<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/NCT03757169</url>
  </required_header>
  <id_info>
    <org_study_id>isopress03</org_study_id>
    <nct_id>NCT03757169</nct_id>
  </id_info>
  <brief_title>Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA)</brief_title>
  <acronym>OSA</acronym>
  <official_title>Effect of Isometric Hand Grip Training on Blood Pressure of Hypertensive Patients With Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pernambuco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pernambuco</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>
      Obstructive sleep apnea (OSA) is a common clinical condition, involving the development of&#xD;
      arterial hypertension. A Meta analysis study have shown that isometric hand grip training&#xD;
      promotes blood pressure reduction. It is going to be conducted a clinical trail to determine&#xD;
      the effects of hand grip training in OSA patients to change the arterial hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: obstructive sleep apnea (OSA) is a common clinical condition, involving the&#xD;
      development of arterial hypertension. Meta analysis study have shown that isometric hand grip&#xD;
      strength promotes blood pressure reduction, and its reduction is higher than that observed&#xD;
      after aerobic training. Objective: to analyze the effects of the isometric hand grip on blood&#xD;
      pressure changes of patients with uncontrolled arterial hypertension with OSA. Methods: a&#xD;
      randomized controlled trial involving 18 adults with OSA and uncontrolled arterial&#xD;
      hypertension of both sexes, randomized between control group (receive general guidelines) and&#xD;
      hand grip group. 12 weeks of training with load equivalent to 30% of maximum voluntary&#xD;
      capacity was performed. All participants will be submitted for evaluation of blood pressure&#xD;
      (BP) central and brachial, pulse wave velocity, full polysomnography,before and after the&#xD;
      study protocol (the change from the baseline at 12 weeks). Expected results: the authors&#xD;
      believe that hand grip training can change (reduce) blood pressure in patient with OSA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 17, 2017</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">December 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>There are two randomized groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change at ambulatory blood pressure monitoring</measure>
    <time_frame>Change from the baseline ambulatory blood pressure monitoring at 12 weeks</time_frame>
    <description>24h of monitoring blood pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change at blood pressure</measure>
    <time_frame>Change from the baseline brachial blood pressure at 12 weeks</time_frame>
    <description>Three measurement of brachial blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chance at Apnea-Hypopnea Index (AHI)</measure>
    <time_frame>Change from the baseline AHI at 12 weeks</time_frame>
    <description>Index obtained by the Polysomnography to detect the level of Apnea-Hypopnea Index. The higher level, the worse the disease. The value of the AHI between 5 to 15 events/hour means mild disease. AHI between 16 to 30 events/hour means moderate disease, and more than 30 events/hour means severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change at Pulse wave velocity</measure>
    <time_frame>Change from the baseline pulse wave velocity at 12 weeks</time_frame>
    <description>To evaluate the pulse wave velocity (femoral, carotid and aortic) to detect the occurrence of arterial disease.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Verbal informations about the disease, and exercise behavior, and nutrition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hand grip group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three supervised sessions por week: 4 series (2 at each arm) of two minutes of isometric hand grip contraction at 30% of maximal voluntary contraction. Between series there will be two minutes to rest.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hand grip isometric contraction</intervention_name>
    <description>The patients at the Hand Grip group will perform 12 weeks of hand grip exercises, three times/week for 16 minutes with time to rest.</description>
    <arm_group_label>Hand grip group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>The patients will receive verbal orientations about the OSA and the arterial hypertension.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  OSA diagnose based on polysomnography,&#xD;
&#xD;
          -  Apnea-Hypopnea Index (AHI) &gt; 5,&#xD;
&#xD;
          -  arterial hypertension (systolic arterial pressure &gt; 140 mmHg or diastolic arterial&#xD;
             pressure &gt; 90 mmHg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other heart disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Flávio MD Andrade, Ms</last_name>
    <phone>+55 81 99635 5417</phone>
    <email>flaviomacielandrade@yahoo.com.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pronto Socorro Cardiológico de Pernambuco - Procape</name>
      <address>
        <city>Recife</city>
        <state>PE</state>
        <zip>50.100-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rodrigo Pedrosa, PhD</last_name>
      <phone>+55 81 31817179</phone>
      <email>rppedrosa@terra.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Flávio MD Andrade, Ms</last_name>
      <phone>+ 55 81 99635 54 17</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pernambuco</investigator_affiliation>
    <investigator_full_name>Rodrigo Pinto Pedrosa</investigator_full_name>
    <investigator_title>Head of sleep laboratory and heart emergency room of Pernambuco , Principal Investigator.</investigator_title>
  </responsible_party>
  <keyword>training</keyword>
  <keyword>hand grip</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>
  </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/NCT03757169
org study id: isopress03
nct id: NCT03757169
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obstructive sleep apnea (OSA) is a common clinical condition, involving the development of
      arterial hypertension. A Meta analysis study have shown that isometric hand grip training
      promotes blood pressure reduction. It is going to be conducted a clinical trail to determine
      the effects of hand grip training in OSA patients to change the arterial hypertension.
