<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/NCT04471506</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/004118</org_study_id>
    <nct_id>NCT04471506</nct_id>
  </id_info>
  <brief_title>Effect of Interval Aerobic Training on Hormonal, Metabolic, and Tumor Markers in Postmenopausal</brief_title>
  <official_title>High-intensity Interval Training Induces Hormonal and Metabolic Effects and Alters Tumor Markers Level in Obese Postmenopausal Women: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      PURPOSE:&#xD;
&#xD;
      to determine the effect of interval training on sex hormones, metabolic and tumor markers&#xD;
&#xD;
      BACKGROUND:&#xD;
&#xD;
      Cancer is one of death top causes in many countries1. In Egypt for example, cancer incidence&#xD;
      is 157.0 per 100 000 women with probability increasing up to three-fold by 2050 especially in&#xD;
      older adult women2. Who exhibit multiple factors leading to cancer including but not limited&#xD;
      to physical inactivity and postmenopausal obesity which considered the starting point of&#xD;
      developing insulin resistance3.&#xD;
&#xD;
      High blood insulin level stimulates cancer progression by enhancing cell proliferation,&#xD;
      decreasing cells apoptosis, increased level of fatty acids in conjunction with higher tumor&#xD;
      cell formation capacity invasion and survival4. Moreover, high level of insulin resistance&#xD;
      and adipose tissue increase the hormonal level of estradiol and testosterone coupled with&#xD;
      lower SHBG level.&#xD;
&#xD;
      It was noticed that being postmenopausal women with high adipose tissue content will increase&#xD;
      the risk of having cancer in which adipose tissue is considered as the main source of&#xD;
      steroids hormones that functioning in a different way rather than in premenopausal age. Based&#xD;
      on the mentioned underlying conditions, postmenopausal women subjected to have variable types&#xD;
      of cancer such as breast, endometrial, stomach, etc6.&#xD;
&#xD;
      So, regular screening of cancer incidence especially in high-risk women through tumor&#xD;
      indicators is necessitated to work against further cancer progression. CEA and CA125 are&#xD;
      low-cost tumor blood biomarkers used widely for early cancer identification, recurrence&#xD;
      monitoring and follow up which linked to proinflammatory cytokines production&#xD;
&#xD;
      .&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
      may have no effect to interval training on sex hormones , metabolic and tumor markers in&#xD;
      postmenopausal women&#xD;
&#xD;
      RESEARCH QUESTION:&#xD;
&#xD;
      Is there effect to interval training on sex hormones , metabolic and tumor markers in&#xD;
      postmenopausal women?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HIIT group involved in an exercise program three times per week for three months in form of&#xD;
      cycling protocol which will comprise 5 minutes warming up before exercise initiation and&#xD;
      another 5 minutes for cooling down by the end of exercise session in form slow pedaling (50%&#xD;
      of PHR). The work interval also will comprise 8-12 cycling intervals (60s cycling work&#xD;
      interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work&#xD;
      intervals that progressively will be reduced until reaching 90s by the end of the exercise&#xD;
      program)17. Each work interval will be maintained at a range of 50-70 rpm (cycle revolutions)&#xD;
      with a speed between 20 and 40 km/h. Exercise intensity will be ≥ 85% of peak heart rate&#xD;
      (PHR) according to the Karvonen formula18.&#xD;
&#xD;
      which corresponds to 8-10 points on the modified Borg scale19. The exercise will be&#xD;
      supervised along the first week only with guidance to ensure that each participant masters&#xD;
      the optimal exercise procedure.&#xD;
&#xD;
      The participants will be equipped with a pulse oximeter for continuous monitoring of the&#xD;
      heart rate prior to the start, during or just after the completion of the exercise session.&#xD;
      Healthy diet instructions will be recommended for those non-dietitian obese women without&#xD;
      following specific diet programs that could influence our results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 12, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>insulin resistance</measure>
    <time_frame>12 weeks</time_frame>
