<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/NCT03307928</url>
  </required_header>
  <id_info>
    <org_study_id>48423815.1.0000.5188</org_study_id>
    <nct_id>NCT03307928</nct_id>
  </id_info>
  <brief_title>Cardiorespiratory Responses to Exercise in Elderly</brief_title>
  <official_title>Can Obstructive Sleep Apnea Impair Cardiorespiratory Responses to Aerobic Exercise in Hypertensive Elderly?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Paraíba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Paraíba</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>
      Elderly have a high prevalence to systemic arterial hypertension (SAH) and obstructive sleep&#xD;
      apnea (OSA). Both comorbidities are closely associated and inflict injury cardiorespiratory&#xD;
      capacity. To assess cardiorespiratory responses to the cardiopulmonary exercise test (CPET)&#xD;
      among hypertensive elderly with OSA. We enrolled 25 elderly hypertensive in two different&#xD;
      groups: without OSA (No-OSA: Apnea/Hypopnea Index (AHI) &lt; 5 events/h; n = 15) and with OSA&#xD;
      (OSA: AHI ≥ 15 events/h; n = 13). All subjects underwent a CPET and polysomnographic&#xD;
      assessments. After normality and homogeneity evaluations, independent t test and pearson's&#xD;
      correlation were performed. The significance level was p ≤ 0.05.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The sample was randomly recruited from the Lauro Wanderley University Hospital and older&#xD;
      people living together centers located in João Pessoa/PB (Brazil). All subjects were&#xD;
      submitted to anthropometric assessments (body mass index, neck circumference, hip&#xD;
      circumference and waist circumference), polysomnography, echocardiography, cardiopulmonary&#xD;
      exercise test (CPET). Moreover, they were submitted to a sleep quality questionnaire&#xD;
      (Pittsburgh Sleep Quality Index).&#xD;
&#xD;
      Cardiopulmonary Exercise Test Protocol All subjects performed an incremental cardiopulmonary&#xD;
      exercise test (CPET) of maximum exercise tolerance. All procedures were performed in&#xD;
      agreement with the guidelines of the American Thoracic Society/American College of Chest&#xD;
      Physicians for cycle ergometer tests. The CPET was performed on an Inbrasport CG-04 cycle&#xD;
      ergometer (Inbrasport, Porto Alegre, Rio Grande do Sul, Brazil) with electromagnetic braking.&#xD;
      Subjects performed a 5-min warm-up with no resistance (0 W), then the activity rate was&#xD;
      increased using a ramp protocol (5-10 W.min-1) until maximum exercise tolerance. Verbal&#xD;
      encouragements were given during the CPET to ensure maximal effort.&#xD;
&#xD;
      Pulmonary gas exchange variables (VO2, VCO2, minute ventilation [VE], oxygen pulse (O2Pu),&#xD;
      respiratory quotient (R), ventilatory efficiency index (VE/VCO2slope), cardiovascular&#xD;
      function index (ΔHR/ΔVO2), deviation from oxygen consumption efficiency (OUES), metabolic&#xD;
      efficiency index (VO2/ΔWR), blood pressure (BP), heart rate (HR) recovery at first (HRR1) and&#xD;
      second (HRR2) minutes were measured breath-by-breath with an on-line gas expiration analysis&#xD;
      system (VO2000, MedGraphics, St. Paul, Minnesota, USA). Peak values were established by the&#xD;
      highest values achieved during effort.&#xD;
&#xD;
      Polysomnography Assessment All hypertensive subjects were submitted to a polysomnography exam&#xD;
      to diagnose OSA. OSA diagnosis was confirmed by the apnea/hypopnea index (AHI) and classified&#xD;
      as follows: AHI &lt; 5 events/h, absence of OSA; 5 ≤ AHI ≤ 15 events/h, low OSA; 15 ≤ AHI ≤ 30&#xD;
      events/h, moderate OSA; AHI &gt; 30 events/h, severe OSA.&#xD;
&#xD;
      The assessment was carried out during an entire night of sleep in the participant's residence&#xD;
      without the use of sedatives. The variables were monitored by an Embletta portable&#xD;
      respiratory monitor (Embla, Embletta® Gold, EUA), previously validated and in agreement with&#xD;
      manufacturer's instructions. The Embletta monitor is capable to continuously monitor pulse&#xD;
      oximetry, to detect respiratory efforts, to measure the airflow, and to record snoring&#xD;
      episodes. Additionally, HR was continually measured by the analysis of pulse waves by&#xD;
      oximetry. Finally, brain and muscle activities were monitored by electrodes, and oxygen&#xD;
      desaturation (O2D) was defined as the amount of reduction in O2S at 4%/h.&#xD;
&#xD;
      Echocardiography All subjects performed the two-dimensional color Doppler echocardiogram&#xD;
      (iE33® - Philips Electronics, Netherlands) before the CPET. Final systolic and diastolic&#xD;
      diameters of the left ventricle and the diastolic thickness of the posterior wall of the left&#xD;
