<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/NCT01691131</url>
  </required_header>
  <id_info>
    <org_study_id>Unopar</org_study_id>
    <nct_id>NCT01691131</nct_id>
  </id_info>
  <brief_title>Effects of Two Training Protocols in Patients With Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Effects of Two Training Protocols in Physical Activity in Daily Life and Balance in Patients With COPD: Land Versus Water</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Norte do Paraná</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Norte do Paraná</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: There is evidence that demonstrate the beneficial effects of pulmonary&#xD;
      rehabilitation programs (PR) on symptoms, exercise capacity, muscle strength and quality of&#xD;
      life in patients with Chronic obstructive pulmonary disease (COPD). The majority of the&#xD;
      studies used high intensity endurance and strength exercise training on land. Exercise on&#xD;
      water is an effective form of training that has been used for decades for rehabilitation in&#xD;
      different chronic conditions. In addition, there are promising preliminary results on the&#xD;
      literature regarding aquatic training in patients with COPD. However, several gaps remain.&#xD;
&#xD;
      Aim: Compare the effects of two rehabilitation programs with 6 months of duration in patients&#xD;
      with COPD on physical activity in daily life and balance: land versus water.&#xD;
&#xD;
      Methods: The sample will consist of 36 patients with COPD diagnosed according to the GOLD&#xD;
      criteria, 50 years old or more and clinically stable.&#xD;
&#xD;
      Patients will be evaluated in 3 different moments: before the PR, after the PR and 6 months&#xD;
      after the end of the PR (follow up). In addition to the assessment of physical activity in&#xD;
      daily life and balance, the investigators will also evaluate pulmonary function, peripheral&#xD;
      and respiratory muscle strength, body composition, maximal and submaximal exercise capacity,&#xD;
      functional status and quality of life.&#xD;
&#xD;
      Both groups (land or water) will be submitted for 3 sessions of exercise training per week,&#xD;
      with 45 minutes of duration, during 6 months. The sessions of both groups include the same&#xD;
      exercises sequence. Endurance exercise training will be performed on a bicycle and walking on&#xD;
      land and strength training using free weights. Workload will be established according to the&#xD;
      tests performance on assessment and progression will follow a predetermined schedule and&#xD;
      adjusted according symptoms. On water the same approach will be followed.&#xD;
&#xD;
      Expected results: the investigators expect improvement in terms of symptoms, exercise&#xD;
      capacity, muscle strength, quality of life, functional status and physical activity in daily&#xD;
      life at the end of the two training protocols. However, it is unclear whether one training&#xD;
      protocol will be superior than the other. Due to the characteristics involved in the aquatic&#xD;
      training, the investigators hypothesized that this type of training can result in better&#xD;
      results on balance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is evidence that demonstrate the beneficial effects of pulmonary rehabilitation&#xD;
      programs (PR) on symptoms, exercise capacity, muscle strength and quality of life in patients&#xD;
      with Chronic obstructive pulmonary disease (COPD). The majority of the studies used high&#xD;
      intensity endurance and strength exercise training on land. Exercise on water is an effective&#xD;
      form of training that has been used for decades for rehabilitation in different chronic&#xD;
      conditions. In addition, there are promising preliminary results on the literature regarding&#xD;
      aquatic training in patients with COPD. However, several gaps remain.&#xD;
&#xD;
      Therefore, we aim to compare the effects of two rehabilitation programs with 6 months of&#xD;
      duration in patients with COPD on physical activity in daily life and balance: land versus&#xD;
      water.&#xD;
&#xD;
      The sample will consist of 36 patients with COPD diagnosed according to the GOLD criteria, 50&#xD;
      years old or more and clinically stable.&#xD;
&#xD;
      Patients will be evaluated in 3 different moments: before the PR, after the PR and 6 months&#xD;
      after the end of the PR (follow up). In addition to the assessment of physical activity in&#xD;
      daily life and balance, the investigators will also evaluate pulmonary function, peripheral&#xD;
      and respiratory muscle strength, body composition, maximal and submaximal exercise capacity,&#xD;
      functional status and quality of life.&#xD;
&#xD;
      Both groups (land or water) will be submitted for 3 sessions of exercise training per week,&#xD;
      with 45 minutes of duration, during 6 months. The sessions of both groups include the same&#xD;
      exercises sequence. Endurance exercise training will be performed on a bicycle and walking on&#xD;
      land and strength training using free weights. Workload will be established according to the&#xD;
      tests performance on assessment and progression will follow a predetermined schedule and&#xD;
      adjusted according symptoms. On water the same approach will be followed.&#xD;
&#xD;
      Expected results: the investigators expect improvement in terms of symptoms, exercise&#xD;
      capacity, muscle strength, quality of life, functional status and physical activity in daily&#xD;
