<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/NCT04492540</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/002773</org_study_id>
    <nct_id>NCT04492540</nct_id>
  </id_info>
  <brief_title>Response of Sex Hormones and Different Functions to Exercise and Diet in Elderly Women</brief_title>
  <official_title>Correlation Between Sex Hormones and Different Functions in Response to Aerobic Exercise and MIND Diet in Older Adult 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>
      It is an interventional study in which 60 women estimated to enroll according to random&#xD;
      allocation and divided into two groups. The study group will receive aerobic exercise in&#xD;
      addition to diet restriction while the control group will receive diet recommendations. the&#xD;
      aerobic exercise in form of treadmill training intensity of exercise moderate intensity,&#xD;
      target heart rate (THR) will be 50-60% of heart maximum (HR MAX), time of session 40 min&#xD;
      initial 10 min warm up exercise on treadmill in low intensity and active phase 20- 30 min&#xD;
      intensity will increase until patient reach to THR then intensity decrease until session will&#xD;
      be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per&#xD;
      week for 12 weeks .different functions and markers will be measured and sex hormones&#xD;
      (estradiol ,testosterone. sex hormone binding globin ) pre and post&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PURPOSE:&#xD;
&#xD;
      to determine the effect of aerobic exercise and diet on sex hormones and different functions&#xD;
      and markers, and if is there correlation between two factors effect in postmenopausal elderly&#xD;
      women&#xD;
&#xD;
      BACKGROUND:&#xD;
&#xD;
      Alzheimer's disease (AD) is the most common neurodegenerative disease, accounting for more&#xD;
      than 50% of all dementia types. Its twice more common in females which could be due to&#xD;
      increased longevity and sex difference in brain size .Estrogen has neurotrophic action in&#xD;
      areas involved in memory and cognition. Post-menopausal women are at increased risk than&#xD;
      their male counterpart. Women with Alzheimer have lower endogenous estrogen level which lead&#xD;
      to the hypothesis that estrogen could be neuroprotective. Estrogen and androgen receptors are&#xD;
      widely distributed throughout the brain e.g. in the cerebral cortex, amygdala, hypo-thalamus&#xD;
      and also in the hippocampus which is important for cognitive functioning. There are shown&#xD;
      clear associations between sex hormones and activities in memory, emotional and rewarding&#xD;
      circuits in the brain measured with functional magnetic resonance imaging, several&#xD;
      significant correlations were found between serum hormone levels and spatial ability. High&#xD;
      absolute estrogen levels, a high estrogen/testosterone ratio and increasing levels during&#xD;
      estrogen treatment were all associated with lower spatial ability. This is in agreement with&#xD;
      many previous reports of sex differences where women in general tend to perform worse than&#xD;
      men in this specific aspect of cognitive function. In menstruating women, a deterioration of&#xD;
      spatial ability was demonstrated during high levels of circulating estrogen, and it was&#xD;
      improved during the menstrual phase of the cycle when hormone levels are lowest.&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
      There is no correlation between sex hormones and different functions and markers in response&#xD;
      to aerobic exercise and diet in elderly postmenopausal women&#xD;
&#xD;
      RESEARCH QUESTION:&#xD;
&#xD;
      Is there correlation between sex hormones and different functions and markers in elderly&#xD;
      postmenopausal women in response to aerobic exercise and dietary restriction?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 20, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 30, 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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sex hormones</measure>
    <time_frame>12 weeks</time_frame>
    <description>level of sex hormones(estradiol ,testosterone. sex hormone binding globin )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cognitive functions</measure>
    <time_frame>12 weeks</time_frame>
    <description>cognitive functions by Rowland Universal Dementia Assessment Scale(RUDAS)which has a high score of 30 points, where the least scores indicate severe cognitive impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>functional level</measure>
    <time_frame>12 weeks</time_frame>
    <description>measuring functional level by Functional Independence Measure(FIM) it is ranging from 18 (lowest) to 126 (highest) level of independence: Items are scored on a 7-point ordinal scale, with 7 reflecting complete independency and 1 reflecting total dependence. Scores of 1 to 5 indicate a need for caregiver assistance</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cognitive Decline</condition>
  <condition>Postmenopausal Disorder</condition>
  <arm_group>
    <arm_group_label>aerobic exercise and MIND diet program</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be 60-70% of heart maximum (HR MAX), time of session 60 min initial 10 min warm up exercise on treadmill in low intensity and target phase 40 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet program</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>the control group will receive MIND diet program for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>aerobic exercise and MIND diet program</intervention_name>
    <description>the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be60-70% of heart maximum (HR MAX), time of session 60 min initial 10 min warm up exercise on treadmill in low intensity and target phase 40 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks</description>
    <arm_group_label>aerobic exercise and MIND diet program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MIND diet program</intervention_name>
    <description>control group will receive diet program for 12 weeks</description>
    <arm_group_label>The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Sixty Postmenopausal women (60-70 y)&#xD;
&#xD;
               -  Body mass index (BMI) ranged from 30 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 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;
               -  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;
      </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>ghada e Elrefaye, phd</last_name>
    <role>Study Director</role>
    <affiliation>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>marwadaoud53@yahoo.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>Ghada E Elrefaye, Phd</last_name>
      <phone>0100552715</phone>
      <phone_ext>02</phone_ext>
      <email>marwadaoud53@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>June 17, 2022</last_update_submitted>
  <last_update_submitted_qc>June 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2022</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>Cognitive Dysfunction</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 completing the 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/NCT04492540
org study id: P.T.REC/012/002773
nct id: NCT04492540
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
It is an interventional study in which 60 women estimated to enroll according to random
      allocation and divided into two groups. The study group will receive aerobic exercise in
      addition to diet restriction while the control group will receive diet recommendations. the
      aerobic exercise in form of treadmill training intensity of exercise moderate intensity,
      target heart rate (THR) will be 50-60% of heart maximum (HR MAX), time of session 40 min
      initial 10 min warm up exercise on treadmill in low intensity and active phase 20- 30 min
      intensity will increase until patient reach to THR then intensity decrease until session will
      be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per
      week for 12 weeks .different functions and markers will be measured and sex hormones
      (estradiol ,testosterone. sex hormone binding globin ) pre and post
PURPOSE:

      to determine the effect of aerobic exercise and diet on sex hormones and different functions
      and markers, and if is there correlation between two factors effect in postmenopausal elderly
      women

      BACKGROUND:

      Alzheimer's disease (AD) is the most common neurodegenerative disease, accounting for more
      than 50% of all dementia types. Its twice more common in females which could be due to
      increased longevity and sex difference in brain size .Estrogen has neurotrophic action in
      areas involved in memory and cognition. Post-menopausal women are at increased risk than
      their male counterpart. Women with Alzheimer have lower endogenous estrogen level which lead
      to the hypothesis that estrogen could be neuroprotective. Estrogen and androgen receptors are
      widely distributed throughout the brain e.g. in the cerebral cortex, amygdala, hypo-thalamus
      and also in the hippocampus which is important for cognitive functioning. There are shown
      clear associations between sex hormones and activities in memory, emotional and rewarding
      circuits in the brain measured with functional magnetic resonance imaging, several
      significant correlations were found between serum hormone levels and spatial ability. High
      absolute estrogen levels, a high estrogen/testosterone ratio and increasing levels during
      estrogen treatment were all associated with lower spatial ability. This is in agreement with
      many previous reports of sex differences where women in general tend to perform worse than
      men in this specific aspect of cognitive function. In menstruating women, a deterioration of
      spatial ability was demonstrated during high levels of circulating estrogen, and it was
      improved during the menstrual phase of the cycle when hormone levels are lowest.

      HYPOTHESES:

      There is no correlation between sex hormones and different functions and markers in response
      to aerobic exercise and diet in elderly postmenopausal women

      RESEARCH QUESTION:

      Is there correlation between sex hormones and different functions and markers in elderly
      postmenopausal women in response to aerobic exercise and dietary restriction?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: sex hormones
time frame: 12 weeks
description: level of sex hormones(estradiol ,testosterone. sex hormone binding globin )
measure: cognitive functions
time frame: 12 weeks
description: cognitive functions by Rowland Universal Dementia Assessment Scale(RUDAS)which has a high score of 30 points, where the least scores indicate severe cognitive impairment
measure: functional level
time frame: 12 weeks
description: measuring functional level by Functional Independence Measure(FIM) it is ranging from 18 (lowest) to 126 (highest) level of independence: Items are scored on a 7-point ordinal scale, with 7 reflecting complete independency and 1 reflecting total dependence. Scores of 1 to 5 indicate a need for caregiver assistance
arm group label: aerobic exercise and MIND diet program
arm group type: Other
description: the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be 60-70% of heart maximum (HR MAX), time of session 60 min initial 10 min warm up exercise on treadmill in low intensity and target phase 40 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks
arm group label: The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet program
arm group type: Other
description: the control group will receive MIND diet program for 12 weeks
intervention type: Other
intervention name: aerobic exercise and MIND diet program
description: the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be60-70% of heart maximum (HR MAX), time of session 60 min initial 10 min warm up exercise on treadmill in low intensity and target phase 40 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks
arm group label: aerobic exercise and MIND diet program
intervention type: Other
intervention name: MIND diet program
description: control group will receive diet program for 12 weeks
arm group label: The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet program
criteria: 
gender: Female
minimum age: 60 Years
maximum age: 70 Years
healthy volunteers: No
last name: ghada e Elrefaye, phd
role: Study Director
affiliation: physical therapy faculty Cairo university
last name: marwa m elsayed, phd
phone: 01156033818
phone ext: 02
email: marwadaoud53@yahoo.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: Cognitive Dysfunction
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: one year after completing the study
ipd access criteria: journal publishes the study
ipd url: http://Scholar.cu.edu.eg/p_t