      ventricle were measured from the short-axis view, and ejection fraction was obtained from&#xD;
      these measures. This exam was conducted by an experienced cardiologist, who was blinded to&#xD;
      group allocation.&#xD;
&#xD;
      Sleep Quality The subjective sleep quality was assessed by the Pittsburgh Sleep Quality&#xD;
      Index, which consists of 19 questions grouped into 7 different components (subjective sleep&#xD;
      quality, sleep latency, sleep duration, sleep efficiency, sleep disorders, use of&#xD;
      medications, and diurnal dysfunction). The classifications depended upon the scores reached&#xD;
      in each question (from 0 to 3); ranging from 0 - 4: good subjective sleep quality; 5 - 10:&#xD;
      bad subjective sleep quality; and 11 or higher: indicates the presence of at least one sleep&#xD;
      disorder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2015</start_date>
  <completion_date type="Actual">June 15, 2016</completion_date>
  <primary_completion_date type="Actual">March 31, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The participants were divided into two groups: (1) hypertension without OSA (NO-OSA group; AHI &lt; 5 events/h; n = 15) and (2) hypertension with OSA (OSA group: AHI ≥ 15 events/h; n = 13).</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The investigator did not have access to the exams that the volunteers realized, either they have access to what they were doing or the order of the exams.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea-Hypopnea Index</measure>
    <time_frame>A entire night sleep, an average of 8 yours.</time_frame>
    <description>The OSA diagnose was confirmed by the apnea/hypopnea index (AHI) and classified as follows: AHI &lt; 5 events/h, absence of OSA; 5 ≤ AHI ≤ 15 events/h, low OSA; 15 ≤ AHI ≤ 30 events/h, moderate OSA; AHI &gt; 30 events/h, severe OSA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen Consumption</measure>
    <time_frame>A entire procedure (approximately 10 minutes)</time_frame>
    <description>Following a 5-min warm-up against no resistance (0 W), the work rate was increased using a ramp protocol (5-10 W.min-1) until maximum exercise tolerance. Verbal encouragements were given during the CPET to ensure maximal effort.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Cardiopulmonary Exercise Test Protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects performed an incremental cardiopulmonary exercise test (CPET) to maximum exercise tolerance. All the procedures were performed in agreement with the American Thoracic Society/American College of Chest Physicians guidelines for cycle ergometer tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Polysomnography Assessment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All hypertensive subjects were submitted to a polysomnography exam to diagnose OSA. The OSA diagnose was confirmed by the apnea/hypopnea index (AHI) and classified as follows: AHI &lt; 5 events/h, absence of OSA; 5 ≤ AHI ≤ 15 events/h, low OSA; 15 ≤ AHI ≤ 30 events/h, moderate OSA; AHI &gt; 30 events/h, severe OSA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cardiopulmonary Exercise Test Protocol</intervention_name>
    <description>The CPET was performed in a cycle ergometer with electromagnetic braking using an Inbrasport (Inbrasport, Porto Alegre, Rio Grande do Sul, Brazil). Following a 5-min warm-up against no resistance (0 W), the work rate was increased using a ramp protocol (5-10 W.min-1) until maximum exercise tolerance. Verbal encouragements were given during the CPET to ensure maximal effort.</description>
    <arm_group_label>Cardiopulmonary Exercise Test Protocol</arm_group_label>
    <arm_group_label>Polysomnography Assessment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Polysomnography Assessment</intervention_name>
    <description>The polysomnography assessment was carried out during an entire night of sleep in the participant's residence with no use of sedatives. The variables were monitored by an Embletta portable respiratory monitor (Embla, Embletta® Gold, EUA), previously validated, and in agreement with manufacturer's instructions. The Embletta monitor was capable to monitor continuously the pulse oximetry, to detect respiratory efforts, to measure the airflow, and to record snoring episodes. Additionally, HR was continually measured by the analysis of pulse waves by oximetry. Finally, brain and muscle activities were monitored by electrodes and oxygen desaturation (O2D) was defined as the amount of reduction in O2S in 4%/h.</description>
    <arm_group_label>Cardiopulmonary Exercise Test Protocol</arm_group_label>
    <arm_group_label>Polysomnography Assessment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals in stage I or II of systemic hypertension without use of beta-blockers,&#xD;