Background: obstructive sleep apnea (OSA) is a common clinical condition, involving the
      development of arterial hypertension. Meta analysis study have shown that isometric hand grip
      strength promotes blood pressure reduction, and its reduction is higher than that observed
      after aerobic training. Objective: to analyze the effects of the isometric hand grip on blood
      pressure changes of patients with uncontrolled arterial hypertension with OSA. Methods: a
      randomized controlled trial involving 18 adults with OSA and uncontrolled arterial
      hypertension of both sexes, randomized between control group (receive general guidelines) and
      hand grip group. 12 weeks of training with load equivalent to 30% of maximum voluntary
      capacity was performed. All participants will be submitted for evaluation of blood pressure
      (BP) central and brachial, pulse wave velocity, full polysomnography,before and after the
      study protocol (the change from the baseline at 12 weeks). Expected results: the authors
      believe that hand grip training can change (reduce) blood pressure in patient with OSA.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There are two randomized groups.
primary purpose: Treatment
masking: None (Open Label)
measure: Change at ambulatory blood pressure monitoring
time frame: Change from the baseline ambulatory blood pressure monitoring at 12 weeks
description: 24h of monitoring blood pressure
measure: Change at blood pressure
time frame: Change from the baseline brachial blood pressure at 12 weeks
description: Three measurement of brachial blood pressure
measure: Chance at Apnea-Hypopnea Index (AHI)
time frame: Change from the baseline AHI at 12 weeks
description: Index obtained by the Polysomnography to detect the level of Apnea-Hypopnea Index. The higher level, the worse the disease. The value of the AHI between 5 to 15 events/hour means mild disease. AHI between 16 to 30 events/hour means moderate disease, and more than 30 events/hour means severe disease.
measure: Change at Pulse wave velocity
time frame: Change from the baseline pulse wave velocity at 12 weeks
description: To evaluate the pulse wave velocity (femoral, carotid and aortic) to detect the occurrence of arterial disease.
arm group label: Control group
arm group type: Active Comparator
description: Verbal informations about the disease, and exercise behavior, and nutrition.
arm group label: Hand grip group
arm group type: Active Comparator
description: Three supervised sessions por week: 4 series (2 at each arm) of two minutes of isometric hand grip contraction at 30% of maximal voluntary contraction. Between series there will be two minutes to rest.
intervention type: Other
intervention name: Hand grip isometric contraction
description: The patients at the Hand Grip group will perform 12 weeks of hand grip exercises, three times/week for 16 minutes with time to rest.
arm group label: Hand grip group
intervention type: Other
intervention name: Control
description: The patients will receive verbal orientations about the OSA and the arterial hypertension.
arm group label: Control group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Flávio MD Andrade, Ms
phone: +55 81 99635 5417
email: flaviomacielandrade@yahoo.com.br
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Pernambuco
investigator full name: Rodrigo Pinto Pedrosa
investigator title: Head of sleep laboratory and heart emergency room of Pernambuco , Principal Investigator.
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive