificity (specificity: 100 %, sensitivity: 84%), with population-based norms also available for the Brazilian population.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes on Stroop test or the Color-word interference test</measure>
    <time_frame>Baseline,at the sixth week as a intermediary measure, final and three months after the end of the study</time_frame>
    <description>This test consists of two tasks. For the first task, the participants are asked to name, as fast as possible, the color seen in a square with various color circles. Then, the same colors are shown as written words, instead of the circles. However, the colors are printed in an incongruent way, that is, the word is written in red, but the color is yellow and the participant should be able to identify the color, and not read the word. The examiner takes note of the time and the number of mistakes. The Stroop effect is said to be the difference between the time of execution of the first and the second tasks. Both the time, in minutes, and the number of errors will be registered for analyses.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes on Trail making test</measure>
    <time_frame>Baseline, at the sixth week as a intermediary measure, final and three months after the end of the study</time_frame>
    <description>The trail making test is a classic executive function test and several studies have shown the relationships between its scores with gait abilities. Overall, the test assesses the time to execute visual-motor tasks, as a dimension of a cognitive flexibility test.The test includes two parts:The first consists of drawing a simple line that requires that the individual links numbers 1 to 25, consecutively.The second requires the same consecutive number linking, but now have the interference of letters, so that the linkage is made by alternating letters and numbers. It is also a time-measured test and the time, in minutes, to conclude both parts, will be registered for analyses.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Experimental: Dual Task exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dual-task training, includes 18 sessions model of cognitive and 12 motor dual-task exercises model, were administered in groups of four participants in a comfortable environment, without distraction effects. The 50-minute sessions included 30 minutes of motor dual-task exercises, and then, the participants were divided into pairs. The first pair performed free walks during 10 minutes at their maximal speeds, while the other received individual cognitive dual-task training for the same time, and these activities will be exchanged, so that all pairs could walk and receive cognitive training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control intervention: Aerobic training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The same doses of aerobic training, i.e., 50 minutes, was delivered in groups of five participants. Each session will include 10 minutes of warm-up, 30 minutes of aerobic training on an ergometric bicycle at 60 to 80% of the participants' maximum heart rates,and 10 minutes of cool-down exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>dual -task exercises</intervention_name>
    <description>physical exercises sections with gait and a second task like talk answering some questions or making some exercise with the arms.</description>
    <arm_group_label>Experimental: Dual Task exercises</arm_group_label>
    <other_name>physical exercises</other_name>
    <other_name>aerobic training</other_name>
    <other_name>physical activity</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic training</intervention_name>
    <description>The same doses of aerobic training, i.e., 50 minutes, was delivered in groups of five participants. Each session will include 10 minutes of warm-up, 30 minutes of aerobic training on an ergometric bicycle at 60 to 80% of the participants' maximum heart rates,and 10 minutes of cool-down exercises.</description>
    <arm_group_label>Control intervention: Aerobic training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elderly women will be eligible if they are between 69 and 79 years of age, have at&#xD;
             least three years of schooling,have no cognitive deficits, as determined by the scores&#xD;
             on the Mini-Mental State Examination, adjusted for their education levels: ≥23 for&#xD;
             three years, ≥25 for four to seven years, and ≥26 for eight or more years of school.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be excluded if they have neuromusculoskeletal diseases,which could&#xD;
             restrain physical activities or make use of medications, which could interfere with&#xD;
             motor performance and/or memory.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>69 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gisele C. Gomes, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Minas Gerais</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Physical Therapy</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>31270-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://www.ufmg.br</url>
    <description>University</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 6, 2014</last_update_submitted>
  <last_update_submitted_qc>July 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Minas Gerais</investigator_affiliation>
    <investigator_full_name>Gisele de Cássia Gomes</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>elderly</keyword>
  <keyword>dual-task training</keyword>
  <keyword>aerobic training</keyword>
  <keyword>gait</keyword>
  <keyword>cognition</keyword>
  <!-- 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/NCT02185157
org study id: ECAGGOMESUFMG -001
secondary id: CAAE 0448.0.203.000-11
nct id: NCT02185157
lead sponsor: 
has dmc: Yes
The training of a secondary task while walking, whether it is reasoning activities, memory or
      motor tasks, may enhance automation, walking performance, and postural control and, thus,
      minimize the risk of falls influenced by the walking patterns variability. However, the
      literature is scarce regarding the influence of dual-task training on changes in gait
      parameters.

      The purpose of this prospective, blinded randomized controlled trial is to compare the short-
      and long-term effects of dual-task and aerobic training on gait stride variability and
      superior cerebral functions of independent community-dwelling elderly women.

      The participants will be randomly allocated into either experimental or control groups.The
      experimental group will undertake 50 minutes/day of dual-task training, three times/week over
      12 weeks, totaling 36 sessions, whereas the control group will receive the same doses of
      aerobic training. At baseline, after 18 and 36 sessions, and 12 weeks after the cessation of
      the interventions, researchers blinded to group allocations will collect the outcome
      measures.The interventions will be delivered by trained physical therapists.

      Primary outcome will include gait stride variability, which will be assessed by a movement
      analysis system: the GaitRite® system, during cognitive and motor dual-tasks, at both normal
      and fast speeds. Secondary outcome measures will include a battery of global and specific
      cognitive function tests.

      The findings of this trial may help better understand whether cognitive-motor interventions
      with older adults, when compared to traditional aerobic training, would result in greater
      improvements in gait under dual-task conditions and lead to improvements in cognitive tasks.
      Furthermore, the findings could potentially bring important insights regarding the impacts of
      improvements in walking abilities and cognition.
Socially speaking, the findings could potentially bring important insights regarding the
      impacts of improvements in walking abilities and cognition. If the elderly maintain safe gait
      patterns that prevent falls, they could reach self-sustained community participation and
      consequently reduce the burden of care on the family and caregivers. Additionally, the public
      health system may ultimately receive important positive economic and social impacts. This
      clinical trial may be reproduced in research and clinical practice environments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: change of gait stride variability
time frame: Baseline, at the sixth week as a intermediary measure, final and three months after the end of the study
description: The change in gait stride variability will be measured by a movement analysis system: The GaitRite® system that gives another gait parameters as speed, step width, double support, etc.
measure: Changes on the Executive function measured by Addenbrooke's Cognitive Examination-Revised (ACE-R)
time frame: baseline, at the sixth week as a intermediary measure, final and three months after the end of study months later
description: This outcome measure will be assessed by the Brazilian version of the Addenbrooke's Cognitive Examination-Revised (ACE-R) that is a global cognitive assessment instrument with high sensitivity and specificity to detect mild dementia and differentiate frontotemporal dementia from Alzheimer's disease. This instrument assess orientation and attention, memory, verbal fluency, language and visual-spatial skills.
A maximum score of 100 is calculated from five sub-scores: Orientation and attention (18 points); memory (26 points); verbal fluency (14 points); language (26 points); and visual-spatial skills (16 points) [26]. The validation study of the English version of the ACE-R proposed a cut-off score of 88 points for higher sensitivity (sensitivity 94 %, specificity89 %). A cut-off score of 82 points was proposed for better specificity (specificity: 100 %, sensitivity: 84%), with population-based norms also available for the Brazilian population.
measure: Changes on Stroop test or the Color-word interference test
time frame: Baseline,at the sixth week as a intermediary measure, final and three months after the end of the study
description: This test consists of two tasks. For the first task, the participants are asked to name, as fast as possible, the color seen in a square with various color circles. Then, the same colors are shown as written words, instead of the circles. However, the colors are printed in an incongruent way, that is, the word is written in red, but the color is yellow and the participant should be able to identify the color, and not read the word. The examiner takes note of the time and the number of mistakes. The Stroop effect is said to be the difference between the time of execution of the first and the second tasks. Both the time, in minutes, and the number of errors will be registered for analyses.
measure: Changes on Trail making test
time frame: Baseline, at the sixth week as a intermediary measure, final and three months after the end of the study
description: The trail making test is a classic executive function test and several studies have shown the relationships between its scores with gait abilities. Overall, the test assesses the time to execute visual-motor tasks, as a dimension of a cognitive flexibility test.The test includes two parts:The first consists of drawing a simple line that requires that the individual links numbers 1 to 25, consecutively.The second requires the same consecutive number linking, but now have the interference of letters, so that the linkage is made by alternating letters and numbers. It is also a time-measured test and the time, in minutes, to conclude both parts, will be registered for analyses.
arm group label: Experimental: Dual Task exercises
arm group type: Experimental
description: Dual-task training, includes 18 sessions model of cognitive and 12 motor dual-task exercises model, were administered in groups of four participants in a comfortable environment, without distraction effects. The 50-minute sessions included 30 minutes of motor dual-task exercises, and then, the participants were divided into pairs. The first pair performed free walks during 10 minutes at their maximal speeds, while the other received individual cognitive dual-task training for the same time, and these activities will be exchanged, so that all pairs could walk and receive cognitive training.
arm group label: Control intervention: Aerobic training
arm group type: Other
description: The same doses of aerobic training, i.e., 50 minutes, was delivered in groups of five participants. Each session will include 10 minutes of warm-up, 30 minutes of aerobic training on an ergometric bicycle at 60 to 80% of the participants' maximum heart rates,and 10 minutes of cool-down exercises.
intervention type: Other
intervention name: dual -task exercises
description: physical exercises sections with gait and a second task like talk answering some questions or making some exercise with the arms.
arm group label: Experimental: Dual Task exercises
other name: physical exercises
other name: aerobic training
other name: physical activity
intervention type: Other
intervention name: Aerobic training
description: The same doses of aerobic training, i.e., 50 minutes, was delivered in groups of five participants. Each session will include 10 minutes of warm-up, 30 minutes of aerobic training on an ergometric bicycle at 60 to 80% of the participants' maximum heart rates,and 10 minutes of cool-down exercises.
arm group label: Control intervention: Aerobic training
criteria: 
gender: Female
minimum age: 69 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gisele C. Gomes, Master
role: Principal Investigator
affiliation: Federal University of Minas Gerais
facility: 
country: Brazil
url: http://www.ufmg.br
description: University
responsible party type: Principal Investigator
investigator affiliation: Federal University of Minas Gerais
investigator full name: Gisele de Cássia Gomes
investigator title: Professor