             eutrophics, non-smokers (&lt; 6 months), with no diabetes, or any respiratory or&#xD;
             cardiovascular disease and considered irregularly active [15] were enrolled in this&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with diabetes or any respiratory or cardiovascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruno Barbosa, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro Universitário de João Pessoa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bruno Teixeira Barbosa</name>
      <address>
        <city>Joao Pessoa</city>
        <state>Paraíba</state>
        <zip>58051420</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>March 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Paraíba</investigator_affiliation>
    <investigator_full_name>Bruno Teixeira Barbosa</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Obstructive Sleep Apnea Syndrome</keyword>
  <keyword>Aged</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Oxygen Consumption</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <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/NCT03307928
org study id: 48423815.1.0000.5188
nct id: NCT03307928
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Elderly have a high prevalence to systemic arterial hypertension (SAH) and obstructive sleep
      apnea (OSA). Both comorbidities are closely associated and inflict injury cardiorespiratory
      capacity. To assess cardiorespiratory responses to the cardiopulmonary exercise test (CPET)
      among hypertensive elderly with OSA. We enrolled 25 elderly hypertensive in two different
      groups: without OSA (No-OSA: Apnea/Hypopnea Index (AHI) < 5 events/h; n = 15) and with OSA
      (OSA: AHI ≥ 15 events/h; n = 13). All subjects underwent a CPET and polysomnographic
      assessments. After normality and homogeneity evaluations, independent t test and pearson's
      correlation were performed. The significance level was p ≤ 0.05.
The sample was randomly recruited from the Lauro Wanderley University Hospital and older
      people living together centers located in João Pessoa/PB (Brazil). All subjects were
      submitted to anthropometric assessments (body mass index, neck circumference, hip
      circumference and waist circumference), polysomnography, echocardiography, cardiopulmonary
      exercise test (CPET). Moreover, they were submitted to a sleep quality questionnaire
      (Pittsburgh Sleep Quality Index).

      Cardiopulmonary Exercise Test Protocol All subjects performed an incremental cardiopulmonary
      exercise test (CPET) of maximum exercise tolerance. All procedures were performed in
      agreement with the guidelines of the American Thoracic Society/American College of Chest
      Physicians for cycle ergometer tests. The CPET was performed on an Inbrasport CG-04 cycle
      ergometer (Inbrasport, Porto Alegre, Rio Grande do Sul, Brazil) with electromagnetic braking.
      Subjects performed a 5-min warm-up with no resistance (0 W), then the activity rate was
      increased using a ramp protocol (5-10 W.min-1) until maximum exercise tolerance. Verbal
      encouragements were given during the CPET to ensure maximal effort.

      Pulmonary gas exchange variables (VO2, VCO2, minute ventilation [VE], oxygen pulse (O2Pu),
      respiratory quotient (R), ventilatory efficiency index (VE/VCO2slope), cardiovascular
      function index (ΔHR/ΔVO2), deviation from oxygen consumption efficiency (OUES), metabolic
      efficiency index (VO2/ΔWR), blood pressure (BP), heart rate (HR) recovery at first (HRR1) and
      second (HRR2) minutes were measured breath-by-breath with an on-line gas expiration analysis
      system (VO2000, MedGraphics, St. Paul, Minnesota, USA). Peak values were established by the
      highest values achieved during effort.

      Polysomnography Assessment All hypertensive subjects were submitted to a polysomnography exam
      to diagnose OSA. OSA diagnosis was confirmed by the apnea/hypopnea index (AHI) and classified
      as follows: AHI < 5 events/h, absence of OSA; 5 ≤ AHI ≤ 15 events/h, low OSA; 15 ≤ AHI ≤ 30
      events/h, moderate OSA; AHI > 30 events/h, severe OSA.

      The assessment was carried out during an entire night of sleep in the participant's residence
      without the use of sedatives. The variables were monitored by an Embletta portable
      respiratory monitor (Embla, Embletta® Gold, EUA), previously validated and in agreement with
      manufacturer's instructions. The Embletta monitor is capable to continuously monitor pulse
      oximetry, to detect respiratory efforts, to measure the airflow, and to record snoring
      episodes. Additionally, HR was continually measured by the analysis of pulse waves by
      oximetry. Finally, brain and muscle activities were monitored by electrodes, and oxygen
      desaturation (O2D) was defined as the amount of reduction in O2S at 4%/h.

