<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/NCT03029767</url>
  </required_header>
  <id_info>
    <org_study_id>213.55.94.37</org_study_id>
    <nct_id>NCT03029767</nct_id>
  </id_info>
  <brief_title>Effect of Exercise on Selected Anthropometric,Biochemical and Physiological Variables Among Hypertensive Patients</brief_title>
  <official_title>Effect of Aerobic and Resistance Exercise on Selected Anthropometric Biochemical and Physiological Variables Among Hypertensive Patients in Hawassa University Referral Hospital, Southern Ethiopia: a Parallel Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mekelle University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mekelle University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypertension is the most common risk factor for development of stroke, congestive heart&#xD;
      failure chronic kidney disease, and coronary artery disease in Sub Saharan Africa. The&#xD;
      prevalence of hypertension will increase by 2025 in most parts of the world including&#xD;
      Ethiopia according to World Health Organization.&#xD;
&#xD;
      Physical inactivity has been identified as a stronger predictor of chronic diseases such as&#xD;
      hypertension. Exercise as a lifestyle modification is beneficial to a wide variety of health&#xD;
      conditions, specific to hypertension; the benefits of exercise have been promoted by a number&#xD;
      of organizations and agencies including World Health Organization.&#xD;
&#xD;
      According to the knowledge of the investigator there are no research works in relation to&#xD;
      aerobic and resistance exercise effects among hypertensive patients generally in Ethiopia,&#xD;
      and particularly in the area selected for the present research. Therefore the aim of this&#xD;
      study is to assess the effect of aerobic and resistance exercises on selected anthropometric,&#xD;
      biochemical and physiological variables among hypertensive patients in Hawassa University&#xD;
      Referral Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For eligible participants the requirements of the study will be explained and agree&#xD;
      voluntarily to undergo the training and testing program. During orientation for each&#xD;
      participant the risks, purpose, procedures and confidentiality of the requirement of the&#xD;
      experiment testing as well as training protocol will be explained thoroughly prior to their&#xD;
      written informed consent in their local language, and they have a full right to refuse from&#xD;
      participating in this research or they have also the full right to withdraw from this study&#xD;
      at any time they wish.&#xD;
&#xD;
      After acquisition of informed consent and exclusion criteria eligible participants will be&#xD;
      randomized to one of four groups. Sequence allocation will be done by an individual who do&#xD;
      not know and have no contact with the study participants .&#xD;
&#xD;
      Statistical analyses will be done using Statistical Package for Social Science (SPSS Version&#xD;
      20). One-way analyses of variance (ANOVA) will be used to assess differences between initial&#xD;
      values of the four groups on all the variables measured. In addition, the effect of the&#xD;
      experimental treatments on the anthropometric, biochemical and physiological variables will&#xD;
      be examined by using two-way analysis of variance (ANOVA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2017</start_date>
  <completion_date type="Actual">June 17, 2017</completion_date>
  <primary_completion_date type="Actual">June 17, 2017</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>Effect of aerobic exercise training (as intervention measures) on resting systolic blood pressure will be assessed.</measure>
    <time_frame>[ Time Frame: sixteen weeks ]</time_frame>
    <description>Change rates of systolic blood pressure among intervention and control groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of combined aerobic and resistance training on the reduction of body mass index among the hypertensive patients will be assessed</measure>
    <time_frame>[ Time Frame: Sixteen weeks ]</time_frame>
    <description>Body mass index reduction changes among intervention and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of combined aerobic and resistance training on the increasement of HDL-c level among the hypertensive patients will be assessed</measure>
    <time_frame>[ Time Frame: Sixteen weeks ]</time_frame>
    <description>HDL-C level changes among intervention and control groups</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Aerobic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic exercise training will be carried out as an intervention activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistance exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resistance exercise training will be conducted as an intervention activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerobic and resistance exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic and resistance training will be implemented</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>standard or usual activity carried out.Additional intervention will not be given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic exercise .</intervention_name>
    <description>The aerobic exercise group will perform brisk walking. Intensity of the aerobic exercise program will be progressively increased throughout the 16-week program. Intensity of aerobic exercise will be 40-65% of maximum heart rate , which is low to moderate.Duration of each session will be 45 minutes. Aerobic exercise will be performed 3 days per week.</description>
    <arm_group_label>Aerobic exercise</arm_group_label>
    <other_name>Non pharmacological</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance exercise</intervention_name>
