<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/NCT03273959</url>
  </required_header>
  <id_info>
    <org_study_id>16-0126</org_study_id>
    <nct_id>NCT03273959</nct_id>
  </id_info>
  <brief_title>Program Of Exercises During The Hospitalization Of Children And Adolescents With Cystic Fibrosis</brief_title>
  <official_title>Effects Of An Exercise Program During The Hospitalization Of Children And Adolescents With Cystic Fibrosis: Randomized Clinical Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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 objective of this study was to evaluate the effect of a physical exercise program on the&#xD;
      functional capacity of children and adolescents with cystic fibrosis hospitalized at the&#xD;
      Hospital de Clínicas of Porto Alegre (HCPA) through a six-minute walk test using the distance&#xD;
      traveled In six minutes.&#xD;
&#xD;
      In the first 48 hours of hospital stay, the following evaluations will be performed:&#xD;
      Six-minute walk test, physical and health fitness test, spirometry and data collection.&#xD;
      Patients will be randomized to either control group or intervention group. The control group&#xD;
      will receive the conventional treatment offered by hospital care, the intervention group will&#xD;
      receive this same treatment plus an exercise protocol. After 14 days they will be reevaluated&#xD;
      with the same tests applied at the beginning of hospitalization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the study is to evaluate the effect of a protocol of physical exercises on&#xD;
      the functional capacity of children and adolescents with cystic fibrosis, hospitalized, in&#xD;
      the stage of exacerbation of the disease.&#xD;
&#xD;
      In the first 48 hours of hospitalization patients and their caregivers will be invited to&#xD;
      participate in the study. We will start with the following evaluations: Six-minute walk test,&#xD;
      spirometry, physical fitness and health test (includes: walking, abdominal, flexibility and&#xD;
      abdominal circumference), clinical score of shwachman kulczycki and Collected data from&#xD;
      medical records.&#xD;
&#xD;
      After the initial evaluation the patient will be randomized to control group or intervention&#xD;
      group. The control group will receive the conventional physiotherapy by the assistance team&#xD;
      and the recreation service by the physical education. The intervention group will receive the&#xD;
      same assistance plus the intervention with the exercise protocol five times a week supervised&#xD;
      by a health professional. The exercise protocol includes: Punching, climbing and descending&#xD;
      steps, sit and stand, push-ups on the wall, stationary gait, abdominal, physiotherapy bridge,&#xD;
      jumping on the floor ladder, cycling on the cycle ergometer and stretching.&#xD;
&#xD;
      At hospital discharge both groups will repeat the initial tests. The hypothesis is that the&#xD;
      intervention group showed an improvement in functional capacity compared to the control&#xD;
      group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Anticipated">March 28, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 28, 2018</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>
    <intervention_model_description>Patients will be randomized into two groups: control and intervention.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The evaluator who will apply the tests at the beginning and end of the hospital stay will be blinded. The evaluator who will apply the tests at the beginning and end of the hospital stay will be blinded. Another health professional who will participate in the research will apply the protocol of supervised exercises in patients who are randomized to the intervention group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Functional capacity</measure>
    <time_frame>14 days</time_frame>
    <description>Evaluate the distance covered by the six-minute walk test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulmonary functional capacity</measure>
    <time_frame>14 days</time_frame>
    <description>Spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical fitness and health</measure>
    <time_frame>14 days</time_frame>
    <description>Generate a score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical score Shwachman-Kulczycki</measure>
    <time_frame>14 days</time_frame>
    <description>Scoring for general activity, physical examination, nutrition and radiological findings of the thorax.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bacteriology</measure>
    <time_frame>14 days</time_frame>
    <description>The last bacteriological exams will be noted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutrition assessment</measure>
    <time_frame>14 days</time_frame>
    <description>Body mass index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cystic Fibrosis</condition>
  <condition>Cystic Fibrosis in Children</condition>
