<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/NCT02200926</url>
  </required_header>
  <id_info>
    <org_study_id>BSangthong</org_study_id>
    <secondary_id>change1me</secondary_id>
    <nct_id>NCT02200926</nct_id>
  </id_info>
  <brief_title>Non-pharmacological Treatment for Essential Isolated Systolic Hypertension in Elderly</brief_title>
  <official_title>Effects of Slow Loaded and Unloaded Breathing Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khon Kaen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Khon Kaen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The previous studies used the slow loaded breathing device for breathing training (Jones et&#xD;
      al., 2010). It has been shown that slow loaded breathing training can reduce resting blood&#xD;
      pressure and heart rate in essential hypertensive patients. However, this has not been&#xD;
      studied in elderly with essential isolated systolic hypertensive patients. Not only highest&#xD;
      prevalence of hypertension in Thailand was found in elderly but also physiological changes in&#xD;
      the elderly are cause of interest in this special population. It has many advantages to use a&#xD;
      slow loaded breathing training in elderly people. Firstly, it is low technology and easily&#xD;
      implemented at home. Secondly, it can be practiced almost anytime and anywhere. Thirdly, the&#xD;
      orthopedic complications of slow loaded breathing training are minimal. Finally, slow loaded&#xD;
      breathing training may be enhancing cardiopulmonary function and other fitness traits, but it&#xD;
      out of scope of this study. Moreover, slow loaded breathing exercise by itself should not&#xD;
      result in any metabolic adaptation of skeletal muscles, such as the forearm, which had not&#xD;
      been trained. If slow loaded breathing training modified some central component of the&#xD;
      pressor reflex pathway in a way that single muscle training might work, as suggested above,&#xD;
      then loaded breathing training would have a modulating effect on the pressor responses of&#xD;
      muscles that had not been trained.&#xD;
&#xD;
      We, therefore, aim to study the effect of slow loaded breathing training by using Breathmax&#xD;
      on blood pressure at rest and exercise in elderly with essential isolated systolic&#xD;
      hypertension and also investigate the autonomic function and others that may be involved with&#xD;
      the changed blood pressure in elderly with essential isolated systolic hypertension. We&#xD;
      hypothesized that slow loaded and unloaded breathing training could reduce resting and&#xD;
      exercising blood pressure in elderly with essential isolated systolic hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All subjects will be trained for blood pressure and heart rate measurement at home by using a&#xD;
      digital arm blood pressure monitoring for 2 weeks control periods before start breathing&#xD;
      training. After 2 weeks, subjects in both breathing training groups will trained to inspire&#xD;
      deeply against the resistance setting by using Breathmax at the loaded of 18 centimeter of&#xD;
      water (cmH2O) and 0 cmH2O (no resistance) with breathing frequency control at 6&#xD;
      breaths/minute in loaded breathing (LB) and unloaded breathing (ULB) group, respectively.&#xD;
      They will rest for 5 seconds after every 6 deep breathing. Breathing pattern will be&#xD;
      controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10&#xD;
      sec). The paced breathing will be practice using metronome at the laboratory until the&#xD;
      subjects can do independently without metronome. The breathing was performed normally in&#xD;
      control groups (C). The training program will be performed at home for 30 minutes/day, 7&#xD;
      days/week for 8 weeks.&#xD;
&#xD;
      After 8 weeks of breathing training, the sustainability of breathing training effect will be&#xD;
      assessed. Subjects in both breathing training groups (LB and ULB) will be stop breathing&#xD;
      training with Breathmax and change to breathing normally. In contrast with the subjects in&#xD;
      control group, they will be divided to 2 subgroups. The first subgroup performed loaded&#xD;
      breathing training at the loaded of 18 cmH2O. The another subgroup performed unloaded&#xD;
      breathing training at the loaded of 0 cmH2O. Breathing frequency will be control at 6&#xD;
      breaths/minute in both subgroups. The training program will be performed at home for 30&#xD;
      minutes/day, 7 days/week for 8 weeks.&#xD;
&#xD;
      Data collection will be carried out for 4 times: (1) before control, (2) before training, (3)&#xD;
      after training and (4) after stop training. All measurement will be done in the&#xD;
      cardiovascular laboratory room, department of physical therapy, faculty of associated medical&#xD;
      sciences. In addition, self measurement of blood pressure and heart rate will be conducted at&#xD;
      home every morning after getting up at the same time throughout the study (from week 0 to&#xD;
