xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05972239</url>
    </required_header>
    <id_info>
      <org_study_id>2763</org_study_id>
      <nct_id>NCT05972239</nct_id>
    </id_info>
    <brief_title>Balance Training in Chronic Obstructive Pulmonary Disease</brief_title>
    <official_title>Balance Training: Its Effect on Pulmonary Rehabilitation of Elderly Subjects With Chronic Obstructive Pulmonary Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istituti Clinici Scientifici Maugeri SpA</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istituti Clinici Scientifici Maugeri SpA</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study will be to verify whether the addition of an exercise program aimed to&#xD;
        improve balance can reduce the risk of falling in subjects with COPD over 80 years of age&#xD;
        compared to the standard rehabilitation program. Patients will be randomly assigned in two&#xD;
        groups (intervention and control). The pulmonary rehabilitation (PR) program is organized in&#xD;
        accordance with current guidelines.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic Obstructive Pulmonary Disease-COPD is the most prevalent pathology among chronic&#xD;
        airway diseases. The average age of life has increased. Subjects over 80 years old have&#xD;
        peculiar characteristics. Individuals with COPD have an increased risk of falling compared&#xD;
        with healthy peers. A pulmonary rehabilitation program reduces the risk of falling as&#xD;
        measured by gait speed. Balance training on the elderly has been shown to be effective in&#xD;
        improving muscle strength, coordination, balance and in reducing the risk and number of falls&#xD;
        and the fear of falling.&#xD;
  &#xD;
        The enrolled subjects will complete an in-patient PR program according to enrollment.&#xD;
  &#xD;
        Control: education, aerobic and strength training and callisthenic exercises. Intervention:&#xD;
        education, aerobic and strength training as group Control and balance training. At baseline&#xD;
        will be recorded: demographics and anthropometrics, comorbidities, drug therapy, flow/volume&#xD;
        curve, arterial blood gases, serum hemoglobin, history of fall, exacerbations and risk of&#xD;
        sarcopenia. Before and after the PR the following outcome measures will be assessed: balance&#xD;
        performance, peripheral muscle strength, gait speed, health status, dyspnea, quality of life,&#xD;
        exercise capacity, confidence with balance and perceived change. Sample size calculation was&#xD;
        performed based on the primary endpoint of the study. We estimate a number of 50 subjects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Balance</measure>
      <time_frame>3 weeks</time_frame>
      <description>Berg Balance Scale (BBS). Scores range from 0 (worst) - 4 (best).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Peripheral muscle strenght</measure>
      <time_frame>3 weeks</time_frame>
      <description>Five sit to stand test (5STS). Time &lt; 14.9 seconds (best), &gt;14.8 seconds (worst).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gait speed</measure>
      <time_frame>3 weeks</time_frame>
      <description>4-meter gait speed test (4MGS). Time &lt; 4.83 seconds (best), &gt;4.82 seconds (worst).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health status</measure>
      <time_frame>3 weeks</time_frame>
      <description>The COPD Assessment Test (CAT) score ranges from 0 (best) to 40 (worst).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dyspnea</measure>
      <time_frame>3 weeks</time_frame>
      <description>Medical Research Council (mMRC) score ranges from 0 (best) to 4 (worst).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dyspnea on daily life activities</measure>
      <time_frame>3 weeks</time_frame>
      <description>Barthel Dyspnea Index (BDI) total score ranges from 0 (best) to 100 (worst).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>COPD Quality of life</measure>
      <time_frame>3 weeks</time_frame>
      <description>EuroQoL-5D total score ranges from 0 (worst) to 100 (best).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exercise capacity</measure>
      <time_frame>3 weeks</time_frame>
      <description>Six-Minute Walking Test (6MWT) measures the maximum walked distance in meters (m) in a given time (6 minutes).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Confidence with balance</measure>
      <time_frame>3 weeks</time_frame>
      <description>Activities-specific Balance Confidence short form (ABC-6) Scale. Score from 0 (worst) to 100 (best).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived change</measure>
      <time_frame>3 weeks</time_frame>
      <description>Global perceived effect (GPE) scale. Score range from 1 (best) to 7 (worst).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>COPD</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Educational interventions, aerobic and strenght training, flexibility exercises.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Educational interventions, aerobic and strenght training, balance training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard pulmonary rehabilitation program</intervention_name>