  <condition>Cystic Fibrosis Pulmonary Exacerbation</condition>
  <condition>Cystic Fibrosis With Exacerbation</condition>
  <arm_group>
    <arm_group_label>Group control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomized to the control group will receive routine physiotherapeutic follow-up, performed by the physiotherapist of the hospital during the hospitalization period. Supervision includes inhalation therapy and respiratory physiotherapy. Respiratory exercises and thoracic maneuvers for bronchial hygiene will be performed, according to what the patient is accustomed to perform. Other techniques besides these can be added at the discretion of the physiotherapist according to the needs of the patient. In pediatric hospitalization patients also receive care from physical educators who associate recreational and recreational activities with the treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the intervention group, in addition to routine physical therapy follow-up, will receive a program of physical exercises, illustrated in the form of a booklet and guided by a health professional. The patient is instructed to perform physical exercises five times a week until a hospital discharge. The participant will receive with a booklet a diary to write down the days in which to carry out the proposed exercises, in case of fault he will write down the reason for not performing. The exercise protocol includes: Punching, climbing and descending steps, sit and stand, push-ups on the wall, stationary gait, abdominal, physiotherapy bridge, jumping on the floor ladder, cycling on the cycle ergometer and stretching.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise protocol</intervention_name>
    <description>Protocol of exercises performed in hospital admission in children and adolescents with cystic fibrosis in the exacerbation phase.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  They will be included in the study of patients from 6 to 18 years old, regularly&#xD;
             followed by the Pediatric Pulmonology team of the HCPA, with diagnosis of cystic&#xD;
             fibrosis according to the consensus criteria admitted to hospital admission due to&#xD;
             exacerbation of the disease.&#xD;
&#xD;
          -  Hospital admission is defined as a stay of 24 hours or more in any HCPA unit.&#xD;
&#xD;
          -  An exacerbation of lung disease is defined as the presence of one or more of the&#xD;
             following: Change in sputum volume and color, new or enlarged hemoptysis, increased&#xD;
             cough, increased dyspnoea, malaise, fatigue, lethargy, fever, anorexia or Loss of&#xD;
             weight, headache or pain in the sinuses, alteration of the pulmonary auscultation,&#xD;
             non-FEV1 decrease of more than 10%, radiological, eradication of new bacteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cardiac, orthopedic or trauma complications that make it impossible to&#xD;
             perform the proposed exercises;&#xD;
&#xD;
          -  Patients with hemodynamic instability, massive hemoptysis, pneumothorax, and&#xD;
             continuous use of noninvasive ventilation.&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruna Ziegler</last_name>
    <role>Study Director</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bruna Ziegler</last_name>
    <phone>5551991221192</phone>
    <email>brunaziegler@yahoo.com.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Taiane Feiten</last_name>
    <phone>5551991539788</phone>
    <email>taifeiten@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bruna Ziegler</last_name>
      <phone>5551991221192</phone>
      <email>brunaziegler@yahoo.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Taiane Feiten</last_name>
      <phone>5551991539788</phone>
      <email>taifeiten@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physiotherapy</keyword>
  <keyword>Physical Therapy</keyword>
  <keyword>Exercise</keyword>
  <keyword>Hospitalization</keyword>
  <keyword>Pediatric</keyword>
  <keyword>Adolescents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03273959
org study id: 16-0126
nct id: NCT03273959
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study was to evaluate the effect of a physical exercise program on the
      functional capacity of children and adolescents with cystic fibrosis hospitalized at the
      Hospital de Clínicas of Porto Alegre (HCPA) through a six-minute walk test using the distance
      traveled In six minutes.

      In the first 48 hours of hospital stay, the following evaluations will be performed:
      Six-minute walk test, physical and health fitness test, spirometry and data collection.
      Patients will be randomized to either control group or intervention group. The control group
      will receive the conventional treatment offered by hospital care, the intervention group will
      receive this same treatment plus an exercise protocol. After 14 days they will be reevaluated
      with the same tests applied at the beginning of hospitalization.
