<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/NCT03782779</url>
  </required_header>
  <id_info>
    <org_study_id>ID001</org_study_id>
    <nct_id>NCT03782779</nct_id>
  </id_info>
  <brief_title>Diaphragmatic Breathing Program In Older People</brief_title>
  <acronym>BP-OP</acronym>
  <official_title>Respiratory Physical Therapy Based on Diaphragmatic Breathing Program In Institutionalized Older People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</source>
  <oversight_info>
    <has_dmc>No</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>
      In the present study a program of respiratory physical therapy based on diaphragmatic&#xD;
      breathing is applied in institutionalized old people, evaluating lung function parameters&#xD;
      (FVC, FEV1, FEV1/FVC) and oxygen saturation.&#xD;
&#xD;
      The hypothesis is that a diaphragmatic breathing program applied in elderly people can&#xD;
      improve the respiratory system's function and consequently improve their daily life. This&#xD;
      program will include learning and performing a diaphragmatic-abdominal breathing, and&#xD;
      incorporating the new breathing pattern to a upper and lower limbs maintenance exercises as&#xD;
      well as to daily life activities.&#xD;
&#xD;
      Methods: randomized and controlled clinical study of respiratory parameters of&#xD;
      institutionalized old people. The subjects will be divided into 2 groups: 1) diaphragmatic&#xD;
      breathing program and upper and lower limbs maintenance exercises 2) control group which do&#xD;
      upper and lower limbs maintenance exercises. There will be 3 treatment sessions during 8&#xD;
      weeks, with evaluations before the study and after 8 weeks, which include: lung function&#xD;
      parameters (forced vital capacity, forced expiratory volume in one second, Tiffeneau Index)&#xD;
      and pulseoximeter (which includes oxygen saturation and cardiac frequency).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction.The aging of the respiratory system includes physiological changes of the lung&#xD;
      as well as the osteoarticular and muscular tissues. Therefore, the European and North&#xD;
      American Respiratory Societies highlight in their recommendations the importance of&#xD;
      prevention of respiratory diseases. They also insist on the need to maintain the integrity of&#xD;
      the anatomical elements that participate in the thoraco-abdominal movements and on preventive&#xD;
      treatments in those at risk before the symptoms appear.&#xD;
&#xD;
      Objective. The main objective of this study is to apply a program of supervised breathing&#xD;
      program in old people with no respiratory health issues and evaluate the effects on&#xD;
      respiratory variables such as forced vital capacity (FVC) forced expiratory volume in one&#xD;
      second (FEV1) Tiffeneau Index (FEV1/FVC) and oxygen satutarion (SO2).&#xD;
&#xD;
      Material and Methods Sample: over 60 year old subjects, institutionalized and with no&#xD;
      respiratory condition.&#xD;
&#xD;
      Study design. Randomized clinical trial with 2 groups: Group 1. diaphragmatic breathing&#xD;
      program and upper and lower limbs maintenance exercises ; Group 2. control group which only&#xD;
      do upper and lower limbs maintenance exercises.&#xD;
&#xD;
      Evaluations. Clinical interview with anthropometric data and health characteristics.&#xD;
&#xD;
      There will be 2 evaluations: at the beginning of the study and at the end of the supervised&#xD;
      program (at 8 weeks).&#xD;
&#xD;
      In addition, it includes the following evaluation instruments:&#xD;
&#xD;
        -  Mini-mental State Examination (MMSE)&#xD;
&#xD;
        -  Spirometry: obtaining FVC, FEV1, FEV1/FVC.&#xD;
&#xD;
        -  Pulse oxymetry: it measure the SaO2 and cardiac frequency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">March 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 7, 2019</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Forced spirometry</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed using a COSMED PONY FX spirometer with mouthpiece and filters (1 cardboard mouthpiece and a bacteriological filter per patient). The test was performed with the person sitting, without crossing the legs and shoulders relaxed. Anthropometric data were entered into the equipment, nose was covered with a nose clio and the patient was then asked to perform three forced inhalations and exhalations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse oxymetry</measure>
    <time_frame>8 weeks</time_frame>
    <description>To assess oxygen saturation, a SmartOx pulse oximeter (WEINMANN Medical Technology) is used. The subject remains seated, the pulse oximeter clamp placed on a finger of one of the hands, waiting for the SaO2 and CF value to stabilize and register the value.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minimental State Examination Folstein</measure>
    <time_frame>first week</time_frame>
    <description>Mini-Cognitive Lobo est (MEC). To assess the cognitive status before inclusion in the study, the spanish version of Folstein's Minimental State Examination is used. Adapted and validated by Lobo in Spain in 1979. It is a brief cognitive test that consists of the evaluation of the most important cognitive areas (orientation, concentration, calculation, memory, language and construction) with a global maximum score of 35 (30-35 = normal, 24-29 = borderline, &lt;24 in people over 65). The MEC has widely shown its reliability, validity and discriminative power, with a specificity of 75.1% and a sensitivity of 89.8%.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Breathing program and regular exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diaphragmatic Breathing Program plus regular upper and lower limb exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Regular upper and lower limb exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breathing program and regular exercise</intervention_name>
    <description>This program will be supervised by a physical therapist and will include learning and performing a diaphragmatic-abdominal breathing, and incorporating the new breathing pattern to a upper and lower limbs regular exercises as well as to daily life activities.</description>
    <arm_group_label>Breathing program and regular exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regular Exercise</intervention_name>
    <description>Regular upper and lower limbs exercises supervised by a physical therapist</description>
    <arm_group_label>Regular Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  institutionalized subjects older than or equal to 60 years&#xD;
&#xD;
          -  without respiratory pathology diagnosed&#xD;
&#xD;
          -  with adequate cognitive status to follow the protocol of respiratory exercises&#xD;
             (MEC&gt;30) .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects with respiratory diseases&#xD;
&#xD;
          -  Subjects with musculoskeletal injuries that prevented the performance of the exercise&#xD;
             protocol were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Arnal-Gómez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Valencia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>May 18, 2020</last_update_submitted>
  <last_update_submitted_qc>May 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Anna Arnal</investigator_full_name>
    <investigator_title>PhD, Profesora Ayudante</investigator_title>
  </responsible_party>
  <keyword>Respiratory physical therapy</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/NCT03782779
org study id: ID001
nct id: NCT03782779
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the present study a program of respiratory physical therapy based on diaphragmatic
      breathing is applied in institutionalized old people, evaluating lung function parameters
      (FVC, FEV1, FEV1/FVC) and oxygen saturation.