      18).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resting blood pressure</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse wave velocity</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise pressure response</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac output</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flow-mediated dilatation of brachial artery</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forearm limb blood flow</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Systolic Essential Hypertension</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The breathing was performed normally in this groups.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Loaded breathing training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects will trained to inspire deeply against the resistance setting by using BreathMAX® at the loaded of 18 cmH2O with breathing frequency control at 6 breaths/minute. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unloaded breathing training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects will trained to inspire deeply (no resistance) with breathing frequency control at 6 breaths/minute. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Loaded breathing training</intervention_name>
    <description>7 days/weeks, for 8 weeks</description>
    <arm_group_label>Loaded breathing training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Unloaded breathing training</intervention_name>
    <description>7 days/week, for 8 weeks</description>
    <arm_group_label>Unloaded breathing training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>7 days/week, for 8 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Essential isolated systolic hypertension (stage I- II, based on recommendations of&#xD;
             JNC-VII)&#xD;
&#xD;
          -  Good communication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Essential hypertension stage III or secondary hypertension&#xD;
&#xD;
          -  History of respiratory disease, heart disease, renal disease, blindness, deafness and&#xD;
             cerebrovascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjarat Sangthong, M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of associated medical science, Khon Kaen University, thailand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of associated medical science, Khon Kaen University</name>
      <address>
        <city>Muang</city>
        <state>Khon Kaen</state>
        <zip>40000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <results_reference>
    <citation>Jones CU, Sangthong B, Pachirat O. An inspiratory load enhances the antihypertensive effects of home-based training with slow deep breathing: a randomised trial. J Physiother. 2010;56(3):179-86. doi: 10.1016/s1836-9553(10)70023-0. Erratum In: J Physiother. 2010;56(4):221.</citation>
    <PMID>20795924</PMID>
  </results_reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>September 8, 2016</last_update_submitted>
  <last_update_submitted_qc>September 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Khon Kaen University</investigator_affiliation>
    <investigator_full_name>Benjarat Sangthong</investigator_full_name>
    <investigator_title>Cardiopulmonay research, Faculty of associated medical science</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Essential Hypertension</mesh_term>
    <mesh_term>Systolic Murmurs</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02200926
org study id: BSangthong
secondary id: change1me
nct id: NCT02200926
lead sponsor: 
has dmc: Yes
The previous studies used the slow loaded breathing device for breathing training (Jones et
      al., 2010). It has been shown that slow loaded breathing training can reduce resting blood
      pressure and heart rate in essential hypertensive patients. However, this has not been
      studied in elderly with essential isolated systolic hypertensive patients. Not only highest
      prevalence of hypertension in Thailand was found in elderly but also physiological changes in
      the elderly are cause of interest in this special population. It has many advantages to use a
      slow loaded breathing training in elderly people. Firstly, it is low technology and easily
      implemented at home. Secondly, it can be practiced almost anytime and anywhere. Thirdly, the
      orthopedic complications of slow loaded breathing training are minimal. Finally, slow loaded
      breathing training may be enhancing cardiopulmonary function and other fitness traits, but it
      out of scope of this study. Moreover, slow loaded breathing exercise by itself should not
      result in any metabolic adaptation of skeletal muscles, such as the forearm, which had not
      been trained. If slow loaded breathing training modified some central component of the
      pressor reflex pathway in a way that single muscle training might work, as suggested above,
      then loaded breathing training would have a modulating effect on the pressor responses of
      muscles that had not been trained.

      We, therefore, aim to study the effect of slow loaded breathing training by using Breathmax
      on blood pressure at rest and exercise in elderly with essential isolated systolic
      hypertension and also investigate the autonomic function and others that may be involved with
      the changed blood pressure in elderly with essential isolated systolic hypertension. We
      hypothesized that slow loaded and unloaded breathing training could reduce resting and
      exercising blood pressure in elderly with essential isolated systolic hypertension.