      <description>Educational interventions, 3 individual sessions of 10-20 minutes and 1 weekly group meeting of 45-60 minutes on nutrition and on the emotional management of the disease. Supervised and incremental aerobic training, lasting at least 30 minutes, 5/6 days a week for a total of 12-14 sessions. The initial workload will be set between 50-70% of the maximum load (watts) determined starting from the 6MWT using the Hill equation and will be increased to reach a perception of moderate-intense fatigue and/or dyspnea. Supervised strength training of the lower limbs and upper limbs, lasting 30 minutes, 5/6 times a week for a total of 12-14 sessions. The workload will be calibrated to allow the execution of 12 consecutive repetitions and will be progressively increased by 0.5 kg in order to cause a moderate/intense fatigue and/or dyspnea. Group exercises aimed at improving flexibility of the trunk, lower and upper limbs, lasting at least 30 minutes, 5/6 days a week, for a total of 12-14 sessions.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Balance training added on standard pulmonary rehabilitation</intervention_name>
      <description>Educational interventions, 3 individual sessions of 10-20 minutes and 1 weekly group meeting of 45-60 minutes on nutrition and on the emotional management of the disease. Supervised and incremental aerobic training, lasting at least 30 minutes, 5/6 days a week for a total of 12-14 sessions. The initial workload will be set between 50-70% of the maximum load determined from the 6MWT (Hill equation) and will be increased based on dyspnea. Supervised strength training of the lower limbs and upper limbs, lasting 30 minutes, 5/6 times a week for a total of 12-14 sessions. The workload will be progressively increased. Supervised balance training sessions lasting 30 minutes, 5/6 times a week for a total of 12-14 sessions. The sequence of the exercises will be personalized according to the result of the Berg Balance Scale and modified according to the progress.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 80 years old,&#xD;
  &#xD;
            -  Diagnosis of COPD according to GOLD Guidelines (Tiffenau Index &lt;70%) under optimized&#xD;
               medical treatment,&#xD;
  &#xD;
            -  Able to perform and complete study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Anticholinergic Cognitive Burden score ≥3,&#xD;
  &#xD;
            -  Mini-Mental State Examination &lt;22,&#xD;
  &#xD;
            -  Acute or chronic impairment and/or medical diseases that are likely to preclude&#xD;
               exercise testing and PR.&#xD;
  &#xD;
            -  Brain lesions,&#xD;
  &#xD;
            -  Inner ear disease&#xD;
  &#xD;
            -  Visual deficit,&#xD;
  &#xD;
            -  Lower limb surgery in the previous 6 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>80 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Elisabetta Zampogna, dr</last_name>
      <phone>3335442246</phone>
      <email>elisabetta.zampogna@icsmaugeri.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Antonio Spanevello, Prof</last_name>
      <email>antonio.spanevello@icsmaugeri.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of pulmonary rehabilitation</name>
        <address>
          <city>Tradate</city>
          <state>Varese</state>
          <zip>21049</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elisabetta Zampogna, Dr</last_name>
        <phone>+393335442246</phone>
        <email>elisabetta.zampogna@icsmaugeri.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istituti Clinici Scientifici Maugeri SpA</investigator_affiliation>
      <investigator_full_name>Elisabetta Zampogna</investigator_full_name>
      <investigator_title>Dr</investigator_title>
    </responsible_party>
    <keyword>Exercise</keyword>
    <keyword>Rehabilitation</keyword>
    <keyword>Aged</keyword>
    <keyword>postural balance</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05972239
  org study id: 2763
  nct id: NCT05972239
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study will be to verify whether the addition of an exercise program aimed to
        improve balance can reduce the risk of falling in subjects with COPD over 80 years of age
        compared to the standard rehabilitation program. Patients will be randomly assigned in two
        groups (intervention and control). The pulmonary rehabilitation (PR) program is organized in
        accordance with current guidelines.
  Chronic Obstructive Pulmonary Disease-COPD is the most prevalent pathology among chronic
        airway diseases. The average age of life has increased. Subjects over 80 years old have
        peculiar characteristics. Individuals with COPD have an increased risk of falling compared
        with healthy peers. A pulmonary rehabilitation program reduces the risk of falling as
        measured by gait speed. Balance training on the elderly has been shown to be effective in
        improving muscle strength, coordination, balance and in reducing the risk and number of falls
        and the fear of falling.
  
        The enrolled subjects will complete an in-patient PR program according to enrollment.