The objective of the study is to evaluate the effect of a protocol of physical exercises on
      the functional capacity of children and adolescents with cystic fibrosis, hospitalized, in
      the stage of exacerbation of the disease.

      In the first 48 hours of hospitalization patients and their caregivers will be invited to
      participate in the study. We will start with the following evaluations: Six-minute walk test,
      spirometry, physical fitness and health test (includes: walking, abdominal, flexibility and
      abdominal circumference), clinical score of shwachman kulczycki and Collected data from
      medical records.

      After the initial evaluation the patient will be randomized to control group or intervention
      group. The control group will receive the conventional physiotherapy by the assistance team
      and the recreation service by the physical education. The intervention group will receive the
      same assistance plus the intervention with the exercise protocol five times a week supervised
      by a health professional. The exercise protocol includes: Punching, climbing and descending
      steps, sit and stand, push-ups on the wall, stationary gait, abdominal, physiotherapy bridge,
      jumping on the floor ladder, cycling on the cycle ergometer and stretching.

      At hospital discharge both groups will repeat the initial tests. The hypothesis is that the
      intervention group showed an improvement in functional capacity compared to the control
      group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized into two groups: control and intervention.
primary purpose: Treatment
masking: Single (Investigator)
masking description: The evaluator who will apply the tests at the beginning and end of the hospital stay will be blinded. The evaluator who will apply the tests at the beginning and end of the hospital stay will be blinded. Another health professional who will participate in the research will apply the protocol of supervised exercises in patients who are randomized to the intervention group.
measure: Functional capacity
time frame: 14 days
description: Evaluate the distance covered by the six-minute walk test
measure: Pulmonary functional capacity
time frame: 14 days
description: Spirometry
measure: Physical fitness and health
time frame: 14 days
description: Generate a score.
measure: Clinical score Shwachman-Kulczycki
time frame: 14 days
description: Scoring for general activity, physical examination, nutrition and radiological findings of the thorax.
measure: bacteriology
time frame: 14 days
description: The last bacteriological exams will be noted
measure: Nutrition assessment
time frame: 14 days
description: Body mass index
arm group label: Group control
arm group type: No Intervention
description: Patients randomized to the control group will receive routine physiotherapeutic follow-up, performed by the physiotherapist of the hospital during the hospitalization period. Supervision includes inhalation therapy and respiratory physiotherapy. Respiratory exercises and thoracic maneuvers for bronchial hygiene will be performed, according to what the patient is accustomed to perform. Other techniques besides these can be added at the discretion of the physiotherapist according to the needs of the patient. In pediatric hospitalization patients also receive care from physical educators who associate recreational and recreational activities with the treatment.
arm group label: Intervention group
arm group type: Experimental
description: Patients randomized to the intervention group, in addition to routine physical therapy follow-up, will receive a program of physical exercises, illustrated in the form of a booklet and guided by a health professional. The patient is instructed to perform physical exercises five times a week until a hospital discharge. The participant will receive with a booklet a diary to write down the days in which to carry out the proposed exercises, in case of fault he will write down the reason for not performing. The exercise protocol includes: Punching, climbing and descending steps, sit and stand, push-ups on the wall, stationary gait, abdominal, physiotherapy bridge, jumping on the floor ladder, cycling on the cycle ergometer and stretching.
intervention type: Other
intervention name: Exercise protocol
description: Protocol of exercises performed in hospital admission in children and adolescents with cystic fibrosis in the exacerbation phase.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Bruna Ziegler
role: Study Director
affiliation: Hospital de Clínicas de Porto Alegre
last name: Bruna Ziegler
phone: 5551991221192
email: brunaziegler@yahoo.com.br
last name: Taiane Feiten
phone: 5551991539788
email: taifeiten@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Pulmonary Fibrosis
mesh term: Fibrosis