<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/NCT04488341</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/002676</org_study_id>
    <nct_id>NCT04488341</nct_id>
  </id_info>
  <brief_title>Effect of Aerobic Exercises on Sex Hormones and Coagulation Factors in Postmenopausal Elderly Women</brief_title>
  <official_title>Effect of Aerobic Exercises on Sex Hormones and Coagulation Factors in Postmenopausal Elderly Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      PURPOSE:&#xD;
&#xD;
      to determine the effect of aerobic exercise training on sex hormones and coagulation factors&#xD;
      in postmenopausal elderly women&#xD;
&#xD;
      BACKGROUND:&#xD;
&#xD;
      Cardiovascular disease (CVD) is the largest cause of death in women, and the risk of&#xD;
      developing CVD increases after menopause . Because thrombosis is thought to be a cause of&#xD;
      most acute cardiovascular events, abnormalities in endogenous coagulation and fibrinolysis&#xD;
      may play an important role in the risk of an acute cardiovascular event. Aging is also&#xD;
      associated with adverse changes in both coagulation and fibrinolysis. For instance,&#xD;
      postmenopausal women exhibit higher fibrinogen levels and lower levels of endogenous&#xD;
      fibrinolysis. Physical activity and physical fitness have consistently been linked to lower&#xD;
      CVD rates in women. In fact, an inverse association between physical activity and total&#xD;
      mortality, as well as a 50% reduction in risk of myocardial infarction, has been observed in&#xD;
      physically active postmenopausal women. In addition to the numerous other benefits provided&#xD;
      by regular physical activity, one of the mechanisms mediating the cardioprotective effect may&#xD;
      be changes in the hemostatic system, particularly fibrinolysis&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
      Aerobic exercises may have no effect on sex hormones and coagulation factors in elderly&#xD;
      postmenopausal women&#xD;
&#xD;
      RESEARCH QUESTION:&#xD;
&#xD;
      Do aerobic exercises effect on sex hormones and coagulation factors in elderly postmenopausal&#xD;
      women in response to exercises?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is an interventional study in which 40 women estimated to enroll according to random&#xD;
      allocation and assigned into two groups equally. The study group will receive aerobic&#xD;
      exercises in addition to diet recommendations while the control group will receive diet&#xD;
      recommendations. the aerobic exercises time of session 40-50 min initial 10 min warm up&#xD;
      exercises on treadmill in low intensity and active phase 20- 30 min intensity will increase&#xD;
      until patient reach to target heart rate then intensity decrease until session will be ended&#xD;
      by cooling down phase for 10 min . The volunteers will perform exercises 3 times per week for&#xD;
      12 weeks .coagulation factors(Prothrombin time, Partial Thromboplastin Time , plasminogen&#xD;
      activator inhibitor-1 , fibrinogen and tissue plasminogen activator )will be measured and sex&#xD;
      hormones (estradiol ,testosterone. sex hormone binding globin ) pre and post intervention&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 20, 2020</start_date>
  <completion_date type="Anticipated">August 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 15, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>coagulation factors</measure>
    <time_frame>12 weeks</time_frame>
    <description>change of selected coagulation factors by blood analysis (plasminogen activator inhibitor-1 ,tissue plasminogen activator ,Prothrombin time ,Partial Thromboplastin time ,fibrinogen )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sex hormones</measure>
    <time_frame>12 weeks</time_frame>
    <description>change of (estradiol ,testosterone. sex hormone binding globin )</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>measuring weight in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>height</measure>
    <time_frame>12 weeks</time_frame>
    <description>measuring height in meters</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Coagulation Disorder</condition>
  <arm_group>
    <arm_group_label>aerobic exercises in addition to diet</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The study group will receive aerobic exercises in addition to diet recommendations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>diet recommendations</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>control group will receive diet recommendations</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>aerobic exercises in addition to diet recommendations</intervention_name>
    <description>aerobic exercises time of session 40-50 min initial 10 min warm up exercises on treadmill in low intensity and active phase 20- 30 min intensity will increase until patient reach to target heart rate then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercises 3 times per week for 12 weeks</description>
    <arm_group_label>aerobic exercises in addition to diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>diet recommendations</intervention_name>
    <description>control group will receive diet recommendations for 12 weeks</description>
    <arm_group_label>aerobic exercises in addition to diet</arm_group_label>
    <arm_group_label>diet recommendations</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • forty Postmenopausal women (60-70 y)&#xD;
&#xD;
               -  Body mass index (BMI) ranged from 35 to 39.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • regular medications(e.g., β-blockers, α-blockers, digoxin, diuretics, aspirin,&#xD;
             nitrates, Presently using hormone replacement therapy (HRT) and non steroidal&#xD;
             anti-inflammatory drugs,&#xD;
&#xD;
               -  smoking;&#xD;
&#xD;
               -  cognitive impairment that will make it difficult to partake in the study&#xD;
&#xD;
               -  presence of malignant disease&#xD;
&#xD;
               -  blood donation within the last 6 months&#xD;
&#xD;
               -  Participation as a subject in any type of study or research during the prior 90&#xD;
                  days&#xD;
&#xD;
               -  hypertension,&#xD;
&#xD;
               -  having active chronic illness (e.g., rheumatoid arthritis, hyperthyroidism, and&#xD;
                  inflammatory bowel disease) and diabetes mellitus or other (unstable)&#xD;
                  endocrine-related diseases&#xD;
&#xD;
               -  personal history of cardiovascular diseases,&#xD;
&#xD;
               -  Orthopedic problems inhibiting exercises.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hany fm elsisi, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>physical therapy faculty Cairo university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hany FM Elsisi, phd</last_name>
    <phone>00966580239275</phone>
    <phone_ext>966</phone_ext>
    <email>Elsisihany309@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Physical Therapy</name>
      <address>
        <city>Cairo</city>
        <zip>11432</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>hany fm elsisi, Phd</last_name>
      <phone>00966580239275</phone>
      <phone_ext>966</phone_ext>
      <email>Elsisihany309@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>August 9, 2021</last_update_submitted>
  <last_update_submitted_qc>August 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hany Farid Eid morsy Elsisi</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>2 years after completion study</ipd_time_frame>
    <ipd_access_criteria>journal publishes the study</ipd_access_criteria>
    <ipd_url>http://Scholar.cu.edu.eg/p_t</ipd_url>
  </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/NCT04488341
org study id: P.T.REC/012/002676
nct id: NCT04488341
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
PURPOSE:

      to determine the effect of aerobic exercise training on sex hormones and coagulation factors
      in postmenopausal elderly women

      BACKGROUND:

      Cardiovascular disease (CVD) is the largest cause of death in women, and the risk of
      developing CVD increases after menopause . Because thrombosis is thought to be a cause of
      most acute cardiovascular events, abnormalities in endogenous coagulation and fibrinolysis
      may play an important role in the risk of an acute cardiovascular event. Aging is also
      associated with adverse changes in both coagulation and fibrinolysis. For instance,
      postmenopausal women exhibit higher fibrinogen levels and lower levels of endogenous
      fibrinolysis. Physical activity and physical fitness have consistently been linked to lower
      CVD rates in women. In fact, an inverse association between physical activity and total
      mortality, as well as a 50% reduction in risk of myocardial infarction, has been observed in
      physically active postmenopausal women. In addition to the numerous other benefits provided
      by regular physical activity, one of the mechanisms mediating the cardioprotective effect may
      be changes in the hemostatic system, particularly fibrinolysis

      HYPOTHESES:

      Aerobic exercises may have no effect on sex hormones and coagulation factors in elderly
      postmenopausal women

      RESEARCH QUESTION:

      Do aerobic exercises effect on sex hormones and coagulation factors in elderly postmenopausal
      women in response to exercises?
It is an interventional study in which 40 women estimated to enroll according to random
      allocation and assigned into two groups equally. The study group will receive aerobic
      exercises in addition to diet recommendations while the control group will receive diet
      recommendations. the aerobic exercises time of session 40-50 min initial 10 min warm up
      exercises on treadmill in low intensity and active phase 20- 30 min intensity will increase
      until patient reach to target heart rate then intensity decrease until session will be ended
      by cooling down phase for 10 min . The volunteers will perform exercises 3 times per week for
      12 weeks .coagulation factors(Prothrombin time, Partial Thromboplastin Time , plasminogen
      activator inhibitor-1 , fibrinogen and tissue plasminogen activator )will be measured and sex
      hormones (estradiol ,testosterone. sex hormone binding globin ) pre and post intervention
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: coagulation factors
time frame: 12 weeks
description: change of selected coagulation factors by blood analysis (plasminogen activator inhibitor-1 ,tissue plasminogen activator ,Prothrombin time ,Partial Thromboplastin time ,fibrinogen )
measure: sex hormones
time frame: 12 weeks
description: change of (estradiol ,testosterone. sex hormone binding globin )
measure: weight
time frame: 12 weeks
description: measuring weight in kilograms
measure: height
time frame: 12 weeks
description: measuring height in meters
arm group label: aerobic exercises in addition to diet
arm group type: Other
description: The study group will receive aerobic exercises in addition to diet recommendations
arm group label: diet recommendations
arm group type: Other
description: control group will receive diet recommendations
intervention type: Other
intervention name: aerobic exercises in addition to diet recommendations
description: aerobic exercises time of session 40-50 min initial 10 min warm up exercises on treadmill in low intensity and active phase 20- 30 min intensity will increase until patient reach to target heart rate then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercises 3 times per week for 12 weeks
arm group label: aerobic exercises in addition to diet
intervention type: Other
intervention name: diet recommendations
description: control group will receive diet recommendations for 12 weeks
arm group label: aerobic exercises in addition to diet
arm group label: diet recommendations
criteria: 
gender: Female
minimum age: 60 Years
maximum age: 70 Years
healthy volunteers: No
last name: hany fm elsisi, phd
role: Principal Investigator
affiliation: physical therapy faculty Cairo university
last name: Hany FM Elsisi, phd
phone: 00966580239275
phone ext: 966
email: Elsisihany309@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hany Farid Eid morsy Elsisi
investigator title: principal investigator
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: 2 years after completion study
ipd access criteria: journal publishes the study
ipd url: http://Scholar.cu.edu.eg/p_t