  
        Control: education, aerobic and strength training and callisthenic exercises. Intervention:
        education, aerobic and strength training as group Control and balance training. At baseline
        will be recorded: demographics and anthropometrics, comorbidities, drug therapy, flow/volume
        curve, arterial blood gases, serum hemoglobin, history of fall, exacerbations and risk of
        sarcopenia. Before and after the PR the following outcome measures will be assessed: balance
        performance, peripheral muscle strength, gait speed, health status, dyspnea, quality of life,
        exercise capacity, confidence with balance and perceived change. Sample size calculation was
        performed based on the primary endpoint of the study. We estimate a number of 50 subjects.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Balance
  time frame: 3 weeks
  description: Berg Balance Scale (BBS). Scores range from 0 (worst) - 4 (best).
  measure: Peripheral muscle strenght
  time frame: 3 weeks
  description: Five sit to stand test (5STS). Time < 14.9 seconds (best), >14.8 seconds (worst).
  measure: Gait speed
  time frame: 3 weeks
  description: 4-meter gait speed test (4MGS). Time < 4.83 seconds (best), >4.82 seconds (worst).
  measure: Health status
  time frame: 3 weeks
  description: The COPD Assessment Test (CAT) score ranges from 0 (best) to 40 (worst).
  measure: Dyspnea
  time frame: 3 weeks
  description: Medical Research Council (mMRC) score ranges from 0 (best) to 4 (worst).
  measure: Dyspnea on daily life activities
  time frame: 3 weeks
  description: Barthel Dyspnea Index (BDI) total score ranges from 0 (best) to 100 (worst).
  measure: COPD Quality of life
  time frame: 3 weeks
  description: EuroQoL-5D total score ranges from 0 (worst) to 100 (best).
  measure: Exercise capacity
  time frame: 3 weeks
  description: Six-Minute Walking Test (6MWT) measures the maximum walked distance in meters (m) in a given time (6 minutes).
  measure: Confidence with balance
  time frame: 3 weeks
  description: Activities-specific Balance Confidence short form (ABC-6) Scale. Score from 0 (worst) to 100 (best).
  measure: Perceived change
  time frame: 3 weeks
  description: Global perceived effect (GPE) scale. Score range from 1 (best) to 7 (worst).
  arm group label: Control
  arm group type: Active Comparator
  description: Educational interventions, aerobic and strenght training, flexibility exercises.
  arm group label: Intervention
  arm group type: Experimental
  description: Educational interventions, aerobic and strenght training, balance training.
  intervention type: Other
  intervention name: Standard pulmonary rehabilitation program
  description: Educational interventions, 3 individual sessions of 10-20 minutes and 1 weekly group meeting of 45-60 minutes on nutrition and on the emotional management of the disease. Supervised and incremental aerobic training, lasting at least 30 minutes, 5/6 days a week for a total of 12-14 sessions. The initial workload will be set between 50-70% of the maximum load (watts) determined starting from the 6MWT using the Hill equation and will be increased to reach a perception of moderate-intense fatigue and/or dyspnea. Supervised strength training of the lower limbs and upper limbs, lasting 30 minutes, 5/6 times a week for a total of 12-14 sessions. The workload will be calibrated to allow the execution of 12 consecutive repetitions and will be progressively increased by 0.5 kg in order to cause a moderate/intense fatigue and/or dyspnea. Group exercises aimed at improving flexibility of the trunk, lower and upper limbs, lasting at least 30 minutes, 5/6 days a week, for a total of 12-14 sessions.
  arm group label: Control
  intervention type: Other
  intervention name: Balance training added on standard pulmonary rehabilitation
  description: Educational interventions, 3 individual sessions of 10-20 minutes and 1 weekly group meeting of 45-60 minutes on nutrition and on the emotional management of the disease. Supervised and incremental aerobic training, lasting at least 30 minutes, 5/6 days a week for a total of 12-14 sessions. The initial workload will be set between 50-70% of the maximum load determined from the 6MWT (Hill equation) and will be increased based on dyspnea. Supervised strength training of the lower limbs and upper limbs, lasting 30 minutes, 5/6 times a week for a total of 12-14 sessions. The workload will be progressively increased. Supervised balance training sessions lasting 30 minutes, 5/6 times a week for a total of 12-14 sessions. The sequence of the exercises will be personalized according to the result of the Berg Balance Scale and modified according to the progress.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 80 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Elisabetta Zampogna, dr
  phone: 3335442246
  email: elisabetta.zampogna@icsmaugeri.it
  last name: Antonio Spanevello, Prof
  email: antonio.spanevello@icsmaugeri.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Istituti Clinici Scientifici Maugeri SpA
  investigator full name: Elisabetta Zampogna
  investigator title: Dr
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  sharing ipd: Undecided