All subjects will be trained for blood pressure and heart rate measurement at home by using a
      digital arm blood pressure monitoring for 2 weeks control periods before start breathing
      training. After 2 weeks, subjects in both breathing training groups will trained to inspire
      deeply against the resistance setting by using Breathmax at the loaded of 18 centimeter of
      water (cmH2O) and 0 cmH2O (no resistance) with breathing frequency control at 6
      breaths/minute in loaded breathing (LB) and unloaded breathing (ULB) group, respectively.
      They will rest for 5 seconds after every 6 deep breathing. Breathing pattern will be
      controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10
      sec). The paced breathing will be practice using metronome at the laboratory until the
      subjects can do independently without metronome. The breathing was performed normally in
      control groups (C). The training program will be performed at home for 30 minutes/day, 7
      days/week for 8 weeks.

      After 8 weeks of breathing training, the sustainability of breathing training effect will be
      assessed. Subjects in both breathing training groups (LB and ULB) will be stop breathing
      training with Breathmax and change to breathing normally. In contrast with the subjects in
      control group, they will be divided to 2 subgroups. The first subgroup performed loaded
      breathing training at the loaded of 18 cmH2O. The another subgroup performed unloaded
      breathing training at the loaded of 0 cmH2O. Breathing frequency will be control at 6
      breaths/minute in both subgroups. The training program will be performed at home for 30
      minutes/day, 7 days/week for 8 weeks.

      Data collection will be carried out for 4 times: (1) before control, (2) before training, (3)
      after training and (4) after stop training. All measurement will be done in the
      cardiovascular laboratory room, department of physical therapy, faculty of associated medical
      sciences. In addition, self measurement of blood pressure and heart rate will be conducted at
      home every morning after getting up at the same time throughout the study (from week 0 to
      18).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Resting blood pressure
time frame: 4 months
measure: Heart rate
time frame: 4 months
measure: Pulse wave velocity
time frame: 4 months
measure: Exercise pressure response
time frame: 4 months
measure: Heart rate variability
time frame: 4 months
measure: cardiac output
time frame: 4 months
measure: Flow-mediated dilatation of brachial artery
time frame: 4 months
measure: Forearm limb blood flow
time frame: 4 months
arm group label: Placebo
arm group type: Experimental
description: The breathing was performed normally in this groups.
arm group label: Loaded breathing training
arm group type: Experimental
description: subjects will trained to inspire deeply against the resistance setting by using BreathMAX® at the loaded of 18 cmH2O with breathing frequency control at 6 breaths/minute. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks.
arm group label: Unloaded breathing training
arm group type: Experimental
description: subjects will trained to inspire deeply (no resistance) with breathing frequency control at 6 breaths/minute. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks.
intervention type: Other
intervention name: Loaded breathing training
description: 7 days/weeks, for 8 weeks
arm group label: Loaded breathing training
intervention type: Other
intervention name: Unloaded breathing training
description: 7 days/week, for 8 weeks
arm group label: Unloaded breathing training
intervention type: Other
intervention name: Placebo
description: 7 days/week, for 8 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
last name: Benjarat Sangthong, M.Sc.
role: Principal Investigator
affiliation: Faculty of associated medical science, Khon Kaen University, thailand
facility: 
country: Thailand
citation: Jones CU, Sangthong B, Pachirat O. An inspiratory load enhances the antihypertensive effects of home-based training with slow deep breathing: a randomised trial. J Physiother. 2010;56(3):179-86. doi: 10.1016/s1836-9553(10)70023-0. Erratum In: J Physiother. 2010;56(4):221.
PMID: 20795924
responsible party type: Principal Investigator
investigator affiliation: Khon Kaen University
investigator full name: Benjarat Sangthong
investigator title: Cardiopulmonay research, Faculty of associated medical science
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Systolic Murmurs
sharing ipd: Undecided