      life at the end of the two training protocols. However, it is unclear whether one training&#xD;
      protocol will be superior than the other. Due to the characteristics involved in the aquatic&#xD;
      training, the investigators hypothesized that this type of training can result in better&#xD;
      results on balance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity in daily life (measuremet unit: number of steps per day)</measure>
    <time_frame>four years</time_frame>
    <description>The objectively assessed level of physical activity in daily life will be monitored using the activity monitor Power Walker PW 610 (Yamax, Japan). This device is validated in patients with COPD and the main variables are the number of steps per day and estimation of daily energy expenditure. The monitor will be individually set taking into consideration body weight and step length (measured in a 10-meter walking at usual speed). Patients will wear the device 12 hours per day during 6 days, and the average of these six days will be used for analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Static Balance (Center of Pressure Area in cm2)</measure>
    <time_frame>four years</time_frame>
    <description>Static balance will be evaluated using a force platform (BIOMEC400, EMG System of Brazil, Brazil), which is a reliable instrument for stabilographic measures in both, older and young adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic Balance (Timed up and go test in seconds)</measure>
    <time_frame>four years</time_frame>
    <description>Dynamic balance will be assessed by Timed up and go test (TUG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise capacity (6MWT: distance covered in meters; ISWT: distance covered in meters)</measure>
    <time_frame>four years</time_frame>
    <description>The 6-minute walking test (6MWT) will be performed to verify functional exercise capacity and the Incremental shuttle walk test (ISWT) to assess maximal exercise capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (CRDQ: score in points)</measure>
    <time_frame>four years</time_frame>
    <description>The Chronic Respiratory Disease Questionnaire (CRDQ) will be applied to assess quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional status (LCADL: score in points)</measure>
    <time_frame>four years</time_frame>
    <description>Functional status will be assessed by using the questionnaire &quot;London Chest Activity of Daily Living scale&quot; (LCADL). A total score is calculated according to the patient report for each domain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Exercise training on land</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>High intensity exercise training on land.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise training on water</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>High intensity exercise training on water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise training</intervention_name>
    <description>Comparison of high intensity exercise training on land versus water.</description>
    <arm_group_label>Exercise training on land</arm_group_label>
    <arm_group_label>Exercise training on water</arm_group_label>
    <other_name>Exercise training on land;</other_name>
    <other_name>Exercise training on water.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD diagnosis (according to the GOLD criteria);&#xD;
&#xD;
          -  Stable condition, no exacerbations or infections in the last 3 months;&#xD;
&#xD;
          -  No severe or unstable heart disease;&#xD;
&#xD;
          -  No other pathological conditions that could influence the training performance;&#xD;
&#xD;
          -  Not have participated in other rehabilitation programs in the last six months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Occurrence of acute exacerbation during the evaluation period;&#xD;
&#xD;
          -  Not understanding or non-cooperation regarding the procedures and research methods;&#xD;
&#xD;
          -  Option of the participant to leave the study for any reason;&#xD;
&#xD;
          -  Presence of vestibular disorders (BPPV, labyrinthitis, among others).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabio Pitta, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidade Estadual de Londrina</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vanessa S. Probst, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Norte do Paraná</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Norte do Paraná</name>
      <address>
        <city>Londrina</city>
        <state>Paraná</state>
        <zip>86041-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>April 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity in daily life</keyword>
  <keyword>Balance</keyword>
  <keyword>COPD</keyword>
  <keyword>Exercise training</keyword>
  <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/NCT01691131
org study id: Unopar
nct id: NCT01691131
lead sponsor: 
has dmc: No
Introduction: There is evidence that demonstrate the beneficial effects of pulmonary
      rehabilitation programs (PR) on symptoms, exercise capacity, muscle strength and quality of
      life in patients with Chronic obstructive pulmonary disease (COPD). The majority of the
      studies used high intensity endurance and strength exercise training on land. Exercise on
      water is an effective form of training that has been used for decades for rehabilitation in
      different chronic conditions. In addition, there are promising preliminary results on the
      literature regarding aquatic training in patients with COPD. However, several gaps remain.

      Aim: Compare the effects of two rehabilitation programs with 6 months of duration in patients
      with COPD on physical activity in daily life and balance: land versus water.

      Methods: The sample will consist of 36 patients with COPD diagnosed according to the GOLD
      criteria, 50 years old or more and clinically stable.

      Patients will be evaluated in 3 different moments: before the PR, after the PR and 6 months
      after the end of the PR (follow up). In addition to the assessment of physical activity in
      daily life and balance, the investigators will also evaluate pulmonary function, peripheral
      and respiratory muscle strength, body composition, maximal and submaximal exercise capacity,
      functional status and quality of life.

      Both groups (land or water) will be submitted for 3 sessions of exercise training per week,
      with 45 minutes of duration, during 6 months. The sessions of both groups include the same
      exercises sequence. Endurance exercise training will be performed on a bicycle and walking on
      land and strength training using free weights. Workload will be established according to the
      tests performance on assessment and progression will follow a predetermined schedule and
      adjusted according symptoms. On water the same approach will be followed.

      Expected results: the investigators expect improvement in terms of symptoms, exercise
      capacity, muscle strength, quality of life, functional status and physical activity in daily
      life at the end of the two training protocols. However, it is unclear whether one training
      protocol will be superior than the other. Due to the characteristics involved in the aquatic
      training, the investigators hypothesized that this type of training can result in better
      results on balance.
There is evidence that demonstrate the beneficial effects of pulmonary rehabilitation
      programs (PR) on symptoms, exercise capacity, muscle strength and quality of life in patients
      with Chronic obstructive pulmonary disease (COPD). The majority of the studies used high
      intensity endurance and strength exercise training on land. Exercise on water is an effective
      form of training that has been used for decades for rehabilitation in different chronic
      conditions. In addition, there are promising preliminary results on the literature regarding
      aquatic training in patients with COPD. However, several gaps remain.

      Therefore, we aim to compare the effects of two rehabilitation programs with 6 months of
      duration in patients with COPD on physical activity in daily life and balance: land versus
      water.

      The sample will consist of 36 patients with COPD diagnosed according to the GOLD criteria, 50
      years old or more and clinically stable.

      Patients will be evaluated in 3 different moments: before the PR, after the PR and 6 months
      after the end of the PR (follow up). In addition to the assessment of physical activity in
      daily life and balance, the investigators will also evaluate pulmonary function, peripheral
      and respiratory muscle strength, body composition, maximal and submaximal exercise capacity,
      functional status and quality of life.

      Both groups (land or water) will be submitted for 3 sessions of exercise training per week,
      with 45 minutes of duration, during 6 months. The sessions of both groups include the same
      exercises sequence. Endurance exercise training will be performed on a bicycle and walking on
      land and strength training using free weights. Workload will be established according to the
      tests performance on assessment and progression will follow a predetermined schedule and
      adjusted according symptoms. On water the same approach will be followed.

      Expected results: the investigators expect improvement in terms of symptoms, exercise
      capacity, muscle strength, quality of life, functional status and physical activity in daily
      life at the end of the two training protocols. However, it is unclear whether one training
      protocol will be superior than the other. Due to the characteristics involved in the aquatic
      training, the investigators hypothesized that this type of training can result in better
      results on balance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Physical activity in daily life (measuremet unit: number of steps per day)
time frame: four years
description: The objectively assessed level of physical activity in daily life will be monitored using the activity monitor Power Walker PW 610 (Yamax, Japan). This device is validated in patients with COPD and the main variables are the number of steps per day and estimation of daily energy expenditure. The monitor will be individually set taking into consideration body weight and step length (measured in a 10-meter walking at usual speed). Patients will wear the device 12 hours per day during 6 days, and the average of these six days will be used for analysis.
measure: Static Balance (Center of Pressure Area in cm2)
time frame: four years
description: Static balance will be evaluated using a force platform (BIOMEC400, EMG System of Brazil, Brazil), which is a reliable instrument for stabilographic measures in both, older and young adults.
measure: Dynamic Balance (Timed up and go test in seconds)
time frame: four years
description: Dynamic balance will be assessed by Timed up and go test (TUG).
measure: Exercise capacity (6MWT: distance covered in meters; ISWT: distance covered in meters)
time frame: four years
description: The 6-minute walking test (6MWT) will be performed to verify functional exercise capacity and the Incremental shuttle walk test (ISWT) to assess maximal exercise capacity.
measure: Quality of life (CRDQ: score in points)
time frame: four years
description: The Chronic Respiratory Disease Questionnaire (CRDQ) will be applied to assess quality of life.
measure: Functional status (LCADL: score in points)
time frame: four years
description: Functional status will be assessed by using the questionnaire "London Chest Activity of Daily Living scale" (LCADL). A total score is calculated according to the patient report for each domain.
arm group label: Exercise training on land
arm group type: Other
description: High intensity exercise training on land.
arm group label: Exercise training on water
arm group type: Other
description: High intensity exercise training on water.
intervention type: Other
intervention name: Exercise training
description: Comparison of high intensity exercise training on land versus water.
arm group label: Exercise training on land
arm group label: Exercise training on water
other name: Exercise training on land;
other name: Exercise training on water.
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Fabio Pitta, PhD
role: Study Director
affiliation: Universidade Estadual de Londrina
last name: Vanessa S. Probst, PhD
role: Principal Investigator
affiliation: Universidade Norte do Paraná
facility: 
country: Brazil
responsible party type: Sponsor
sharing ipd: No