    <description>The resistance exercise group will perform 8 different exercises. Frequency of exercises per week is 3 days and duration of each exercise session is 45minutes. Interval rest among different exercises is 1minute.The intensity and repetition of resistance exercises is progressive. Participants will be exercised at 30% intensity (low intensity) for upper body and 50% intensity (moderate intensity) repetition voluntary maximum for lower body.&#xD;
Progressive, dynamic and rhythmical, alternative to upper-body and lower-body works and circuit resistance training of low to moderate intensity exercises will be executed.</description>
    <arm_group_label>Resistance exercise</arm_group_label>
    <other_name>Non pharmacological</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic and resistance exercise</intervention_name>
    <description>The aerobic and resistance exercise group will perform 23 minutes aerobic exercises and 22 minutes resistance exercises. The exercises will be performed three days per week . Intensity of aerobic and resistance exercise group for aerobic and resistance exercises are similar with intensity of aerobic group and resistance group exercises respectively.</description>
    <arm_group_label>Aerobic and resistance exercise</arm_group_label>
    <other_name>Non pharmacological</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertensive patients who will give a written consent to participate in the study&#xD;
&#xD;
          -  Hypertensive patients who are going to stay in the area throughout the study period&#xD;
&#xD;
          -  Hypertensive patients between the age range of 31 and 45 years old with essential mild&#xD;
             hypertension (systolic blood pressure between 140-159 mmHg and diastolic blood&#xD;
             pressure between 90 and 99 mm Hg)&#xD;
&#xD;
          -  participants not participated in structured physical exercises for previous 3 months&#xD;
&#xD;
          -  patients who are on single anti-hypertensive medication or unmedicated&#xD;
&#xD;
          -  Body mass index(BMI) 18.5kg/m2-29.9kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participants who involved in any exercise program prior to study&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  women who are taking contraceptive drugs&#xD;
&#xD;
          -  Participants who are taking lipid lowering drugs&#xD;
&#xD;
          -  participants who are taking any medications except single anti-hypertensive medication&#xD;
&#xD;
          -  participants with organ damage,&#xD;
&#xD;
          -  secondary hypertension&#xD;
&#xD;
          -  patients with known liver problem&#xD;
&#xD;
          -  patients with renal disease ,heart disease, brain disease&#xD;
&#xD;
          -  participants with age less than 31 and greater than 45 years&#xD;
&#xD;
          -  diabetic patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>31 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mitiku D Abebe, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>College of Natural and Computational Sciences,Mekelle University Mekelle University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Soumatra K Mondal, PhD</last_name>
    <role>Study Director</role>
    <affiliation>College of Natural and Computational Sciences, Mekelle University Mekelle University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mahmud Ab Mahmud, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>College of Health Sciences, Mekelle University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Palani B Kumar, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>College of Natural and Computational Sciences, Mekelle University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hawassa University Referral Hospital</name>
      <address>
        <city>Hawassa</city>
        <state>Southern Nations Nationality Peoples Region</state>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ethiopia</country>
  </location_countries>
  <results_reference>
    <citation>1. Addo J, Smeeth L, Leon DA. Hypertension in sub Saharan Africa: a systematic review. Hypertension. 50(6):1012-8,2007. [PubMed/17954720] 2. Bacon SL, Sherwood A, Hinderliter A, Blumenthal JA. Effects of exercise, diet and weight loss on high blood pressure. Sports Medicine 35 (5), 307-316,2004. [PubMed/15107009] 3. Banz W, Maher M, Thompson W. Effects of resistance versus aerobic training on coronary artery disease risk factors. Exp Biol Med. 228(4):434-40,2003. [PubMed/12671188] 4. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, Jone JR, Materson BJ, Oparil S, Wright JT, Roccella EJ. Seventh Report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure: the JNC 7 report.JAMA 289 (19):2560-72, 2003. [PubMed/12748199] 5. Cornelissen V, Fagard R. Effect of resistance training on resting blood pressure: a meta- analysis of randomized controlled trials. J Hypertens 23(2):251-9, 2005. [PubMed/15662209] 6. Cornelissen V, Fagard R. Effects of endurance training on blood pressure, blood pressure-regulating mechanisms, and cardiovascular risk factors. Hypertension 46 (4):667-75, 2005[PubMed/16157788] 7. Fagard RH, Cornelissen VA. Effect of exercise on blood pressure control in Hypertensive patients. Eur J Cardiovasc Prev Rehabil. 14:12-7, 2007. [PubMed/17301622] 8. Fagard RH. Exercise characteristics and the blood pressure response to dynamic physical training. Med Sci Sports Exerc 33: S484-492,2001. [PubMed/11427774] 9. Guidry, M.A., Blanchard ,B.E., Thompson ,P.D., Maresh, C.M., Seip, R.L., &amp;Taylor, A.L. (2006). The influence of short and long duration on the blood pressure response to an acute bout of dynamic exercise. Am Heart J 151:1322.e5-12. [PubMed/16781245] 10. World Health Organization . Obesity: Preventing and Managing the Global Epidemic. WHO Technical Report 2000( 894). Geneva. 11. World Health Organization (2002). The world health report 2002: reducing risks, promoting healthy life. WHO, Geneva. 12. World Health Organization . The world health report 2002: reducing risks, promoting healthy life. WHO, Geneva 2000. 13. World Health Organization (WHO). A global brief on hypertension world health day. Geneva 2013. 14. Ha CH, So WY. Effects of combined exercise training on body composition and metabolic syndrome factors. Iran J Public Health. 41 (8):20-6,2012.[ PMC3469031]</citation>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>November 22, 2018</last_update_submitted>
  <last_update_submitted_qc>November 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mekelle University</investigator_affiliation>
    <investigator_full_name>Mitiku Daimo</investigator_full_name>
    <investigator_title>Mitiku Daimo PhD scholar</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Anthropometry</keyword>
  <keyword>Aerobic exercise</keyword>
  <keyword>Resistance exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Abstract of the study and consent format</ipd_description>
  </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/NCT03029767
org study id: 213.55.94.37
nct id: NCT03029767
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Hypertension is the most common risk factor for development of stroke, congestive heart
      failure chronic kidney disease, and coronary artery disease in Sub Saharan Africa. The
      prevalence of hypertension will increase by 2025 in most parts of the world including
      Ethiopia according to World Health Organization.

      Physical inactivity has been identified as a stronger predictor of chronic diseases such as
      hypertension. Exercise as a lifestyle modification is beneficial to a wide variety of health
      conditions, specific to hypertension; the benefits of exercise have been promoted by a number
      of organizations and agencies including World Health Organization.

      According to the knowledge of the investigator there are no research works in relation to
      aerobic and resistance exercise effects among hypertensive patients generally in Ethiopia,
      and particularly in the area selected for the present research. Therefore the aim of this
      study is to assess the effect of aerobic and resistance exercises on selected anthropometric,
      biochemical and physiological variables among hypertensive patients in Hawassa University
      Referral Hospital.
For eligible participants the requirements of the study will be explained and agree
      voluntarily to undergo the training and testing program. During orientation for each
      participant the risks, purpose, procedures and confidentiality of the requirement of the
      experiment testing as well as training protocol will be explained thoroughly prior to their
      written informed consent in their local language, and they have a full right to refuse from
      participating in this research or they have also the full right to withdraw from this study
      at any time they wish.

      After acquisition of informed consent and exclusion criteria eligible participants will be
      randomized to one of four groups. Sequence allocation will be done by an individual who do
      not know and have no contact with the study participants .

      Statistical analyses will be done using Statistical Package for Social Science (SPSS Version
      20). One-way analyses of variance (ANOVA) will be used to assess differences between initial
      values of the four groups on all the variables measured. In addition, the effect of the
      experimental treatments on the anthropometric, biochemical and physiological variables will
      be examined by using two-way analysis of variance (ANOVA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Effect of aerobic exercise training (as intervention measures) on resting systolic blood pressure will be assessed.
time frame: [ Time Frame: sixteen weeks ]
description: Change rates of systolic blood pressure among intervention and control groups
measure: Effect of combined aerobic and resistance training on the reduction of body mass index among the hypertensive patients will be assessed
time frame: [ Time Frame: Sixteen weeks ]
description: Body mass index reduction changes among intervention and control groups
measure: Effect of combined aerobic and resistance training on the increasement of HDL-c level among the hypertensive patients will be assessed
time frame: [ Time Frame: Sixteen weeks ]
description: HDL-C level changes among intervention and control groups
arm group label: Aerobic exercise
arm group type: Experimental
description: Aerobic exercise training will be carried out as an intervention activity
arm group label: Resistance exercise
arm group type: Experimental
description: Resistance exercise training will be conducted as an intervention activity
arm group label: Aerobic and resistance exercise
arm group type: Experimental
description: Aerobic and resistance training will be implemented
arm group label: Control group
arm group type: No Intervention
description: standard or usual activity carried out.Additional intervention will not be given.
intervention type: Other
intervention name: Aerobic exercise .
description: The aerobic exercise group will perform brisk walking. Intensity of the aerobic exercise program will be progressively increased throughout the 16-week program. Intensity of aerobic exercise will be 40-65% of maximum heart rate , which is low to moderate.Duration of each session will be 45 minutes. Aerobic exercise will be performed 3 days per week.
arm group label: Aerobic exercise
other name: Non pharmacological
intervention type: Other
intervention name: Resistance exercise
description: The resistance exercise group will perform 8 different exercises. Frequency of exercises per week is 3 days and duration of each exercise session is 45minutes. Interval rest among different exercises is 1minute.The intensity and repetition of resistance exercises is progressive. Participants will be exercised at 30% intensity (low intensity) for upper body and 50% intensity (moderate intensity) repetition voluntary maximum for lower body.
Progressive, dynamic and rhythmical, alternative to upper-body and lower-body works and circuit resistance training of low to moderate intensity exercises will be executed.
arm group label: Resistance exercise
other name: Non pharmacological
intervention type: Other
intervention name: Aerobic and resistance exercise
description: The aerobic and resistance exercise group will perform 23 minutes aerobic exercises and 22 minutes resistance exercises. The exercises will be performed three days per week . Intensity of aerobic and resistance exercise group for aerobic and resistance exercises are similar with intensity of aerobic group and resistance group exercises respectively.
arm group label: Aerobic and resistance exercise
other name: Non pharmacological
criteria: 
gender: All
minimum age: 31 Years
maximum age: 45 Years
healthy volunteers: No
last name: Mitiku D Abebe, MSc
role: Principal Investigator
affiliation: College of Natural and Computational Sciences,Mekelle University Mekelle University
last name: Soumatra K Mondal, PhD
role: Study Director
affiliation: College of Natural and Computational Sciences, Mekelle University Mekelle University
last name: Mahmud Ab Mahmud, PhD
role: Study Chair
affiliation: College of Health Sciences, Mekelle University
last name: Palani B Kumar, PhD
role: Study Chair
affiliation: College of Natural and Computational Sciences, Mekelle University
facility: 
country: Ethiopia
citation: 1. Addo J, Smeeth L, Leon DA. Hypertension in sub Saharan Africa: a systematic review. Hypertension. 50(6):1012-8,2007. [PubMed/17954720] 2. Bacon SL, Sherwood A, Hinderliter A, Blumenthal JA. Effects of exercise, diet and weight loss on high blood pressure. Sports Medicine 35 (5), 307-316,2004. [PubMed/15107009] 3. Banz W, Maher M, Thompson W. Effects of resistance versus aerobic training on coronary artery disease risk factors. Exp Biol Med. 228(4):434-40,2003. [PubMed/12671188] 4. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, Jone JR, Materson BJ, Oparil S, Wright JT, Roccella EJ. Seventh Report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure: the JNC 7 report.JAMA 289 (19):2560-72, 2003. [PubMed/12748199] 5. Cornelissen V, Fagard R. Effect of resistance training on resting blood pressure: a meta- analysis of randomized controlled trials. J Hypertens 23(2):251-9, 2005. [PubMed/15662209] 6. Cornelissen V, Fagard R. Effects of endurance training on blood pressure, blood pressure-regulating mechanisms, and cardiovascular risk factors. Hypertension 46 (4):667-75, 2005[PubMed/16157788] 7. Fagard RH, Cornelissen VA. Effect of exercise on blood pressure control in Hypertensive patients. Eur J Cardiovasc Prev Rehabil. 14:12-7, 2007. [PubMed/17301622] 8. Fagard RH. Exercise characteristics and the blood pressure response to dynamic physical training. Med Sci Sports Exerc 33: S484-492,2001. [PubMed/11427774] 9. Guidry, M.A., Blanchard ,B.E., Thompson ,P.D., Maresh, C.M., Seip, R.L., &Taylor, A.L. (2006). The influence of short and long duration on the blood pressure response to an acute bout of dynamic exercise. Am Heart J 151:1322.e5-12. [PubMed/16781245] 10. World Health Organization . Obesity: Preventing and Managing the Global Epidemic. WHO Technical Report 2000( 894). Geneva. 11. World Health Organization (2002). The world health report 2002: reducing risks, promoting healthy life. WHO, Geneva. 12. World Health Organization . The world health report 2002: reducing risks, promoting healthy life. WHO, Geneva 2000. 13. World Health Organization (WHO). A global brief on hypertension world health day. Geneva 2013. 14. Ha CH, So WY. Effects of combined exercise training on body composition and metabolic syndrome factors. Iran J Public Health. 41 (8):20-6,2012.[ PMC3469031]
responsible party type: Principal Investigator
investigator affiliation: Mekelle University
investigator full name: Mitiku Daimo
investigator title: Mitiku Daimo PhD scholar
mesh term: Hypertension
sharing ipd: Yes
ipd description: Abstract of the study and consent format