      Echocardiography All subjects performed the two-dimensional color Doppler echocardiogram
      (iE33® - Philips Electronics, Netherlands) before the CPET. Final systolic and diastolic
      diameters of the left ventricle and the diastolic thickness of the posterior wall of the left
      ventricle were measured from the short-axis view, and ejection fraction was obtained from
      these measures. This exam was conducted by an experienced cardiologist, who was blinded to
      group allocation.

      Sleep Quality The subjective sleep quality was assessed by the Pittsburgh Sleep Quality
      Index, which consists of 19 questions grouped into 7 different components (subjective sleep
      quality, sleep latency, sleep duration, sleep efficiency, sleep disorders, use of
      medications, and diurnal dysfunction). The classifications depended upon the scores reached
      in each question (from 0 to 3); ranging from 0 - 4: good subjective sleep quality; 5 - 10:
      bad subjective sleep quality; and 11 or higher: indicates the presence of at least one sleep
      disorder.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The participants were divided into two groups: (1) hypertension without OSA (NO-OSA group; AHI < 5 events/h; n = 15) and (2) hypertension with OSA (OSA group: AHI ≥ 15 events/h; n = 13).
primary purpose: Screening
masking: Double (Participant, Investigator)
masking description: The investigator did not have access to the exams that the volunteers realized, either they have access to what they were doing or the order of the exams.
measure: Apnea-Hypopnea Index
time frame: A entire night sleep, an average of 8 yours.
description: The OSA diagnose was confirmed by the apnea/hypopnea index (AHI) and classified as follows: AHI < 5 events/h, absence of OSA; 5 ≤ AHI ≤ 15 events/h, low OSA; 15 ≤ AHI ≤ 30 events/h, moderate OSA; AHI > 30 events/h, severe OSA.
measure: Oxygen Consumption
time frame: A entire procedure (approximately 10 minutes)
description: Following a 5-min warm-up against no resistance (0 W), the work rate was increased using a ramp protocol (5-10 W.min-1) until maximum exercise tolerance. Verbal encouragements were given during the CPET to ensure maximal effort.
arm group label: Cardiopulmonary Exercise Test Protocol
arm group type: Experimental
description: All subjects performed an incremental cardiopulmonary exercise test (CPET) to maximum exercise tolerance. All the procedures were performed in agreement with the American Thoracic Society/American College of Chest Physicians guidelines for cycle ergometer tests.
arm group label: Polysomnography Assessment
arm group type: Experimental
description: All hypertensive subjects were submitted to a polysomnography exam to diagnose OSA. The OSA diagnose was confirmed by the apnea/hypopnea index (AHI) and classified as follows: AHI < 5 events/h, absence of OSA; 5 ≤ AHI ≤ 15 events/h, low OSA; 15 ≤ AHI ≤ 30 events/h, moderate OSA; AHI > 30 events/h, severe OSA.
intervention type: Diagnostic Test
intervention name: Cardiopulmonary Exercise Test Protocol
description: The CPET was performed in a cycle ergometer with electromagnetic braking using an Inbrasport (Inbrasport, Porto Alegre, Rio Grande do Sul, Brazil). Following a 5-min warm-up against no resistance (0 W), the work rate was increased using a ramp protocol (5-10 W.min-1) until maximum exercise tolerance. Verbal encouragements were given during the CPET to ensure maximal effort.
arm group label: Cardiopulmonary Exercise Test Protocol
arm group label: Polysomnography Assessment
intervention type: Diagnostic Test
intervention name: Polysomnography Assessment
description: The polysomnography assessment was carried out during an entire night of sleep in the participant's residence with no use of sedatives. The variables were monitored by an Embletta portable respiratory monitor (Embla, Embletta® Gold, EUA), previously validated, and in agreement with manufacturer's instructions. The Embletta monitor was capable to monitor continuously the pulse oximetry, to detect respiratory efforts, to measure the airflow, and to record snoring episodes. Additionally, HR was continually measured by the analysis of pulse waves by oximetry. Finally, brain and muscle activities were monitored by electrodes and oxygen desaturation (O2D) was defined as the amount of reduction in O2S in 4%/h.
arm group label: Cardiopulmonary Exercise Test Protocol
arm group label: Polysomnography Assessment
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Bruno Barbosa, Master
role: Principal Investigator
affiliation: Centro Universitário de João Pessoa
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Paraíba
investigator full name: Bruno Teixeira Barbosa
investigator title: Assistant Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Hypertension
sharing ipd: No