      The hypothesis is that a diaphragmatic breathing program applied in elderly people can
      improve the respiratory system's function and consequently improve their daily life. This
      program will include learning and performing a diaphragmatic-abdominal breathing, and
      incorporating the new breathing pattern to a upper and lower limbs maintenance exercises as
      well as to daily life activities.

      Methods: randomized and controlled clinical study of respiratory parameters of
      institutionalized old people. The subjects will be divided into 2 groups: 1) diaphragmatic
      breathing program and upper and lower limbs maintenance exercises 2) control group which do
      upper and lower limbs maintenance exercises. There will be 3 treatment sessions during 8
      weeks, with evaluations before the study and after 8 weeks, which include: lung function
      parameters (forced vital capacity, forced expiratory volume in one second, Tiffeneau Index)
      and pulseoximeter (which includes oxygen saturation and cardiac frequency).
Introduction.The aging of the respiratory system includes physiological changes of the lung
      as well as the osteoarticular and muscular tissues. Therefore, the European and North
      American Respiratory Societies highlight in their recommendations the importance of
      prevention of respiratory diseases. They also insist on the need to maintain the integrity of
      the anatomical elements that participate in the thoraco-abdominal movements and on preventive
      treatments in those at risk before the symptoms appear.

      Objective. The main objective of this study is to apply a program of supervised breathing
      program in old people with no respiratory health issues and evaluate the effects on
      respiratory variables such as forced vital capacity (FVC) forced expiratory volume in one
      second (FEV1) Tiffeneau Index (FEV1/FVC) and oxygen satutarion (SO2).

      Material and Methods Sample: over 60 year old subjects, institutionalized and with no
      respiratory condition.

      Study design. Randomized clinical trial with 2 groups: Group 1. diaphragmatic breathing
      program and upper and lower limbs maintenance exercises ; Group 2. control group which only
      do upper and lower limbs maintenance exercises.

      Evaluations. Clinical interview with anthropometric data and health characteristics.

      There will be 2 evaluations: at the beginning of the study and at the end of the supervised
      program (at 8 weeks).

      In addition, it includes the following evaluation instruments:

        -  Mini-mental State Examination (MMSE)

        -  Spirometry: obtaining FVC, FEV1, FEV1/FVC.

        -  Pulse oxymetry: it measure the SaO2 and cardiac frequency.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Forced spirometry
time frame: 8 weeks
description: Assessed using a COSMED PONY FX spirometer with mouthpiece and filters (1 cardboard mouthpiece and a bacteriological filter per patient). The test was performed with the person sitting, without crossing the legs and shoulders relaxed. Anthropometric data were entered into the equipment, nose was covered with a nose clio and the patient was then asked to perform three forced inhalations and exhalations.
measure: Pulse oxymetry
time frame: 8 weeks
description: To assess oxygen saturation, a SmartOx pulse oximeter (WEINMANN Medical Technology) is used. The subject remains seated, the pulse oximeter clamp placed on a finger of one of the hands, waiting for the SaO2 and CF value to stabilize and register the value.
measure: Minimental State Examination Folstein
time frame: first week
description: Mini-Cognitive Lobo est (MEC). To assess the cognitive status before inclusion in the study, the spanish version of Folstein's Minimental State Examination is used. Adapted and validated by Lobo in Spain in 1979. It is a brief cognitive test that consists of the evaluation of the most important cognitive areas (orientation, concentration, calculation, memory, language and construction) with a global maximum score of 35 (30-35 = normal, 24-29 = borderline, <24 in people over 65). The MEC has widely shown its reliability, validity and discriminative power, with a specificity of 75.1% and a sensitivity of 89.8%.
arm group label: Breathing program and regular exercise
arm group type: Experimental
description: Diaphragmatic Breathing Program plus regular upper and lower limb exercises
arm group label: Regular Exercise
arm group type: Active Comparator
description: Regular upper and lower limb exercises
intervention type: Other
intervention name: Breathing program and regular exercise
description: This program will be supervised by a physical therapist and will include learning and performing a diaphragmatic-abdominal breathing, and incorporating the new breathing pattern to a upper and lower limbs regular exercises as well as to daily life activities.
arm group label: Breathing program and regular exercise
intervention type: Other
intervention name: Regular Exercise
description: Regular upper and lower limbs exercises supervised by a physical therapist
arm group label: Regular Exercise
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anna Arnal-Gómez, PhD
role: Principal Investigator
affiliation: University of Valencia
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Anna Arnal
investigator title: PhD, Profesora Ayudante