    <description>insulin resistance will be measured by homeostasis model assessment (HOMA) index of change of insulin-resistance by homeostasis model assessment insulin resistance ( HOMA -IR )index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sex hormones</measure>
    <time_frame>12 weeks</time_frame>
    <description>change of sex hormones level (e.g. estradiol ,testosterone. sex hormone binding globin )'</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood lipids</measure>
    <time_frame>12 weeks</time_frame>
    <description>blood lipids will be measured by blood analysis,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tumor markers</measure>
    <time_frame>12 weeks</time_frame>
    <description>tumor markers will be measured by blood analysis,</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>study group will receive interval training and diet advices</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>exercise program in form of a cycling protocol which will be comprised 5 minutes of warming up before exercise initiation and another 5 minutes for cooling down by the end of the exercise session in the form of slow pedaling (50% of PHR). The work interval also will be consisted of 8-12 cycling intervals (60s cycling work interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work intervals that progressively will be reduced until reaching 90s by the end of the exercise program)17.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>diet recommendations</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group will receive diet recommendations. The volunteers will follow diet recommendations for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>interval training in addition to diet recommendations</intervention_name>
    <description>Ixercise program in form of a cycling protocol which will be comprised 5 minutes of warming up before exercise initiation and another 5 minutes for cooling down by the end of the exercise session in the form of slow pedaling (50% of PHR). The work interval also will be consisted of 8-12 cycling intervals (60s cycling work interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work intervals that progressively will be reduced until reaching 90s by the end of the exercise program).</description>
    <arm_group_label>study group will receive interval training and diet advices</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>diet recommendations</intervention_name>
    <description>the control group will follow diet recommendations for 12 weeks</description>
    <arm_group_label>diet recommendations</arm_group_label>
    <arm_group_label>study group will receive interval training and diet advices</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sixty Postmenopausal women (55-65 y)&#xD;
&#xD;
          -  Body mass index (BMI) ranged from 35 to 39.9 kg/m2&#xD;
&#xD;
          -  Postmenopausal more than 2 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • women receiving weight-reduction interventions&#xD;
&#xD;
               -  taking lipid lowering drugs&#xD;
&#xD;
               -  regular medications(e.g., β-blockers, α-blockers, digoxin, diuretics, aspirin,&#xD;
                  nitrates, Presently using sex hormones)&#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;
               -  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 30 days&#xD;
&#xD;
               -  Participation as a subject in any type of study or research during the prior 90&#xD;
                  days&#xD;
&#xD;
               -  smoking&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>marwa m elsayed, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>lecturer at physical therapy faculty cairo university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>marwa m elsayed, phd</last_name>
    <phone>01156033818</phone>
    <phone_ext>02</phone_ext>
    <email>marwadd999@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>marwa m elsayed, Phd</last_name>
      <phone>01156033818</phone>
      <phone_ext>02</phone_ext>
      <email>marwadd999@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>May 7, 2023</last_update_submitted>
  <last_update_submitted_qc>May 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>marwa mahmoud elsayed mahmoud</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>Insulin Resistance</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>one year after completion the study</ipd_time_frame>
    <ipd_access_criteria>students and scientific researchers will be allowed to access</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/NCT04471506
org study id: P.T.REC/012/004118
nct id: NCT04471506
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
PURPOSE:

      to determine the effect of interval training on sex hormones, metabolic and tumor markers

      BACKGROUND:

      Cancer is one of death top causes in many countries1. In Egypt for example, cancer incidence
      is 157.0 per 100 000 women with probability increasing up to three-fold by 2050 especially in
      older adult women2. Who exhibit multiple factors leading to cancer including but not limited
      to physical inactivity and postmenopausal obesity which considered the starting point of
      developing insulin resistance3.

      High blood insulin level stimulates cancer progression by enhancing cell proliferation,
      decreasing cells apoptosis, increased level of fatty acids in conjunction with higher tumor
      cell formation capacity invasion and survival4. Moreover, high level of insulin resistance
      and adipose tissue increase the hormonal level of estradiol and testosterone coupled with
      lower SHBG level.

      It was noticed that being postmenopausal women with high adipose tissue content will increase
      the risk of having cancer in which adipose tissue is considered as the main source of
      steroids hormones that functioning in a different way rather than in premenopausal age. Based
      on the mentioned underlying conditions, postmenopausal women subjected to have variable types
      of cancer such as breast, endometrial, stomach, etc6.

      So, regular screening of cancer incidence especially in high-risk women through tumor
      indicators is necessitated to work against further cancer progression. CEA and CA125 are
      low-cost tumor blood biomarkers used widely for early cancer identification, recurrence
      monitoring and follow up which linked to proinflammatory cytokines production

      .

      HYPOTHESES:

      may have no effect to interval training on sex hormones , metabolic and tumor markers in
      postmenopausal women

      RESEARCH QUESTION:

      Is there effect to interval training on sex hormones , metabolic and tumor markers in
      postmenopausal women?
HIIT group involved in an exercise program three times per week for three months in form of
      cycling protocol which will comprise 5 minutes warming up before exercise initiation and
      another 5 minutes for cooling down by the end of exercise session in form slow pedaling (50%
      of PHR). The work interval also will comprise 8-12 cycling intervals (60s cycling work
      interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work
      intervals that progressively will be reduced until reaching 90s by the end of the exercise
      program)17. Each work interval will be maintained at a range of 50-70 rpm (cycle revolutions)
      with a speed between 20 and 40 km/h. Exercise intensity will be ≥ 85% of peak heart rate
      (PHR) according to the Karvonen formula18.

      which corresponds to 8-10 points on the modified Borg scale19. The exercise will be
      supervised along the first week only with guidance to ensure that each participant masters
      the optimal exercise procedure.

      The participants will be equipped with a pulse oximeter for continuous monitoring of the
      heart rate prior to the start, during or just after the completion of the exercise session.
      Healthy diet instructions will be recommended for those non-dietitian obese women without
      following specific diet programs that could influence our results.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: insulin resistance
time frame: 12 weeks
description: insulin resistance will be measured by homeostasis model assessment (HOMA) index of change of insulin-resistance by homeostasis model assessment insulin resistance ( HOMA -IR )index
measure: sex hormones
time frame: 12 weeks
description: change of sex hormones level (e.g. estradiol ,testosterone. sex hormone binding globin )'
measure: blood lipids
time frame: 12 weeks
description: blood lipids will be measured by blood analysis,
measure: tumor markers
time frame: 12 weeks
description: tumor markers will be measured by blood analysis,
arm group label: study group will receive interval training and diet advices
arm group type: Other
description: exercise program in form of a cycling protocol which will be comprised 5 minutes of warming up before exercise initiation and another 5 minutes for cooling down by the end of the exercise session in the form of slow pedaling (50% of PHR). The work interval also will be consisted of 8-12 cycling intervals (60s cycling work interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work intervals that progressively will be reduced until reaching 90s by the end of the exercise program)17.
arm group label: diet recommendations
arm group type: Other
description: The control group will receive diet recommendations. The volunteers will follow diet recommendations for 12 weeks
intervention type: Other
intervention name: interval training in addition to diet recommendations
description: Ixercise program in form of a cycling protocol which will be comprised 5 minutes of warming up before exercise initiation and another 5 minutes for cooling down by the end of the exercise session in the form of slow pedaling (50% of PHR). The work interval also will be consisted of 8-12 cycling intervals (60s cycling work interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work intervals that progressively will be reduced until reaching 90s by the end of the exercise program).
arm group label: study group will receive interval training and diet advices
intervention type: Other
intervention name: diet recommendations
description: the control group will follow diet recommendations for 12 weeks
arm group label: diet recommendations
arm group label: study group will receive interval training and diet advices
criteria: 
gender: Female
minimum age: 55 Years
maximum age: 65 Years
healthy volunteers: No
last name: marwa m elsayed, phd
role: Principal Investigator
affiliation: lecturer at physical therapy faculty cairo university
last name: marwa m elsayed, phd
phone: 01156033818
phone ext: 02
email: marwadd999@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: marwa mahmoud elsayed mahmoud
investigator title: principal investigator
mesh term: Insulin Resistance
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: one year after completion the study
ipd access criteria: students and scientific researchers will be allowed to access
ipd url: http://Scholar.cu.edu.eg/p_t